A Supplemental Blood Test to Bridge Gaps in Breast Cancer Screening Access

At the San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas, Justin Drake, PhD, discusses the growing need for supplemental breast cancer screening options, particularly for women with dense breasts or those with inconclusive or negative mammograms. He explains that while mammography remains the standard of care, limited sensitivity—especially in dense breast tissue—creates gaps that emerging blood-based technologies may help fill. Drake highlights Astrin Bioscience’s Certitude Breast test as a potential solution, offering a non-imaging, proteomics-driven approach for early detection and improved screening access.

Pharmacy Times: As blood-based cancer screening tools expand, pharmacists are increasingly involved in patient education, test navigation, and addressing disparities. How do you envision pharmacists contributing to the integration of Certitude Breast into screening pathways, especially for underserved populations with limited access to MRI or specialty imaging?

Justin Drake, Ph.D.: So the first half is, you know, as I mentioned, we're providing a supplemental screening option. So we recommend all women to still get their mammograms. So we're not replacing mammograms as of today. But if you do have an inconclusive mammogram, or if you're a woman with dense breasts, or if you have a negative mammogram and you're a woman with dense breasts, then this supplemental screening option could be a great option for you. And again, it's to help to rule out whether further intervention is necessary, such as an ultrasound or an MRI.

Now, on the other half, the back half of that question is a really interesting question. So while we don't say we're not going to replace a mammogram, there's about over 10% of the counties in the United States that have 0 or 1 mammogram facility in those counties. That represents millions of women, over 10 million women, that really don't have easy access to a screening option. So what we could provide in that particular context is a way to give them an easy screening option via a blood test to help rule out cancer in their scenario.

Pharmacy Times: Certitude Breast is being positioned as the first non-imaging blood test that performs comparably to MRI. What are the next steps in validation, real-world evidence generation, or regulatory milestones necessary before clinicians can confidently use this test in annual screening programs?

Justin Drake, Ph.D.: Yeah, great question. So, you know, we're just getting started here. Things are very exciting. We have a paper in press where we did a case-controlled study of 300 women. And we have a paper that we're presenting here at San Antonio on a biobank of 1250 women, showing, again, very high sensitivity and specificity.

So what's next? So we obviously need to do some prospective trials, all right? So we have a few of those lined up with key partners at the Mayo Clinic and University of Pittsburgh Medical Center, where we're comparing our tests to MRI. We're comparing our tests to contrast-enhanced mammography. And we're also doing a prospective pre-biopsy study where we're collecting both benign and cancerous lesions to ask the performance of our test in a very tough setting, which is trying to rule out women who might have a benign lesion to help eliminate unnecessary biopsies for those women down the road.