Personalis gains expanded Medicare test coverage

Personalis, Inc. reported that the Centers for Medicare & Medicaid Services Molecular Diagnostics Program has expanded Medicare coverage for its ultrasensitive NeXT Personal® test.

Filing Impact

(Moderate)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Personalis, Inc. reported that the Centers for Medicare & Medicaid Services Molecular Diagnostics Program has expanded Medicare coverage for its ultrasensitive NeXT Personal® test. The expansion now includes use of the test for immunotherapy monitoring in patients with late-stage solid tumors.

This change means NeXT Personal can be covered by Medicare when used to track how late-stage solid tumor patients respond to immunotherapy, potentially broadening clinical use within the Medicare population.

Positive

Medicare coverage expansion for NeXT Personal: CMS’s Molecular Diagnostics Program expanded Medicare coverage on May 12, 2026 to include use of the ultrasensitive NeXT Personal® test for immunotherapy monitoring in patients with late-stage solid tumors, a potentially meaningful reimbursement milestone for this assay.

Negative

None.

Insights

CMS expanded Medicare coverage for Personalis' NeXT Personal test.

The update states that on May 12, 2026, the Centers for Medicare & Medicaid Services Molecular Diagnostics Program expanded Medicare coverage for the NeXT Personal® test. Coverage now includes its use for immunotherapy monitoring in patients with late-stage solid tumors.

This is a regulatory reimbursement development, not a clinical approval. It formally recognizes this testing use case for Medicare beneficiaries. Actual impact will depend on how widely clinicians adopt NeXT Personal for monitoring immunotherapy in eligible late-stage solid tumor patients.

Future company disclosures may detail how frequently the test is used in this setting and whether this coverage expansion influences overall test utilization among Medicare patients with late-stage solid tumors.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Key Figures

CMS coverage expansion date: May 12, 2026 Common Stock par value: $0.0001 per share

2 metrics

CMS coverage expansion date May 12, 2026 Date CMS Molecular Diagnostics Program expanded Medicare coverage for NeXT Personal

Common Stock par value $0.0001 per share Par value of Personalis common stock listed on Nasdaq Global Market

Key Terms

Centers for Medicare & Medicaid Services, Molecular Diagnostics Program, Medicare coverage, immunotherapy monitoring, +1 more

5 terms

Centers for Medicare & Medicaid Services regulatory

"On May12, 2026, the Centers for Medicare & Medicaid Services Molecular Diagnostics Program expanded Medicare coverage"

The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that runs major public health insurance programs and sets rules for what treatments and services are paid for and how much providers receive. Think of it as the rulebook and paymaster for a large portion of the health-care system: its coverage decisions, payment rates, and regulations can quickly change revenues, costs, and market access for hospitals, insurers, drugmakers and medical-device companies, so investors track its actions closely.

Molecular Diagnostics Program regulatory

"the Centers for Medicare & Medicaid Services Molecular Diagnostics Program expanded Medicare coverage"

Medicare coverage financial

"Molecular Diagnostics Program expanded Medicare coverage for our ultrasensitive NeXT Personal"

Medicare coverage is the set of health insurance benefits provided by the U.S. federal Medicare program that pays for hospital care, doctor services, prescription drugs and certain medical supplies for eligible beneficiaries. Investors pay attention because changes in what Medicare will cover, how much it reimburses, or who qualifies can materially affect revenue and pricing for hospitals, drugmakers, medical device manufacturers and insurers—like rewriting the rulebook for a very large, steady customer.

immunotherapy monitoring medical

"to include immunotherapy monitoring for patients with late-stage solid tumors"

late-stage solid tumors medical

"immunotherapy monitoring for patients with late-stage solid tumors"

FAQ

What did Personalis (PSNL) announce regarding Medicare coverage?

Personalis announced that the Centers for Medicare & Medicaid Services Molecular Diagnostics Program expanded Medicare coverage for its NeXT Personal test. The coverage now includes using the test for immunotherapy monitoring in patients with late-stage solid tumors, formalizing reimbursement for this specific clinical use.

Which Personalis test received expanded Medicare coverage?

Medicare coverage was expanded for Personalis’ ultrasensitive NeXT Personal® test. The CMS Molecular Diagnostics Program now covers this assay when it is used for immunotherapy monitoring in patients with late-stage solid tumors, according to the disclosure dated May 12, 2026.

For what clinical use is NeXT Personal now covered by Medicare?

NeXT Personal is now covered by Medicare for immunotherapy monitoring in patients with late-stage solid tumors. This means the test can be reimbursed when used to track how these patients respond to immunotherapy under the CMS Molecular Diagnostics Program framework.

When was the Medicare coverage expansion for Personalis’ NeXT Personal test disclosed?

The coverage expansion was disclosed for May 12, 2026. On that date, the CMS Molecular Diagnostics Program expanded Medicare coverage to include use of the NeXT Personal test for immunotherapy monitoring in late-stage solid tumor patients, as reported in Personalis’ current report.

Does the CMS decision apply to late-stage solid tumor patients only for NeXT Personal?

Yes. The disclosure specifies that Medicare coverage for NeXT Personal now includes immunotherapy monitoring for patients with late-stage solid tumors. The expanded coverage is framed around this particular patient group and use case within the CMS Molecular Diagnostics Program.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 05/13/2026 - 04:03 PM

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): May 12, 2026

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 May12, 2026, the Centers for Medicare & Medicaid Services Molecular Diagnostics Program expanded Medicare coverage for our ultrasensitive NeXT Personal® test to include immunotherapy monitoring for patients with late-stage solid tumors.

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: May 13, 2026	Personalis, Inc.

	By:	/s/ Aaron Tachibana
		Aaron Tachibana
		Chief Financial Officer and Chief Operating Officer

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

1 document

Personalis gains expanded Medicare test coverage