Evolve Fertility Genetic Screens  | Evolve Carrier Genetic Screens | Evolve EarlyPregnancy NIPT Screens
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Evolve Fertility Genetic Screens

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  1. What is fertility genetic screening?
  2. How much can your genetics affect your infertility?
  3. Who should have a FertilityReady Screen?
  4. What is chromosome analysis and why is it important?
  5. What is Premature Ovarian Aging or Failure? Why is it important to infertility?
  6. What is Fragile X? Why is it important to infertility?
  7. Do clinics or healthcare providers currently analyze genetic factors of infertility or offer this type of screening?
  8. What professional societies recommend fertility genetic screening?
  9. When is the best time to have Evolve FertilityReady Screens?
  10. At what age should I consider taking Evolve FertilityReady Screens?
  11. At what age should I consider taking the Evolve POF FertilityReady Screen?
  12. Do I need a requisition form from a healthcare provider?
  13. How do I take the test?
  14. What is the turnaround time for results?
  15. How do I find out my results?
  16. What is the Evolve Pre-IVF Genetic Screen?
  17. What are my next steps if I have a positive result?
  18. What information will Evolve FertilityReady Screens provide?
  19. Why are Evolve FertilityReady Screens superior to other screens in the market?
  20. What is the accuracy of Evolve FertilityReady Screens?
  21. Can the Evolve FertilityReady Screens be used to detect chromosome disorders? 
  22. What is the Evolve POF FertilityReady Screen?
  23. Can Evolve FertilityReady Screens replace the need for a polar body biopsy?
  24. If I perform the Evolve Female FertilityReady Screen do I still need to perform Evolve EarlyPregnancy Screens during pregnancy?
  25. What is the difference between genetic fertility screening and genetic carrier screening?
  26. Do Evolve FertilityReady Screens include Complimentary Genetic Counseling?

 

What is fertility genetic screening?

Fertility genetic screening is a type of personalized genetic testing that determines genetic causes of infertility in males and females.  Known genetic causes for infertility include chromosomal abnormalities and genetic mutations. Genetic fertility screening can improve the chances of reproductive & may increase IVF success and help to provide personalized treatment plans.

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How much can your genetics affect your infertility?

It has been estimated that 50% of infertility cases could have a genetic factor. Fertility genetic screening is the missing puzzle piece of the infertility puzzle. Evolve FertilityReady Screens can improve IVF success rates and provide valuable knowledge and insight to you and your healthcare provider regarding your fertility health.

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Who should have a FertilityReady Screen?

Any woman or man with a personal history of infertility or concerns about fertility may benefit from testing.  Certain indications can increase the chance that a genetic factor may be contributing to infertility including in women an elevated follicle-stimulating hormone (FSH) level before age 40 (without a known cause), or a family history of ovarian failure and men with abnormal sperm parameters on semen analysis, or a family history of male infertility.

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What is chromosome analysis and why is it important?

Chromosome analysis evaluates the number and structure of a person’s chromosomes in order to detect abnormalities.  Chromosome analysis can detect abnormalities called aneuploidies and aneusomies as well as translocations, inversions, etc. and is a key component to infertility testing since structural chromosomal abnormalities are a common genetic cause of infertility.

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What is Premature Ovarian Aging or Failure? Why is it important to infertility?

There is a natural decline in ovarian function as a women ages. However, many women have premature aging of the ovaries and this premature aging can occur in as early as a women’s early to mid-20’s. With premature ovarian aging (POA) a women will have a decreased fertility due to a decrease low or sub-optimal number of eggs and poor quality of eggs. Smaller number of lower-quality eggs reduce women’s fertility in two ways: they make it more difficult to get pregnant, and once pregnant, miscarriages are more likely to occur.

Premature Ovarian Failure occurs when ovaries prematurely stop making eggs. Normally this occurs in a woman’s 40s during menopause.

Genetic abnormalities are a significant risk factor for developing POA/POF.

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What is Fragile X? Why is it important to infertility?

The FMR1 (Fragile X Mental Retardation 1) gene is located on the X chromosome. It is of importance to women because not only does the FMR1 premutation put women at significant risk for premature ovarian failure and other fertility issues but are also at an increased risk of having a child with Fragile X syndrome.

Fragile X syndrome is a genetic disorder that causes intellectual disability and various physical and behavioral abnormalities. It is the most common cause of inherited autism in children.

Therefore, the FMR1 premutation puts millions of women at risk of infertility and most have never even heard of it.

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Do clinics or healthcare providers currently analyze genetic factors of infertility or offer this type of screening?

