[8-K] Personalis, Inc. Reports Material Event
Rhea-AI Filing Summary
Personalis, Inc. announced that the Centers for Medicare & Medicaid Services Molecular Diagnostics Program has revised its Medicare reimbursement rates for the company’s ultrasensitive NeXT Personal® test used to monitor cancer recurrence in stage II and III breast cancer patients. Effective December 1, 2025, the NeXT Personal Dx Breast MRD Recurrence Monitoring Test will be reimbursed at $4,266 and the NeXT Personal Single Plasma Test at $1,164. Medicare will cover the Dx Breast MRD Recurrence Monitoring Test once per cancer diagnosis, while the Single Plasma Test is covered for up to six years after treatment, shaping how often these tests can be used for long-term patient surveillance.
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Insights
CMS set specific Medicare rates and usage limits for Personalis’ NeXT Personal breast cancer tests.
The disclosure shows that Personalis now has defined Medicare reimbursement for its NeXT Personal® tests used in post-treatment surveillance of stage II and III breast cancer. Effective
Coverage terms also matter for potential test utilization. The Dx Breast MRD Recurrence Monitoring Test is covered once per cancer diagnosis, while the Single Plasma Test can be used for a period of up to six years after treatment. This structure ties revenue potential to both patient volumes and how clinicians choose between a single higher-priced test and repeated plasma tests within that six-year window.
Actual financial impact will depend on adoption of NeXT Personal in the stage II–III breast cancer setting and on future clinical and commercial execution. Investors can later assess how these rates and utilization limits are reflected in revenue trends in periods following
FAQ
What CMS decision did Personalis (PSNL) announce about NeXT Personal?
Personalis reported that the Centers for Medicare & Medicaid Services Molecular Diagnostics Program revised its reimbursement rate determination for Medicare coverage of the company’s NeXT Personal® test, used for post-treatment surveillance of cancer recurrence in patients with stage II and III breast cancer.
What are the new Medicare reimbursement rates for Personalis’ NeXT Personal tests?
Effective December 1, 2025, Medicare reimbursement will be $4,266 for the NeXT Personal Dx Breast MRD Recurrence Monitoring Test and $1,164 for the NeXT Personal Single Plasma Test.
How often is the NeXT Personal Dx Breast MRD Recurrence Monitoring Test covered by Medicare?
Medicare coverage for the NeXT Personal Dx Breast MRD Recurrence Monitoring Test is available once per cancer diagnosis for eligible stage II and III breast cancer patients.
What is the Medicare coverage duration for the NeXT Personal Single Plasma Test from Personalis?
The NeXT Personal Single Plasma Test has Medicare coverage for a period of up to six years post-treatment, allowing ongoing surveillance of cancer recurrence over that timeframe.
When do the new CMS reimbursement rates for Personalis’ NeXT Personal tests take effect?
The revised Medicare reimbursement rates for Personalis’ NeXT Personal tests are effective starting December 1, 2025, as determined by the Centers for Medicare & Medicaid Services Molecular Diagnostics Program.
Which patient group is targeted by Personalis’ NeXT Personal Medicare coverage update?
The coverage update applies to Personalis’ ultrasensitive NeXT Personal tests used for post-treatment surveillance of cancer recurrence in patients with stage II and III breast cancer.
