The Unity Confirm test uses fetal cell capture technology to provide diagnostic insights from a maternal blood draw for high-risk screening results.
BillionToOne Inc announced the launch of Unity Confirm, a non-invasive prenatal confirmation test that isolates intact fetal cells from a maternal blood draw. The test is designed to provide diagnostic insights for patients who receive high-risk results from screening but wish to avoid invasive procedures.
The test addresses a clinical gap between non-invasive prenatal testing and invasive diagnostics such as chorionic villus sampling or amniocentesis. While non-invasive prenatal testing is the standard for screening for fetal aneuploidies, clinical guidelines recommend confirmation through invasive procedures when a high-risk result occurs. These procedures carry a risk of pregnancy loss and are increasingly difficult to access, according to a press release from BillionToOne.
Unity Confirm uses Fetal Cell Capture technology, which involves a multi-step immunological enrichment and single-cell isolation process. The technology isolates intact circulating fetal cells and performs whole genome sequencing on each individual cell. By analyzing direct fetal cells instead of fragmentary cell-free DNA, the test delivers insights similar to chorionic villus sampling from a single blood draw.
“For years, the idea of capturing whole fetal cells non-invasively was largely viewed as an elusive holy grail, something theoretically possible but practically out of reach,” says Oguzhan Atay, PhD, co-founder and CEO of BillionToOne, in a release. “Unity Confirm is proof that it does not have to be.”
In a clinical validation study, the test demonstrated 100% concordance with known fetal outcomes and invasive results across 16 samples. These samples included affected fetuses for common aneuploidies and 22q11.2 microdeletion. To validate performance at scale, the company is enrolling 1,000 patients in a prospective study to measure concordance to invasive diagnostic testing.
“What makes Unity Confirm truly different is not just the science; it is that this capability is now clinically accessible,” says Haywood Brown, MD, chief medical officer of prenatal at BillionToOne, in a release. “That’s not an incremental improvement. That is a fundamentally different standard of care.”
Beginning May 28, providers using the Unity Aneuploidy Screen will have access to the test following a high-risk result. The test is intended for patients who cannot or choose not to pursue invasive testing before 16 weeks of gestation. It is available for Trisomy 21, Trisomy 18, Trisomy 13, 22q11.2 microdeletion, and sex chromosome aneuploidies.
ID 27686757 © Retina2020 | Dreamstime.com