Currently clinics and healthcare providers will only look at genetic factors after multiple IVF or fertility failures and many will not take genetics into consideration. By having this information at the onset of your fertility journey you and your healthcare provider will have the information needed to make better and more informed decisions for better outcomes.

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What professional societies recommend fertility genetic screening?

The American College of Obstetricians and Gynecologists (ACOG) and the American Society for Reproductive Medicine (ASRM) both have policies and recommendations for fertility genetic screening in males and females.

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When is the best time to have Evolve FertilityReady Screens?

Evolve FertilityReady Screens are useful at any time but especially when offered to patients before they undergo IVF or other fertility treatments. These screens should be offered as part of the initial diagnostic evaluation of the patient in a consultation. Evolve FertilityReady Screens will reveal genetic contributions to infertility that cannot be detected by a physical exam of the patient.

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At what age should I consider taking Evolve FertilityReady Screens?

Evolve FertilityReady Screens can be taken at any reproductive age. However, they are recommended as pre-conception screen for individuals before having children or those undergoing assisted reproductive technologies (ART).

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At what age should I consider taking the Evolve POF FertilityReady Screen?

The Evolve POF FertilityReady Screen can be taken as early as a women’s early 20’s to determine if she is at risk of developing premature ovarian aging or failure. However, the screen can be taken at any reproductive age.

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Do I need a requisition form from a healthcare provider?

Yes, at EvolveGene we work with your healthcare provider to order a screening kit for you.

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How do I take the test?

A simple blood or saliva test is needed for fertility genetic screening with EvolveGene.  Convenient sample collection kits for you and your healthcare provider to use are available.

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What is the turnaround time for results?

Please contact us at Support@EvolveGene.com for the most up-to-date turnaround times.

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How do I find out my results?

When your results are ready, you will receive an email alert. Patient reports will be made available for you and your healthcare provider to review. A Board-Certified Genetic Counselor will also be available to you at no extra charge to answer any of your questions and review your results.

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What is the Evolve Pre-IVF Genetic Screen?

Pre-IVF Genetic Screening is a package only available from EvolveGene that includes a FertilityReady Screen + a FamilyReady Screen for a comprehensive reproductive health assessment at the genetic level.

Your genetic makeup plays a significant role in your fertility and it only makes sense that a complete genetic workup should be part of the standard fertility patient evaluation and to help you make informed decisions for the healthiest family possible.

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What are my next steps if I have a positive result?

By understanding if there is a genetic component to you and/or your partner’s infertility you and your healthcare provider will have answers to questions that previously would have gone unanswered. Evolve FertilityReady Screen results will help enable clinicians to proactively devise appropriate management guidelines and effective treatments for patients before experiencing costly and time consuming setbacks from failed fertility treatments.

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What information will Evolve FertilityReady Screens provide?

EvolveGene offers distinct male and female fertility screens, bringing actionable results to help improve your chances of reproductive success.

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Why are Evolve FertilityReady Screens superior to other screens in the market?

EvolveGene is built on 25+ years of expertise in the field of human reproductive medicine with a scientific team of world leading embryologists, geneticists and fertility experts.

The FertilityReady Screens combine comprehensive and advanced technologies to provide a reproductive genetic assessment with one screening option.

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What is the accuracy of Evolve FertilityReady Screens?

NGS for Evolve FertilityReady Screen gene panels has accurate detection rates with >99% analytical sensitivity and false negative rates of <1% for most genes screens. In addition, all cases of FMR1 premutation expansion mutations will be detected by this testing for females; and >99% of Y chromosome deletions will be detected in males.

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Can the Evolve FertilityReady Screens be used to detect chromosome abnormalities?

The Evolve FertilityReady Screens can be used to detect chromosome disorders, such as Klinefelter syndrome, and chromosome abnormalities, such as translocations.

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What is the Evolve POF FertilityReady Screen?

Evolve POF FertilityReady Screen will help you and your healthcare provider if you are at risk for premature decline of your ovarian function.

The Evolve POF FertilityReady Screen includes analysis of genes associated with low or poor amounts of ovarian eggs.

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Can Evolve Fertility Screens replace the need for a polar body biopsy?

Evolve FertilityReady Screens for males and females assess the chromosome status of the parents and do not replace the need for a polar body biopsy which assesses the chromosome status of an embryo. Although the chromosome status of the parents may have some influence to an aneuploidy oocyte, chromosome aneuploidy may still arise during the initial stages of the development of the 1st and 2nd polar bodies. Evolve FertilityReady Screens are best suited for individuals who want to determine genetic factors that may be impacting their fertility or potentially passing on a genetic disease before IVF is performed.

