MENLO PARK, Calif., June 27, 2019 /PRNewswire/ -- BillionToOne, a venture-backed precision diagnostics company, today announced that the company's first product, UNITY™, is now available for commercial and clinical use. Powered by BillionToOne's patent-pending molecular counting technology, UNITY is the only prenatal screen that tests cell-free fetal DNA for cystic fibrosis, spinal muscular atrophy (SMA) and sickle cell disease using just one tube of blood from the mother. With the completion of analytical and regulatory validation of UNITY, the company will make the test available at select clinics through its Early Access Program with plans for a broader commercial launch later this year.
"We're extremely excited about the commercial launch of UNITY, which will make the existing carrier screening process ten times more accurate and efficient," said Oguzhan Atay, CEO and Co-Founder of BillionToOne. "Making UNITY available through our Early Access Program will be the first step in ensuring that all mothers have access to the information they need to help them better prepare for a safe and healthy pregnancy."
The American College of Obstetricians and Gynecologists (ACOG) recommends that every pregnant woman be screened for her carrier status for cystic fibrosis, SMA, sickle cell disease and thalassemias. While 11 percent of women test positive as a carrier for these conditions, 95 percent of these women will deliver a healthy baby. To confirm that her baby is healthy, however, the mother has to go through the extra step of testing the father's DNA. In many cases, the biological father may not be available, willing or able to get screened, leaving the mother with uncertainty about her child's health status and resulting in missed diagnoses of genetic disorders. Given that 40 percent of babies are born to single mothers, the current carrier screening process is failing when it comes to genetic testing and identifying high-risk pregnancies.
UNITY addresses the many challenges of traditional prenatal screening. It is the first carrier screening with reflex noninvasive prenatal testing for all ACOG-recommended disorders, meaning that once the mother is found to be a carrier, her blood is also analyzed to determine if her baby is at high risk for being affected by the genetic disorder. The entire UNITY screening process takes up to two weeks, compared to 12 weeks or more for traditional carrier screening—saving time and money for parents and reducing workflow for clinicians.
BillionToOne is also improving accessibility to next-generation prenatal testing by billing UNITY through existing insurance codes for carrier testing, which are reimbursed by most insurance providers, including Medicaid. BillionToOne operates a CLIA-certified high-complexity laboratory in Menlo Park, California, where all the samples will be processed. To learn more about UNITY and the Early Access Program, visit www.unityscreen.com.