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Clarify true risk in non-invasive prenatal screening

Counsyl patients

The Counsyl Informed Pregnancy Screen uses cell-free DNA to determine if there is an increased risk for common aneuploidies such as Down syndrome.

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Lacey O.Counsyl Informed Pregnancy Screen patient

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cfDNA screening for common aneuploidies

Cell-free DNA (cfDNA) screening has been shown to be superior to methods that use maternal age, ultrasound, and serum screening, resulting in a lower false positive rate and false negative rate.1 The Counsyl Informed Pregnancy Screen can be offered to all women, including those with an ovum donor or twin pregnancies. Conditions covered include:

Microdeletion and sex chromosome screening are optional.
While looking at sex chromosomes, we can report the fetal sex.

Screening done responsibly

The ACOG/SMFM guidelines on cfDNA for fetal aneuploidy provide important guidance on how to integrate screening into clinical practice.

More than any other lab, Counsyl is aligned with ACOG/SMFM guidelines for non-invasive prenatal screening. Learn more about how we have put guidelines into action.

Conditions covered
Common aneuploidies
(opt-in: sex chromosomes and microdeletions)
When to screen
As early as 10 weeks into pregnancy
Sample type
Two 10mL blood samples
Massively parallel sequencing
Turnaround time
Results in 1 week on average
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Clarifying true risk with individualized PPV

Individualized PPV and residual risk estimates provide a more accurate picture of a patient’s chance to have an affected pregnancy. This is why they are recommended by SMFM/ACOG in results reporting3,4 — and why we include them on our reports.

Guidelines into action
Counsyl is the first and only lab to implement ACOG/SMFM’s recommendation3,4 to include individualized PPV* (positive predictive value) and residual risk estimates on reports.

Why Individualized PPV?
Individualized PPV is a more accurate way of translating what a positive result actually means for each patient. It’s the chance that a screen positive is actually a true positive result for a particular patient — factoring in maternal and gestational age.

Transparency in results reporting
Calculating and reporting patient-specific PPV on each test result* helps you clarify a patient’s true risk and guide next steps for your patient’s care.

Learn more about why individualized PPV matters »

Sample Informed Pregnancy Screen Report

Sample Informed Pregnancy Screen Report

Methodology matters

The Counsyl Informed Pregnancy Screen uses massively parallel sequencing (MPS) which deeply sequences all the DNA, With massively parallel sequencing, we see the lowest no-call rate in the industry of just 0.1%.2

And because ACOG/SMFM recommend treating no-calls the same as you would a screen positive3,4, there is an important clinical advantage to having a low test failure rate. It means fewer redraws, fewer invasive procedures, shorter overall turnaround, and decreased anxiety for your patients.

Genetic counseling for all patients

ACOG/SMFM recommends genetic counseling for all patients, even for test negatives because "a negative cfDNA test result does not ensure an unaffected pregnancy.3"

We are the only lab that offers genetic counseling to all patients. With Counsyl, a patient can be speaking to an expert within minutes of receiving their test results. We want to do everything we can to reduce anxiety and ensure that patients understand the meaning of their results.

Our platform

The Counsyl platform delivers education, guidance and support for clinicians and patients at every step of the testing process.

We take the burden of billing of your hands

As an in-network lab, Counsyl screening is a covered benefit for many of your patients. We work directly with patients and their insurance to determine coverage and provide cost estimates.

We also offer payment options for patients who lack adequate coverage.

Enabling broader screening

Results are available online so you can quickly review and release to patients. Post-test education and on-demand access to a board-certified genetic counselor are included for all patients to ensure results are clearly understood.

And, we document every interaction so you have full visibility to all patient communications.

Lacey and her fiancé Sejin
Taking it has helped me sleep better because getting answers – one way or the other – is a huge relief.Lacey, 32 (pictured with fiancé Sejin)
Counsyl Informed Pregnancy Screen patient, expecting her first baby girl
Read her story

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References:*PPV and residual risks provided on all results for trisomy 13, trisomy 18 and trisomy 21 in singleton pregnancies, based on the maternal age and gestational age of the patient. 1. Bianchi et al. (2014). DNA sequencing versus standard prenatal aneuploidy screening. NEJM, 370(9): 799-808. 2. Taneja et al. Noninvasive prenatal testing in the general obstetric population: clinical performance and counseling considerations in over 85000 cases†. Prenatal Diagnosis 2016, 36, 1–7. 3. Cell-free DNA screening for fetal aneuploidy. Committee Opinion No. 640. American College of Obstetricians and Gynecologists. Obstet Gynecol 2015;126:e31–7 4. Society for Maternal-Fetal Medicine (SMFM) Publications Committee. #36 Prenatal aneuploidy screening using cell-free DNA. AJOG 2015, 212(6):711-716

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