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If I perform the Evolve Female FertilityReady Screen do I still need to perform Evolve EarlyPregnancy Screen during pregnancy?

Yes, because the Evolve FertilityReady Screens look for different genetic factors/conditions than the Evolve EarlyPregnancy Screen each test is important to perform independently. Evolve FertilityReady Screens assess personal genetic factors that can impact fertility. Evolve EarlyPregnancy Screen detects whether chromosome genetic disorders, such as Down syndrome, that are suspected during a pregnancy. Consider having the Evolve Female FertilityReady Screen before a pregnancy as a preconception tool and the Evolve EarlyPregnancy Screen during a pregnancy as a prenatal test.

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What is the difference between genetic fertility screening and genetic carrier screening?

Genetic fertility screening is designed specifically for those individuals with a personal or family history of fertility issues or to assess their genetic risks for infertility.

Genetic carrier screening is designed to determine if individuals are carriers of genetic disorders that could impact their children.

Results from either the type of screening can impact reproductive management options to improve the chances of a successful pregnancy.

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Do Evolve FertilityReady Screens include Complimentary Genetic Counseling?

Yes each FertilityReady Screen includes complimentary pre- and post- screen genetic counseling with a Board Certified Genetic Counselor if requested by the patient or healthcare provider.

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Evolve Carrier Genetic Screens

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  1. What is carrier screening? 
  2. What does it mean to be a carrier? 
  3. What is an autosomal recessive disorder and what is an X-linked disorder?
  4. How severe are genetic disorders?
  5. Who should have carrier screening? 
  6. Are certain ethnicities more at risk of inherited genetic disorders?
  7. What professional societies recommend carrier screening? 
  8. How common is it to be a carrier of a genetic disorder?
  9. When is the best time to have the FamilyReady Carrier Screen?
  10. When is the best time to have the j-FamilyReady Carrier Screen?
  11. When is the best time to have the DonorReady Carrier Screen?
  12. At what age should I consider taking Evolve FamilyReady Carrier Screens?
  13. Do I need a requisition form from a healthcare provider?
  14. How do I take the test?
  15. What is the turnaround time for results?
  16. How do I find out my results?
  17. If my partner and I are both carriers for the same genetic disorder what are the chances our children could have that genetic disorder?
  18. What are some of my options if my partner and I are carriers?
  19. Why would I want to know if I was a carrier?
  20. How does carrier screening help keep my future family healthy?
  21. I have a healthy family and no family history of a genetic disorder, do I still need carrier screening?
  22. If I am a carrier, are my relatives and close family members likely to be carriers as well?
  23. Are there any health conditions that can interfere with the accuracy of my Carrier Screen results?
  24. I already took the Evolve FamilyReady Carrier Screen. Will I ever need to be retested?
  25. What information will Evolve FamilyReady Carrier Screens provide?
  26. What information will Evolve j-FamilyReady Carrier Screens provide?
  27. What information will Evolve DonorReady Carrier Screens provide?
  28. Why choose Evolve Carrier Genetic Screens? What makes it superior to other screens in the market?
  29. What is deletion/duplication analysis and why is it important?
  30. What is the accuracy of the Evolve Carrier Genetic Screens?
  31. What is the difference between the Evolve FertilityReady Screens and the Evolve Carrier Genetic Screens?
  32. Does screening include Complimentary Genetic Counseling?

 What is carrier screening?

Carrier screening is a type of personalized genetic testing that can help determine if you are a carrier of a genetic change or mutation in your DNA that could possibly lead to serious inherited genetic disorders in your children.  The genetic disorders detected with carrier screening are typically autosomal recessive disorders (ex. Cystic Fibrosis, Tay-Sachs Disease) or X-linked disorders (Fragile X syndrome, Duchenne Muscular Dystrophy). These genetic disorders can significantly impact the health of a person and alter life expectancy.

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 What does it mean to be a carrier?

Anyone can be a carrier of a genetic disorder.  In almost all cases carriers are healthy and free of symptoms, but they are at risk of passing on a genetic mutation to their children. If you and your partner are carriers for the same recessive disorder, then there is a 25% risk with every pregnancy to have a child affected with this recessive disorder.  If you are a female carrier of an X-linked disorder then there is a 50% risk with every pregnancy to have a child affected with this X-linked disorder depending on the child’s gender.

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 What is an autosomal recessive disorder and what is an X linked disorder?

We have 23 pairs of chromosomes: half are inherited from your mother and the other half are inherited from your father. Pairs 1-22 are considered the autosomal chromosomes. The 23rd pair of chromosomes are the sex chromosomes which determine your sex (XX is female, XY is male). Autosomal recessive disorders are caused by mutations on any of the autosomal chromosomes and X linked disorders are caused by mutations on the X chromosome.

