Personalis, Inc., a leader in precision oncology genomics, announced that Medicare has granted coverage for its ultrasensitive NeXT Personal® test to monitor breast cancer recurrence. The development marks a major advancement in post-treatment cancer surveillance, providing patients and clinicians with a highly sensitive tool for early detection.
Medicare beneficiaries diagnosed with stage II and III breast cancer—including HR+/HER2-, HER2+, and triple-negative breast cancer (TNBC)—will now be eligible for NeXT Personal testing for up to six years during the surveillance period.
"This coverage allows us to expand access to the NeXT Personal test, supporting breast cancer patients who often live with the constant worry of cancer recurrence after treatment," said Richard Chen, CMO and EVP of R&D at Personalis. "Our NeXT Personal test has the potential to help patients by detecting breast cancer recurrence earlier and giving them additional reassurance with negative test results."
A recent Annals of Oncology study involving TNBC, HER2+, and HR+ breast cancer patients highlighted the test’s ability to detect extremely small traces of recurrent disease through a blood sample. NeXT Personal identified 100% of recurrence cases a median of ~15 months—and up to ~5 years—before standard radiographic imaging. Notably, all patients who consistently tested negative remained disease-free throughout the study.
"This is a major achievement for Personalis and, more importantly, it allows us to better serve the breast cancer community," said Chris Hall, CEO of Personalis. "We have pioneered the ultrasensitive MRD testing market to address a critical unmet need in oncology. This Medicare coverage is a powerful validation of our technology and an important step forward for patients, giving them and their doctors a new tool for detecting cancer in their ongoing fight against breast cancer. Personalis remains committed to driving a new paradigm for cancer management through breakthrough personalized testing that guides care from diagnosis through the entire patient journey."
Also Read