Astrin Biosciences and OpenLoop Health have announced a distribution partnership to expand access to Certitude, a blood-based breast cancer screening test, across 48 US states. The initiative could reach approximately 75 million women, providing an additional screening option for individuals with dense breast tissue or elevated breast cancer risk.
Certitude is designed to complement mammography rather than replace conventional imaging. The test identifies protein patterns associated with breast cancer, including potential indicators of disease as early as Stage 0.
Astrin's technology combines mass spectrometry with machine learning to analyse protein signals in blood samples. Unlike approaches relying on imaging or circulating tumour DNA, the platform examines protein patterns associated with cancer.
Under the partnership, OpenLoop will provide the clinical infrastructure supporting test delivery, including physician ordering, blood collection and post-result guidance. Patients can submit their information online for review by a licensed healthcare provider, who determines eligibility. Blood samples can subsequently be collected at home or through local collection services.
The test is available to eligible women aged 40 and older. However, Astrin notes that Certitude has not been evaluated in pregnant individuals, patients with autoimmune disorders or those with a personal history of cancer, excluding nonmelanoma skin cancer.
Certitude is classified as a laboratory-developed test and has not received FDA clearance or approval. Insurance coverage is currently unavailable, with Astrin offering an introductory self-pay price of $525 for requests submitted before December 31, 2026. Women in New York and Hawaii can register their interest through a waitlist, although testing remains unavailable in those states.
The partnership follows OpenLoop's broader expansion of its virtual healthcare infrastructure. In June, the company collaborated with RxHealing and Tenovi to introduce a pharmacy-driven remote patient monitoring programme, providing clinical oversight, compliance and billing support.
The rollout also reflects growing efforts to extend women's cancer screening beyond traditional healthcare settings. Similar initiatives include a recent collaboration between Teal Health and UC Davis Health to evaluate at-home cervical screening and its potential to improve screening participation.
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