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How severe are genetic disorders?

The genetic disorders screened for during carrier screening can severely affect the health of your children.  Many of the genetic disorders are life-threatening and cause both physical and intellectual disabilities with no access to curative treatments.  Other genetic disorders, although not life-threatening, can impact life by requiring chronic management with progressive symptoms, while others still may be managed early in life with treatment.  The crucial step is determining your carrier status in order to determine what genetic disorders your children may be at risk to inherit.

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Who should have carrier screening?

Everyone should have carrier screening, especially those who are pregnant or thinking of getting pregnant.  Approximately 24% of the general population is a carrier of at least one genetic disorder.  Your ethnicity alone can put you at an increased risk of being a carrier since some genetic disorders are more common in certain populations.

Example: Carrier frequencies for cystic fibrosis (a recessive lethal genetic disorder)

African American 1 in 61

Ashkenazi Jewish 1 in 24

Asian 1 in 94

European 1 in 25

Hispanic/Latino 1 in 58

Mediterranean 1 in 29

It is highly recommended that all couples with ANY Jewish ancestry, including interfaith couples, have carrier screening due to the significantly higher risk in this population being carriers for genetic disorders.

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Are certain ethnicities more at risk of inherited genetic disorders?

Yes, there is a greater risk to be a carrier of certain genetic conditions depending on your ethnic background. For example, individuals of Ashkenazi Jewish descent have an increased risk to be carriers of recessive genetic conditions such as Gaucher Disease and Tay-Sachs. Whereas, individuals of Asian and African-American descent have a greater risk to be carriers of hereditary forms of anemia such as Alpha-Thalassemia and Sickle Cell Anemia.

Even though certain ethnicities are more at risk for certain genetic conditions, carrier screening should be done by ALL individuals regardless of ethnicity since many individuals cannot state their ethnicity correctly and many individuals can have genetic information from multiple ethnicities as well.

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What professional societies recommend carrier screening?

Both the American College of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics (ACMG) recommend all women have some form of carrier screening if they are of reproductive age.  ACOG recently released recommendations that all women should be offered pre-pregnancy genetic screening, such as expanded carrier screening.  Other professional societies with policies recommending carrier screening include the National Society of Genetic Counselors (NSGC), the Perinatal Quality Foundation (PQF), and the Society for Maternal-Fetal Medicine (SFMF).

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How common is it to be a carrier of a genetic disorder?

With advancements in personalized genetic screening and worldwide availability of comprehensive expanded carrier screen panels, the chance to be detected as a carrier of a genetic disorder is extremely common.

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When is the best time to have the FamilyReady Carrier Screening?

Before a pregnancy is the best time to have any carrier screening to help you plan and make informed decisions for the healthiest family possible.  The FamilyReady Carrier Screen can be used by couples as a preconception test.  However, carrier screening is commonly performed during a pregnancy as well.

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When is the best time to have the j-FamilyReady Carrier Screening?

Before a pregnancy is the best time to have any carrier screening to help you plan and make informed decisions for the healthiest family possible. It is professionally recommended that individuals with any Jewish ancestry have carrier screening.  The j-FamilyReady Carrier Screen can be used by couples with Jewish ancestry as a premarital or preconception test.

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When is the best time to have the DonorReady Carrier Screening?

The DonorReady  Carrier Screen is designed for reproductive sperm or egg donors before any assisted reproductive techniques, such as IVF.  Donors who are carriers need not necessarily be excluded from use if the reproductive partner has had appropriate carrier screening, such as the FamilyReady Carrier Screen.

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At what age should I consider taking Evolve FamilyReady Carrier Screens?

Evolve FamilyReady Carrier Screen can be taken at any age, however it is of most use to individuals who are of reproductive age.

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Do I need a requisition form from a healthcare provider?

Yes, at EvolveGene we work with your healthcare provider to order a carrier screening kit for you.

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How do I take the test?

Either before or during a pregnancy, a simple saliva or blood test can determine your carrier status.  EvolveGene provides convenient sample collection kits for you and your healthcare provider to use.

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What is the turnaround time for results?

Please contact us at Support@EvolveGene.com for the most up-to-date turnaround times.

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How do I find out my results?

When your results are ready, you will receive an email alert. Patient reports will be made available for you and your healthcare provider to review. A Board-Certified Genetic Counselor will also be available to you at no extra charge to answer any of your questions and review your results.

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If my partner and I are both carriers for the same genetic disorder what are the chances our children could have that genetic disorder?

