Business Context and Reporting Period
Company: Personalis, Inc.
Filing Type: Form 8-K (Current Report)
Date of Report: November 7, 2025
Event: Item 8.01 Other Events – Medicare Coverage Determination
Key Financial Metrics
This filing is a current report regarding a regulatory milestone and does not contain audited financial statements, revenue figures, profit data, cash flow, margins, debt levels, or liquidity metrics.
Material Changes and Regulatory Milestones
On November 7, 2025, Personalis, Inc. announced that its ultrasensitive NeXT Personal test received Medicare coverage for post-treatment surveillance of cancer recurrence in patients with stage II and III breast cancer. Key details include:
- Effective Date: Retroactive to October 7, 2025.
- Reimbursement Rates:
- NeXT Personal Dx Breast MRD Recurrence Monitoring Test: $3,878
- NeXT Personal Single Plasma Test: $1,158
- Coverage Terms:
- NeXT Personal Single Plasma Test: Available for up to six years post-treatment.
- NeXT Personal Dx Breast MRD Recurrence Monitoring Test: Available once per cancer diagnosis.
Guidance, Outlook, and Risks
The filing does not provide updated financial guidance, management commentary on future performance, or specific risk factors beyond the context of the coverage determination. The primary focus is the commercialization opportunity created by the Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostics Program decision.
Investor Verification Checklist
- Verify the specific CPT codes associated with the $3,878 and $1,158 reimbursement rates.
- Confirm the eligibility criteria for "stage II and III breast cancer" patients under the new coverage.
- Assess the potential volume impact of the "once per diagnosis" limitation on the NeXT Personal Dx Breast MRD Recurrence Monitoring Test.
- Review subsequent filings for any updates on adoption rates or revenue recognition related to this coverage.