BillionToOne (Nasdaq: BLLN) has launched Unity Confirm, a non-invasive prenatal confirmation test that captures and sequences intact circulating fetal cells from a maternal blood draw – bridging the gap between screening and invasive diagnostic procedures like amniocentesis and CVS.
The test addresses a longstanding clinical problem: when non-invasive prenatal testing (NIPT) returns a high-risk result, guidelines recommend confirmation via CVS or amniocentesis, but these invasive procedures carry a small risk of pregnancy loss and are increasingly difficult to access. The majority of patients decline, leaving families and clinicians without the information needed to guide next steps.
Capturing intact fetal cells non-invasively has been a long-standing goal in prenatal genetics – fetal cells present at fewer than one cell per milliliter of blood and are nearly indistinguishable from millions of surrounding maternal cells. BillionToOne’s Fetal Cell Capture technology uses a multi-step immunological enrichment and single-cell isolation process to isolate intact circulating fetal cells, effectively providing 100% fetal fraction, and performs whole genome sequencing on each individual cell.
“For the first time, a clinician can confirm a high-risk prenatal result non-invasively, with a level of accuracy the field has never before seen outside of an invasive procedure,” said co-founder and CEO Oguzhan Atay, PhD. “For the first time, this technology is broadly accessible.”
“A high-risk NIPT result does not give you a diagnosis. It gives you a decision to make under enormous stress, often without enough information,” said chief medical officer Haywood Brown, MD. “For too long, the options were limited: forgo confirmation, or undergo an invasive procedure with a small but real risk. What makes Unity Confirm truly different is not just the science; it is that this capability is now clinically accessible. That is a fundamentally different standard of care.”
In BillionToOne’s clinical validation, Unity Confirm demonstrated 100% concordance with known fetal outcomes and invasive diagnostic results across 16 of 16 samples. The data will be presented at ACOG 2026 in Washington, D.C. The company is now enrolling in a 1,000-patient prospective study measuring concordance with invasive diagnostic testing. Unity Confirm will be available beginning May 28 for providers using Unity Aneuploidy Screen, covering trisomy 21, trisomy 18, trisomy 13, 22q11.2 microdeletion, and sex chromosome aneuploidies.