If you and your partner are both carriers of the same autosomal recessive disorder (e.g. Cystic Fibrosis, Sickle Cell Anemia, or Tay-Sachs Disease, etc.) then with every pregnancy there is a:

  • 25% chance of your child having the genetic disorder
  • 50% chance of your child being a carrier like you and your partner
  • 25% chance of your child neither having the disorder nor being a carrier

If the mother is a carrier of an X linked disorder (i.e. Fragile X syndrome, or Duchene Muscular Dystrophy) then only the mother needs to be a carrier to pass the disorder onto her children. Boys receive their X chromosome from their mother and their Y chromosome from their father. Therefore, if the carrier mother gives her son the X chromosome with the mutation then the son will have that disease. If the carrier mother gives her daughter the X chromosome with the mutation, then the daughter will be a carrier of the disorder like her mother.

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What are some of my options if my partner and I are carriers?

Our Board-Certified Genetic Counselors can speak with you and your healthcare providers to better explain the Evolve FamilyReady Carrier Screen and the genetic disorder or disorders you are at risk of passing onto your child. Your healthcare provider can then work with you and your partner regarding your reproductive options.

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Why would I want to know if I was a carrier?

A large portion of the general population are unknowingly healthy carriers of a genetic disorder. If both parents are carriers of the same autosomal recessive disorder then there is a 25% chance for each of their children to be affected with this disorder If a mother is a carrier of an X-linked disorder then there is a 50% chance each of her children will be affected with the disorder depending on their gender.

This valuable information will allow you and your partner to know if your child is at risk to have a serious genetic disorder prior to conception. This knowledge will enable you to be prepared and be proactive about the future health of your family.

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How does carrier screening help keep my future family healthy?

Knowing that a child is at risk for a genetic disorder can allow a family to make appropriate management plans. For example, phenylketonuria (PKU) is a genetic disorder that can lead to severe intellectual disabilities and potentially death if not treated. Many countries have developed newborn screening (NBS) programs to screen for genetic conditions such as PKU during the first week of life. However, if parents know their carrier status’ and know their child is at risk for a genetic disorder, they can save time, and establish a diagnosis either prenatally or earlier during the newborn period in order to begin treatment to prevent complications from the disease.

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I have a healthy family and no family history of a genetic disorder, do I still need carrier screening?

Yes, having a healthy family does not necessarily mean that you and your partner are not carriers of a genetic disorder. Most people who have a child with a recessive disorder do not have a family history of the condition.

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If I am a carrier, are my relatives and close family members likely to be carriers as well?

If you are a carrier, then yes it is more likely that your family members are also carriers for the same disorder.

You received your genetic mutation from either your mother or father. Therefore, your parents and grandparents should consider testing to determine which side of the family the genetic mutation was inherited from.

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Are there any health conditions that can interfere with the accuracy of my Carrier Screen results?

A history of bone marrow transplantation or recent blood transfusions can limit our ability to provide accurate results. We also advise waiting at least two months after undergoing a blood transfusion procedure before proceeding with a Carrier Screen.

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I already took the Evolve FamilyReady Carrier Screen. Will I ever need to be retested?

You should consider retaking the Evolve FamilyReady Carrier Screen if you have a different partner for a pregnancy or if you took the test several years ago. The Evolve FamilyReady Carrier Screen is updated with additional genetic disorders and mutations to keep pace with advancing research; we recommend if your results are more than 2 years old to repeat the carrier screen.

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What information will Evolve FamilyReady Carrier Screens provide?

Evolve FamilyReady Carrier Screen – Testing of genes associated with genetic disorders that impact all ethnic groups. Offering an advanced and in-depth expanded carrier screen.

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What information will Evolve j-FamilyReady Carrier Screens provide?

Evolve j-FamilyReady Carrier Screen- Testing of genes associated with genetic disorders found in those of Jewish descent including those from Ashkenazi and Sephardic populations.

Individuals of Jewish descent have a greater chance to be carriers for conditions.

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What information will Evolve DonorReady Carrier Screens provide?

Evolve DonorReady Carrier Screen- Advanced carrier screen for prevalent and relevant disorders developed specifically for sperm and egg donors.  With optional MolecularKaryotype for a reproductive genetic assessment screen of donors.

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Why choose Evolve Carrier Genetic Screens? What makes it superior to other screens in the market?

Evolve Carrier Genetic Screens were developed by leading geneticists for reliable and advanced personalized genetic screening of medically relevant genetic disorders:

With the FamilyReady the accurate expanded carrier screen across all ethnicities; the j-FamilyReady carrier screen specialized for genetic disorder seen more frequently  in this population (e.g. Tay Sachs Disease); and the DonorReady carrier screen of prevalent and relevant genetic disorders designed for reproductive donors to provide a thorough screen.

