Women who meet eligibility criteria in 48 states are now able to obtain a supplemental breast-cancer blood assay via telehealth, thanks to a nationwide distribution agreement between Astrin Biosciences and OpenLoop Health. The partners unveiled the launch of Astrin’s Certitude test, projected currently to serve roughly 75 million women, detecting protein patterns associated with breast cancer as early as Stage 0.
OpenLoop provides the clinical infrastructure, including physician ordering, home or local blood collection, and post-result guidance. Patients submit information online for a licensed provider to review and confirm eligibility. The offering targets women with dense breast tissue or raised breast cancer risk who may need additional screening beyond mammography.
Certitude uses mass spectrometry combined with machine learning to analyze protein signals in blood samples, rather than imaging or circulating tumor DNA. The patient website states eligibility begins at age 40, with no evaluation during pregnancy or for those with autoimmune disorders or personal cancer history outside nonmelanoma skin cancer. As a laboratory-developed test, it has not received FDA clearance or approval.
The test costs $525 for self-pay requests submitted through December 31, 2026, with no current insurance coverage. Women in New York and Hawaii can check eligibility and join waitlists, though the test is unavailable in those states yet.
In June, the company partnered with RxHealing and Tenovi on a pharmacy-driven remote patient monitoring program. Earlier, it raised $15 million in 2023 and launched a nationwide payer network and revenue cycle management service for digital health firms. The Certitude rollout aligns with efforts to connect women’s cancer screening to care beyond traditional clinics, similar to recent at-home cervical screening pilots aimed at improving participation through integrated workflows.
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