[8-K] Personalis, Inc. Reports Material Event

Rhea-AI Filing Summary

Personalis (PSNL) announced that its ultrasensitive NeXT Personal tests received Medicare coverage for post‑treatment surveillance of cancer recurrence in stage II and III breast cancer. The determination from the Centers for Medicare & Medicaid Services Molecular Diagnostics Program is effective retroactively as of October 7, 2025.

The NeXT Personal Dx Breast MRD Recurrence Monitoring Test is covered at a reimbursement rate of $3,878 and is available once per cancer diagnosis. The NeXT Personal Single Plasma Test is covered at $1,158 and is available for up to six years post‑treatment. This expands access and establishes defined payment levels for these assays among eligible Medicare patients.

Positive

• Medicare coverage granted for NeXT Personal assays with defined rates: $3,878 (Dx Breast MRD, once per diagnosis) and $1,158 (Single Plasma, up to six years post‑treatment).

Negative

• None.

Insights

Healthcare reimbursement analyst

Medicare coverage sets clear payment and access for PSNL’s tests.

Personalis secured Medicare coverage for its NeXT Personal assays used to monitor recurrence in stage II/III breast cancer. The decision is effective retroactively as of October 7, 2025, providing defined payments of $3,878 for the Dx Breast MRD Recurrence Monitoring Test and $1,158 for the Single Plasma Test.

Coverage mechanics matter: the Single Plasma Test is available for up to six years post‑treatment, while the Dx Breast MRD test is available once per cancer diagnosis. These parameters shape potential test utilization and revenue per patient under Medicare.

Financial impact will depend on test adoption among eligible beneficiaries and ordering patterns under these coverage limits. Subsequent disclosures may quantify volumes and revenue contributions following the October 2025 effective date.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 7, 2025

Personalis, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-38943		27-5411038
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

6600 Dumbarton Circle Fremont, California				94555
(Address of Principal Executive Offices)				(Zip Code)

(650) 752-1300

Registrant’s Telephone Number, Including Area Code

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		PSNL		The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Events.

On November 7, 2025, our ultrasensitive NeXT Personal^® test received Medicare coverage for post-treatment surveillance of cancer recurrence in patients with stage II and III breast cancer. This coverage determination from the Centers for Medicare & Medicaid Services Molecular Diagnostics Program is effective retroactively as of October 7, 2025, at a reimbursement rate of $3,878 for the NeXT Personal Dx Breast MRD Recurrence Monitoring Test and $1,158 for the NeXT Personal Single Plasma Test. Medicare coverage for the NeXT Personal Single Plasma Test is available for a period of up to six years post-treatment. Coverage for the NeXT Personal Dx Breast MRD Recurrence Monitoring Test is available once per cancer diagnosis.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Date: November 10, 2025				Personalis, Inc.
				By:		/s/ Aaron Tachibana
						Aaron Tachibana
						Chief Financial Officer and Chief Operating Officer

FAQ

What did Personalis (PSNL) announce?

Medicare coverage for its NeXT Personal tests used to monitor cancer recurrence in stage II and III breast cancer, effective retroactively as of October 7, 2025.

What are the Medicare reimbursement rates for PSNL’s tests?

The NeXT Personal Dx Breast MRD Recurrence Monitoring Test is reimbursed at $3,878; the NeXT Personal Single Plasma Test is reimbursed at $1,158.

How long is the Single Plasma Test covered for Medicare patients?

Coverage for the NeXT Personal Single Plasma Test is available for up to six years post‑treatment.

How often is the Dx Breast MRD test covered?

Coverage for the NeXT Personal Dx Breast MRD Recurrence Monitoring Test is available once per cancer diagnosis.

Which patients are covered under this decision?

Patients with stage II and III breast cancer for post‑treatment surveillance of recurrence.

Who issued the coverage determination?

The Centers for Medicare & Medicaid Services Molecular Diagnostics Program.