What makes the Evolve Carrier Genetic Screens superior to other competitors in the market is the fact that we perform complete analysis with advanced Next Generation Sequencing (NGS) technologies.  Each carrier screen includes Full Gene Sequencing Analysis + Deletion/ Duplication Analysis.

By including Deletion/Duplication Analysis, at no additional cost, EvolveGene is providing you increased reliability and superior results. Deletion/Duplication Analysis is routinely offered as a reflex test, at an additional cost, after a negative result on the initial screening test.

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What is deletion/duplication analysis and why is it important?

EvolveGene is the only genetic screening company that includes Deletion/Duplication Analysis as part Carrier Screening for genes included on panels. Deletion/Duplication Analysis is a critical 2nd step of carrier screening. Deletion/Duplication Analysis evaluates genes with a different technical method to provide results on large deletions or duplications of genetic material that would be missed with only traditional carrier screening. This analysis improves the detection rate of disease causing mutations: for genes which increases accuracy to >99%.

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What is the accuracy of the Evolve Carrier Genetic Screens?

Evolve Carrier Genetic Screens are advanced genetic tests utilizing cutting-edge Next Generation Sequencing (NGS) technologies.

NGS has accurate detection rates with >99% analytical sensitivity and false negative rates of <1%. Evolve Carrier Genetic Screens also include highly precise Fragile X Analysis + Spinal Muscular Atrophy Analysis + Alpha-Thalassemia Analysis + more.

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What is the difference between the Evolve FertilityReady Screens and the Evolve Carrier Genetic Screens?

Evolve FertilityReady Screens are designed specifically for those individuals with a personal or family history of fertility issues or to assess their genetic risks for infertility.

Evolve Carrier Genetic Screens are designed for to determine if individuals are carriers of genetic disorders that could impact their children.

Results from either the Evolve FertilityReady Screens and the Evolve Screens can impact reproductive management options including pre-IVF care to improve the chances of a successful pregnancy.

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Does screening include Complimentary Genetic Counseling?

Yes, each Evolve Screen has available complimentary pre- and post- screen genetic counseling with a Board-Certified Genetic Counselor.

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Evolve EarlyPregnancy NIPT Screens

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  1. What is Non-Invasive Prenatal Testing (NIPT)?
  2. How does NIPT work?
  3. What are chromosome abnormalities?
  4. How severe are chromosome abnormalities?
  5. Who should have NIPT?
  6. Can NIPT be used in pregnancies of multiples?
  7. What professional societies recommend NIPT?
  8. When is the best time to have EarlyPregnancy Screening?
  9. Do I need a requisition form from a healthcare provider?
  10. What happens if a physician suspects a pregnancy of twins and wants to order the EarlyPregnancy Screen?
  11. How do I take the test?
  12. What is the turnaround time for results?
  13. How do I find out my results?
  14. Why should I have NIPT instead of traditional prenatal screening?
  15. What are my next steps if I have a “Positive: Aneuploidy/Abnormality detected” result?
  16. What are my next steps if I have a “Negative: No Aneuploidy/Abnormality detected” result?
  17. What information will EarlyPregnancy Screens provide?
  18. Why is EarlyPregnancy Screening superior to other NIPTs in the market? 
  19. Why is Whole Genome Sequencing (WGS) better than other sequencing (i.e. targeted) for NIPT?
  20. What is the accuracy of the EarlyPregnancy Screen?
  21. Is the EarlyPregnancy Screen an NIPT applicable to pregnancies achieved with egg donors?
  22. What is the difference between the Evolve FamilyReady Carrier Screen and the Evolve EarlyPregnancy Screen? 
  23. Do Evolve EarlyPregnancy Screens include Complimentary Genetic Counseling? 

 

What is Non-Invasive Prenatal Testing (NIPT)?

NIPT is a method to screen for specific chromosome abnormalities without risk of miscarriage or harm to your baby. It delivers safe and reliable information about the health status of your baby during pregnancy as early as 10 weeks with a simple blood test from the mother.

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How does NIPT work?

By 10 weeks in a pregnancy, approximately 10% of the cell-free DNA found circulating in the mother’s blood stream comes from the baby. This is sufficient genetic material to screen for the likelihood of your baby having a chromosome abnormality.

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What are chromosome abnormalities?

