Certitude™ Breast Cancer Screening Blood Test Now Available to 75 Million Women through OpenLoop Health

Astrin Biosciences' blood-based supplemental screening test expands access nationwide, offering a new tool for more high-risk women

SAINT PAUL, Minn., Sept. 29, 2026 /PRNewswire/ -- Astrin Biosciences, a cancer intelligence company transforming how cancer is detected and treated through deep proteomics and AI, today announced that the Certitude™ test, its first-of-its-kind, non-imaging blood test for early breast cancer detection, is now available to eligible women across 48 states. The expansion, made possible through a new distribution partnership with OpenLoop Health, means women in the U.S. now can access Certitude through an easy-to-use digital platform.

Nearly half of all women are classified as having dense breast tissue — a factor that both raises breast cancer risk and makes traditional imaging less effective at catching cancer early. Until now, many of these women have had limited additional options beyond supplemental imaging, which can be costly, time-consuming, and inconsistently accessible depending on where they live. Certitude fills a longstanding void by detecting early signals of cancer that imaging may miss.

"As a physician, I frequently discuss with patients who have dense breast tissue that while their mammogram is normal, dense tissue can make cancers more difficult to see on imaging," said Dr. Tanya Gupta, Medical Director, Astrin Biosciences. "Certitude provides another data point from a simple blood sample that may help patients and their physicians better understand their individual risk. Offering Certitude through telehealth has the potential to make this additional information more accessible to women and their physicians."

"For too long, geography and fragmented access have stood between women and the comprehensive screening they deserve," said Jayant Parthasarathy, CEO of Astrin Biosciences. "Partnering with OpenLoop allows us to meet women wherever they are with an easy, trusted path to earlier detection. A simple blood draw, supported by physician-led telehealth, transforms what has often been an anxious, uncertain journey into one of confidence and trust. Today's milestone ensures that the peace of mind of earlier detection is finally accessible to millions more women across the country."

"Access to care shouldn't depend on your zip code. That's the problem we built OpenLoop to solve," said Jon Lensing, CEO and Co-Founder of OpenLoop Health. "Certitude is a meaningful new tool that will enable more women to get answers without waiting for the right specialist to be nearby."

Certitude uses Astrin's proprietary deep proteomic platform, analyzing thousands of proteins from a small blood sample to identify early molecular signals associated with breast cancer. In a validation study of 1,242 women, the test demonstrated 92% sensitivity and 93% specificity across breast cancer stages and subtypes, with a negative predictive value greater than 99.9%.¹

To check for eligibility and order the test, visit www.certitudetest.com.

Women in New York and Hawaii can also check medical eligibility to see if Certitude is right for them and then join the waitlist to be notified when Certitude is available in their state.

About Astrin Biosciences

Astrin Biosciences is a biotechnology company based in Saint Paul, MN, dedicated to revolutionizing cancer diagnostics through deep proteome profiling. By combining advanced mass spectrometry with proprietary machine learning algorithms, Astrin is developing highly sensitive, non-invasive tests to detect cancer at its earliest stages, with a mission to end cancer as we know it. Astrin Biosciences Laboratories is accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing. For more information, visit astrinbio.com.

Media Contact
Steven Cooper on behalf of Astrin Biosciences
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SOURCE Astrin Biosciences