#USA #Breast Cancer #Saint Paul #Astrin Biosciences #Certitude™

Astrin Biosciences Launches Certitude™: A New Era in Breast Cancer Detection

Astrin Biosciences, a pioneering company in cancer intelligence, has recently unveiled Certitude™, a groundbreaking non-imaging blood test aimed at early breast cancer detection. This revolutionary test is designed to provide accurate results without the need for traditional imaging techniques, marking a significant advancement in cancer screening.

Scheduled to debut in early 2026, Certitude™ is set to change the way millions of women undergo breast cancer screening. The launch coincides with the company's presentation of its preliminary findings at the upcoming San Antonio Breast Cancer Symposium (SABCS), where a significant study titled "Deep Proteomics and AI Classifier for Early Breast Cancer Detection" will be featured.

Study Results and Implications

In a study encompassing 1,242 women, the Certitude™ test demonstrated remarkable efficacy with a sensitivity of 92% and a specificity of 93% across various stages and subtypes of breast cancer. With an exceptional negative predictive value exceeding 99.9%, this innovative test aims to reduce the dependency on invasive imaging and unnecessary biopsies, ultimately decreasing the rates of overtreatment among patients.

Dr. Justin M. Drake, the Chief Science Officer at Astrin and lead author of the study, expressed confidence in the test's potential. "These findings affirm the transformative potential of merging deep proteomics with artificial intelligence in breast cancer detection. By capturing disease indicators at the earliest possible stage, we can facilitate timely interventions and enhance patient outcomes," he noted.

While mammography has played a crucial role in early-stage detection for many women, approximately 50% of those with dense breast tissue find current imaging methods inadequate. Astrin's innovative approach leverages deep proteomic profiling to detect specific cancer signatures earlier than conventional imaging methods or circulating tumor DNA tests.

Expert Insights

Notable figures in the field have emphasized the significance of this development. Dr. Ben H. Park, a distinguished breast cancer physician-scientist and scientific advisor for Astrin, remarked, "This advancement represents one of the most meaningful breakthroughs in breast cancer detection in decades. A blood-based test that can pinpoint molecular signals of cancer before they become visible on imaging will fundamentally reshape our breast cancer screening framework."

Dr. Barbara Levy, Chief Medical Officer at Visana Health, also highlighted the potential impact on patient anxiety and healthcare costs. "Certitude™ provides an invaluable tool for healthcare providers, enabling them to detect early signs of cancer without subjecting women to a series of follow-up tests that often lead to undue stress and expenses," she stated.

The Future of Breast Cancer Screening

This initiative becomes even more relevant in light of the FDA's recent rule mandating the inclusion of breast density information in mammogram reports. Many women have been left uncertain about ensuring their screening is adequate, a gap that Astrin aims to fill. CEO Jayant Parthasarathy emphasized the company's commitment to making early detection straightforward, precise, and accessible for all women. "The introduction of Certitude™ is a landmark achievement in our mission to improve breast cancer screening," he concluded.

Available by prescription only, the Certitude™ supplemental screening test is set to launch in the U.S. in early 2026. This promising development heralds a new era in breast cancer detection, providing hope for effective screening tailored to women's diverse needs and challenges.

Upcoming Presentation Details at SABCS

• - 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 Biosciences is dedicated to pushing the limits of technology to accelerate early cancer detection and improve cancer care. Utilizing advanced, non-invasive cancer tests that analyze over 9,000 proteins, the company aims to identify molecular signals of cancer development that most other blood tests may overlook. For additional information, please visit astrinbio.com.