Chromosome abnormalities occur when there is a numerical or structural change in a person’s chromosomes. Numerical changes include extra or missing chromosomal numbers which deviate from the normal 46 chromosomes in each cell. Examples of numerical chromosomal changes include trisomy 21 (i.e. Down syndrome), in which a person has an extra chromosome 21 and Klinefelter syndrome, in which a male has an extra X chromosome.

Structural changes deal with rearrangements or abnormalities with may impact one part of a chromosome in particular, such as a deletion on chromosome 4. Many structural chromosomal changes are referred to as microdeletion syndromes and are screened for during the EarlyPregnancy NIPT Plus Screen.

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How severe are chromosome abnormalities?

Chromosome abnormalities have major genetic consequences and can impact everything from a person’s IQ level to whether they will have infertility.

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Who should have NIPT?

NIPT should be offered to ALL women early in pregnancy. NIPT is particularly suitable for pregnant women with the following indications:

  • Maternal age-related risks
  • Abnormal serum screen or ultrasonographic findings
  • Family history of chromosome abnormalities
  • Pregnancies conceived through IVF or with ART

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Can NIPT be used in pregnancies of multiples?

NIPT is currently validated for use in only singleton and twin pregnancies.

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What professional societies recommend NIPT?

Both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recommend NIPT as part of the screening options for all pregnancies to allow each person to make informed choices based on their values and goals. Other professional societies with policies recommending NIPT include the American College of Medical Genetics (ACMG) and the National Society of Genetic Counselors (NSGC).

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When is the best time to have EarlyPregnancy Screening?

EarlyPregnancy Screening can be used as early as the 10th week of pregnancy.

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Do I need a requisition form from a healthcare provider?

Yes, we work with your healthcare provider to order an Evolve EarlyPregnancy NIPT Screen kit for you.

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What happens if a physician suspects a pregnancy of twins and wants to order the Evolve EarlyPregnancy Screen?

If your physician is suspicious that you are carrying a twin pregnancy, please ensure the requisition form is completed for the twin pregnancy selection.

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How do I take the test?

EarlyPregnancy Screening requires just one routine blood draw tube from the expectant mother and can be administered as early as 10 weeks gestational age. EvolveGene provides convenient sample collection kits for you and your healthcare provider to use.

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What is the turnaround time for results?

Please contact us at Support@EvolveGene.com for the most up-to-date turnaround times.

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How do I find out my results?

When your results are ready, you will receive an email alert. Patient reports will be made available for you and your healthcare provider to review. A Board-Certified Genetic Counselor will also be available to you at no extra charge to answer any of your questions and review your results.

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Why should I have NIPT instead of traditional prenatal screening?

NIPT provides significantly better risk indication than traditional prenatal screening and is quickly becoming standard of care for all women during a pregnancy. Traditional prenatal screening often involves a series of blood draws throughout a pregnancy to establish a risk for chromosome abnormalities. NIPT only involves one blood draw and can be completed during the first trimester. NIPT also results in fewer false positives than traditional prenatal screening which decreases the need for risky invasive procedures.

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What are my next steps if I have a “Positive: Aneuploidy/Abnormality detected” result?

A positive NIPT result can guide you through the next steps in your prenatal care. It is recommended that no irreversible clinical decisions be made based on these screening results alone. The option of confirmatory diagnostic testing (e.g. amniocentesis) is an important follow-up discussion for you and your healthcare provider.

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What are my next steps if I have a “Negative: No aneuploidy/abnormality detected” result?

 

A negative NIPT result significantly reduces the risk for a chromosome abnormality in your pregnancy without undergoing invasive diagnostic procedures.

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What information will EarlyPregnancy Screens provide?

Evolve EarlyPregnancy NIPT Screen determines if a pregnancy has an elevated risk for the most common chromosomal abnormalities including Trisomy 21 (Down syndrome), Trisomy 18 (Edwards syndrome), and Trisomy 13 (Patau syndrome).  Additional information on sex chromosome disorders, XY determination is available for singleton pregnancies, and additional information on the presence of Y chromosome detection is available for  twin pregnancies.

Evolve EarlyPregnancy NIPT Plus Screen is available for singleton pregnancies with the same options available as the EarlyPregnancy Screen in addition to optional  microdeletions  and/or the all chromosome analysis.

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Why is EarlyPregnancy Screening superior to other NIPTs in the market?

EarlyPregnancy Screens are powered by the deepest massively parallel whole genome sequencing (WGS) approach with high detection rates for chromosome aneuploidies and a low technical failure rate at 0.1%.

Having a low technical failure rate allows for more reliable results, fewer redraws of samples, and faster turn-around times than other NIPT providers.

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Why is Whole Genome Sequencing (WGS) better than other sequencing (i.e. targeted) for NIPT?

