What's Happening?
Exact Sciences Corp., in collaboration with the NSABP Foundation and the German Breast Group, has presented the first clinical study results of its Oncodetect® molecular residual disease (MRD) test at the San Antonio Breast Cancer Symposium (SABCS). The
study, part of the NSABP B-59 substudy, focused on early triple-negative breast cancer (TNBC), a particularly aggressive subtype. The findings indicate that the Oncodetect test can effectively predict distant recurrence following surgery. The study analyzed 147 patients and found that post-surgical detection of circulating tumor DNA (ctDNA) was strongly linked to a higher risk of distant recurrence. Patients who were ctDNA-positive after neoadjuvant therapy and surgery had a significantly higher risk of recurrence compared to those who were ctDNA-negative. The results underscore the test's potential in guiding post-surgical treatment decisions, with Exact Sciences planning to submit the data for peer-reviewed publication and Medicare coverage.
Why It's Important?
The introduction of the Oncodetect test represents a significant advancement in the management of triple-negative breast cancer, which is known for its aggressive nature and limited treatment options. By accurately predicting the risk of recurrence, the test can help healthcare providers make more informed decisions regarding post-surgical treatments, potentially improving patient outcomes. This development could lead to more personalized treatment plans, reducing the likelihood of recurrence and improving survival rates. The test's ability to identify patients at higher risk of recurrence could also influence the allocation of healthcare resources, ensuring that high-risk patients receive the necessary follow-up care and interventions.
What's Next?
Exact Sciences plans to submit the study data to a peer-reviewed journal and seek Medicare coverage for the Oncodetect test. The company is also collaborating on a large prospective registry trial, NSABP B-64, which will enroll 1,800 participants across all breast cancer subtypes. These efforts aim to further validate the test's efficacy and expand its clinical application. The results of these studies could influence future guidelines for the management of triple-negative breast cancer, potentially leading to broader adoption of ctDNA testing in clinical practice.
