Astrin Biosciences Launches Certitude™ Breast, the First Non-Imaging Breast Cancer Detection Test

Astrin to present early findings of groundbreaking blood-based test at San Antonio Breast Cancer Symposium

Available in early 2026, Certitude will revolutionize breast cancer screening for millions of women

ST. PAUL, Minn., Dec. 3, 2025 /PRNewswire/ -- Astrin Biosciences, a cancer intelligence company transforming how cancer is detected and treated through deep proteomics and AI, announced the launch of Certitude™, the first-of-its-kind, non-imaging, blood-based early cancer detection test. Results from the latest study will be presented at the upcoming San Antonio Breast Cancer Symposium (SABCS), taking place December 10–14, 2025.

The company's study, titled "Deep Proteomics and AI Classifier for Early Breast Cancer Detection," will be featured on Thursday, December 11. Astrin will also be showcasing Certitude at booth #1328 during the conference.

In a study of 1,242 women, Certitude achieved 92% sensitivity at 93% specificity across breast cancer stages and subtypes. With a negative predictive value of >99.9%, Certitude is expected to reduce unnecessary imaging and biopsies that lead to overtreatment.

"These results reinforce the promise of combining deep proteomics with AI to transform how breast cancer is detected," said Justin M. Drake, PhD, lead author of the study and Chief Science Officer at Astrin. "By identifying disease signals at the earliest stages, we can help more women benefit from timely intervention and improved outcomes."

While mammography has enabled breast cancer to be diagnosed at an early stage in a large percentage of patients, in the almost 50% of women with dense breast tissue, current imaging options for early and accurate detection of breast cancer have been limited. Astrin's findings support the potential of deep proteomic profiling to offer a supplement to mammograms, detecting specific signatures of cancer in women with dense breast tissue far earlier than visible on imaging or in circulating tumor DNA.

"I've seen firsthand how far screening has come — and where gaps remain. Mammography remains our most powerful population-level screening tool, but it is not perfect — particularly for the many women with dense breasts," said Dr. Ben H. Park, a prominent breast cancer physician-scientist, thought leader for breast cancer research, and Scientific Advisor to Astrin. "This advancement represents one of the most meaningful advances in breast cancer detection in decades. A blood-based test that can identify molecular signals of cancer before they're visible on imaging has the potential to fundamentally reshape the breast cancer screening paradigm."

"For women with dense breasts, traditional supplemental imaging often leads to false positives, repeat scans, and biopsies that ultimately come back negative — creating tremendous anxiety and unnecessary cost," said Dr. Barbara Levy, Chief Medical Officer at Visana Health, Clinical Professor at George Washington University and UC San Diego Health, and Scientific Advisor to Astrin. "Certitude brings an important new tool to clinicians — one that can reveal early signs of cancer without subjecting women to the cascade of follow-up tests. This is a meaningful step toward more patient-centered screening."

"Following the FDA's September 2024 rule mandating the inclusion of breast density in mammogram reports, women have been left wondering how they can ensure that they are being screened properly," said Jayant Parthasarathy, CEO of Astrin. "Astrin's mission is to make early detection simple, accurate, and accessible for every woman. The launch of Certitude represents a major milestone in our mission."

The Certitude supplemental screening test will be available in the U.S. in early 2026 by prescription only.

SABCS Presentation Details
Session: Liquid Biomarkers in Breast Cancer—Driving Precision Medicine
Title: Deep Proteomics and AI Classifier for Early Breast Cancer Detection
Date & Time: Thursday, December 11, 2025 | 7:00–8:30 AM CST
Location: San Antonio Breast Cancer Symposium, San Antonio, TX
Presenter: Justin M. Drake, PhD, Astrin Biosciences, St. Paul, MN

About Astrin Biosciences
Astrin is a cancer intelligence company built to push the boundaries of technology that accelerate early detection and advance cancer care. Its non-invasive, accessible cancer tests analyze the early signals in over 9,000 proteins to reveal what most blood tests miss: the earliest molecular signals of cancer development. For more information, visit astrinbio.com.

Contact:
Kayli Watson
120/80 MKTG for Astrin Biosciences
[email protected]

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SOURCE Astrin Biosciences