WGS methods are more comprehensive than targeted methods because WGS includes analysis of the entire genomic region rather than only specific, “targeted”, regions. WGS also allows for the ability to easily add new content to the test menu since it captures all genomic data; whereas in targeted methods there is a limited ability to add any new content without having to change the test itself.

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What is the accuracy of the EarlyPregnancy Screen?

Evolve EarlyPregnancy Screen offers highly accurate NIPT performance with a superior analysis algorithm. Detection rates for chromosome abnormalities, such as Down syndrome (Trisomy 21) is greater than 99%.

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Is the EarlyPregnancy Screen an NIPT applicable to pregnancies achieved with egg donors?

Yes. The EarlyPregnancy Screen is one of the only NIPT service providers that can be used in pregnancies achieved with egg donors.

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What is the difference between the Evolve FamilyReady Carrier Screen and the Evolve EarlyPregnancy Screen?

Evolve FamilyReady Carrier Screen is designed for both males and females to determine if either are carriers of genetic disorders that could impact their children. Evolve EarlyPregnancy Screen is specifically designed to screen for multiple chromosome abnormalities that could be affecting a current pregnancy. Thus, the FamilyReady Carrier Screen is best used before a pregnancy to determine if children will be at risk for any genetic disorders; while the EarlyPregnancy Screen is used during a pregnancy after 10 weeks gestation to screen for chromosome abnormalities that may be present after conception.

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Do Evolve EarlyPregnancy Screens include Complimentary Genetic Counseling?

Yes, each Evolve EarlyPregnancy Screen has available complimentary pre- and post- screen genetic counseling with a Board-Certified Genetic Counselor.

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Billing & Support

Return to Categories

  1. What are ICD-10 codes?
  2. What are CPT (Current Procedure Terminology) codes?
  3. What are the CPT codes for Evolve Screens?
  4. Who can I contact for support on billing issues?
  5. How are orders registered?
  6. Can screens be ordered without a healthcare provider?
  7. Can healthcare providers order multiple screening kits for their clinics?
  8. How are sample kits sent back to Evolve?
  9. What is a genetic consultation?
  10. How can I schedule a genetic consultation?
  11. Does Evolve offer genetic consultations in different languages?
  12. Can you tell me more about international orders and consults?

 

What are ICD-10 codes?

The World Health Organization created the International Classification of Disease, tenth revision (ICD-10) as a system of coding for medical records including diseases, symptoms, and abnormal findings.  These standards are accepted throughout the healthcare industry for a diagnostic coding system.

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What are CPT (Current Procedure Terminology) codes?

CPT codes are identifying codes given to a medical/diagnostic procedure that describes the services rendered. These codes are used by hospitals, physicians, and healthcare providers to communicate procedures or tests ordered to your insurance carrier.

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What are the CPT codes for Evolve Screens?

More information on CPT codes commonly used to order Evolve Screens can be found on the requisition form.

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Who can I contact for support on billing issues?

Please contact us at support@EvolveGene.com if you have questions regarding billing.

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How are orders registered?

After a screening kit is ordered, a healthcare provider submits a requisition form to EvolveGene and a patient registers the kit through our online portal on EvolveGene.com prior to sample collection.

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Can screens be ordered without a healthcare provider?

No, each Evolve Screen is a clinical laboratory test that requires a healthcare provider’s  approval prior to screening under current laws and regulations.

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Can healthcare providers order multiple screening kits for their clinics?

Yes, you can order multiple screening kits for your clinics.  A patient could then purchase a kit directly in clinic when needed.

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How are sample kits sent back to Evolve?

To send sample kits back to Evolve, please enclose kit inside the prepaid envelope to ensure free shipping to our laboratory.

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What is a genetic consultation?

Evolve genetic consultations ensure you have access to expert and compassionate services.  During consultations, your results will be explained in the context of your fertility, family, and medical history.

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How can I schedule a genetic consultation?

Our team of trained and board certified genetic counselors are on hand to make certain genetic screening is as understandable as possible.  Genetic consultation services are available at no additional cost for both healthcare providers and patients.  Please contact us at specialists@EvolveGene.com to schedule a genetic consultation.

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Does Evolve offer genetic consultations in different languages?

Yes, at Evolve our complimentary genetic counseling is accessible to everyone by working with certified interpreters if a language other than English is spoken.

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Can you tell me more about international orders and consults?

To find out if Evolve Screens are available in your country, please contact us at support@EvolveGene.com.

If an interpreter is required for a consultation, please indicate the requested language along with the your international phone number (including country code) when scheduling a genetic consultation.

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