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.
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.
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.
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.
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.
The Counsyl platform delivers education, guidance and support for clinicians and patients at every step of the testing process.
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.
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.
Submit your information and we will reach out to you directly.Offer Counsyl at Your Clinic
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