NeXT Personal® — an ultrasensitive, tumor-informed minimal residual disease (MRD) test developed by Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology has been approved for Medicare coverage for recurrence monitoring in patients with early-stage breast cancer. This decision marks a major step forward in providing physicians and patients access to one of the most advanced tools for cancer surveillance.
A New Era in Breast Cancer Surveillance
Under this new decision, Medicare beneficiaries with Stage II and III breast cancer, including all three major subtypes (HR+/HER2–, HER2+, and triple-negative breast cancer (TNBC)) are now eligible for NeXT Personal testing for up to six years following treatment.
This coverage opens the door to earlier detection of recurrence, allowing oncologists to monitor disease progression with unprecedented sensitivity through circulating tumor DNA (ctDNA) analysis.
Clinical Validation and Impact
A pivotal study published earlier this year in the Annals of Oncology demonstrated the exceptional performance of NeXT Personal. The assay successfully detected 100% of patients who later experienced recurrence, identifying disease a median of 15 months earlier and up to five years earlier than standard radiographic imaging.
Importantly, patients who consistently tested negative for MRD using NeXT Personal remained disease-free throughout the study, underscoring the test’s strong negative predictive value.
Expert Perspectives
“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 Dr. Richard Chen, Chief Medical Officer and Executive Vice President of R&D at Personalis. “Our test can detect breast cancer recurrence earlier and provide additional reassurance with negative test results.”
Chris Hall, Chief Executive Officer of Personalis, emphasized the broader implications:
“This is a major achievement for Personalis and an important step forward for the breast cancer community. Medicare coverage validates our technology and empowers clinicians with a new tool for early detection and long-term management.”
Transforming Precision Oncology
Personalis has been at the forefront of developing personalized genomic assays that guide cancer management from diagnosis through survivorship. By integrating tumor-and-normal profiling with proprietary algorithms, NeXT Personal delivers unparalleled sensitivity capable of identifying minuscule traces of ctDNA associated with disease recurrence.
With Medicare’s support, the NeXT Personal test is poised to redefine standard surveillance protocols for breast cancer, enabling more proactive and personalized follow-up care.
About Personalis, Inc.
Based in Fremont, California, Personalis, Inc. is advancing precision oncology through next-generation genomic testing. The company’s assays are designed to detect minimal residual disease (MRD), monitor cancer recurrence, and inform treatment selection using ultra-comprehensive genomic profiling.
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Written by Nare Hovhannisyan, MD