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Counsyl Secures Approval from New York State Department of Health for Prelude™ Prenatal Screen

Counsyl, a genetic screening and counseling services company, today announced it has received approval from the New York State Department of Health to offer the Counsyl Prelude™ Prenatal Screen in New York. Counsyl can now work more closely with existing and new providers to offer patients early insights about their baby’s development.

Counsyl Prelude™ Prenatal Screen is a non-invasive prenatal screen (NIPS) performed as early as the tenth week of pregnancy that uses cell-free DNA from maternal blood to determine if there is an increased risk for a chromosomal condition like Down syndrome. After a sample of blood is taken, Counsyl uses whole-genome sequencing and combines custom algorithms and bioinformatics with expert analysis. Counsyl Prelude™ is considered more accurate than maternal serum screening with a low test failure rate of 0.1% and successfully reduces the need for invasive procedures like chorionic villus sampling (CVS) or amniocentesis.  

“We are thrilled the state’s medical authority is confident in our technology, which helps us continue our commitment to raising awareness about the importance of genetic screening before and during pregnancy,” said Dr. James Goldberg, chief medical officer at Counsyl. “New York has one of the most rigorous assessments for genetic screening and this endorsement gives credence to the quality and reliability of Counsyl’s technology.”

Since the company’s founding in 2007, Counsyl has championed advances in genetic screening for women and their families and has screened more than 850,000 patients, served more than 17,000 health care providers and provided more than 60,000 genetic counseling sessions.

All of the company’s genetic screening tests, including carrier screening and hereditary cancer screening are available nationwide. In addition, patients have access to Counsyl Complete™, a comprehensive set of support services designed to simplify the implementation of genetic screening.

Counsyl’s suite of products includes:

  • Counsyl Foresight™ Carrier Screen: Identifies carrier status of couples to determine risk of hereditary conditions.

  • Counsyl Prelude™ Prenatal Screen: As early as the tenth week of pregnancy, this non-invasive screening detects a fetus’ risk for chromosomal conditions such as Down syndrome.

  • Counsyl Reliant™ Cancer Screen: Analyzes genes associated with an increased risk of 10 common cancers, including breast, ovarian and pancreatic cancer.

  • Counsyl Complete™: Our complete practice workflow solution, including pre-test education, billing support, clear results reporting and on-demand genetic counseling.

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