Personalis Medicare expansion for NeXT Personal test

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

Rhea-AI Filing Summary

Personalis, Inc. reported that the Centers for Medicare & Medicaid Services Molecular Diagnostics Program expanded Medicare coverage for its ultrasensitive NeXT Personal test. As of May 19, 2026, coverage now includes monitoring response to neoadjuvant therapy in patients with Stage II–III triple‑negative or HER2‑positive breast cancer.

Positive

• Medicare coverage expansion for NeXT Personal: CMS Molecular Diagnostics Program broadened Medicare coverage to include monitoring response to neoadjuvant therapy in Stage II–III triple‑negative and HER2‑positive breast cancer, potentially supporting wider clinical use of the test.

Negative

• None.

Insights

Healthcare reimbursement analyst

Medicare now covers broader clinical use of Personalis' NeXT Personal test in specific breast cancers.

The update states that, on May 19, 2026, the CMS Molecular Diagnostics Program expanded Medicare coverage for NeXT Personal. Coverage now includes using the test to monitor treatment response to neoadjuvant therapy in Stage II–III triple‑negative and HER2‑positive breast cancer.

This kind of coverage expansion can meaningfully affect test adoption because Medicare often influences clinical practice and reimbursement decisions. The new indication is focused on higher‑risk breast cancer patients receiving neoadjuvant therapy, where sensitive response monitoring can be clinically important.

Future company disclosures may quantify how this broader coverage affects NeXT Personal testing volumes and related revenue, especially within the Stage II–III triple‑negative and HER2‑positive breast cancer populations covered from May 19, 2026 onward.

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

Medicare coverage expansion date: May 19, 2026 Cancer stage covered: Stage II–III

2 metrics

Medicare coverage expansion date May 19, 2026 Date CMS Molecular Diagnostics Program expanded NeXT Personal coverage

Cancer stage covered Stage II–III Triple‑negative and HER2‑positive breast cancer under expanded Medicare use

Key Terms

NeXT Personal, Molecular Diagnostics Program, neoadjuvant therapy, Triple-Negative Breast Cancer, +1 more

5 terms

NeXT Personal medical

"expanded Medicare coverage for Personalis, Inc.’s ultrasensitive NeXT Personal® test"

Molecular Diagnostics Program regulatory

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

neoadjuvant therapy medical

"include monitoring treatment response to neoadjuvant therapy (NAT)"

Neoadjuvant therapy is medicine given before the main treatment—usually drugs, radiation, or both—aimed at shrinking a tumor or improving surgical outcomes. For investors it signals a strategic step in a drug’s development and commercial path: successful neoadjuvant results can make a treatment easier to use, expand its approved indications, and increase market value much like priming soil before planting improves the eventual harvest.

Triple-Negative Breast Cancer medical

"patients diagnosed with Stage II-III Triple-Negative Breast Cancer (TNBC)"

Triple-negative breast cancer is a type of breast cancer that lacks three common markers used to identify and treat the disease effectively. Because it doesn’t respond to some targeted therapies, it can be more difficult to treat and may have a more aggressive progression. This impacts the development of new treatments and can influence the outlook for healthcare companies involved in cancer research and pharmaceuticals.

HER2-positive (HER2+) medical

"or HER2-positive (HER2+) breast cancer"

FAQ

What did Personalis (PSNL) announce regarding Medicare coverage?

Personalis announced that CMS’s Molecular Diagnostics Program expanded Medicare coverage for its NeXT Personal test. The expansion allows use of the test to monitor response to neoadjuvant therapy in certain Stage II–III breast cancer patients, potentially increasing access for eligible Medicare beneficiaries.

When was Medicare coverage for NeXT Personal expanded for Personalis (PSNL)?

Medicare coverage for NeXT Personal was expanded effective May 19, 2026. On that date, CMS’s Molecular Diagnostics Program added coverage for monitoring treatment response to neoadjuvant therapy in Stage II–III triple‑negative and HER2‑positive breast cancer patients using the test.

Which patients are now covered for Personalis (PSNL) NeXT Personal testing?

Coverage now includes patients diagnosed with Stage II–III triple‑negative breast cancer or HER2‑positive breast cancer. For these patients, NeXT Personal can be used to monitor treatment response to neoadjuvant therapy under the expanded Medicare coverage from May 19, 2026.

What is NeXT Personal in the Personalis (PSNL) 8-K disclosure?

NeXT Personal is described as an ultrasensitive test developed by Personalis. CMS’s Molecular Diagnostics Program expanded Medicare coverage so this test can be used to monitor how patients with certain Stage II–III breast cancers respond to neoadjuvant therapy, enhancing reimbursed clinical utility.

Which program within CMS expanded coverage for Personalis (PSNL) NeXT Personal?

The expansion came from the Centers for Medicare & Medicaid Services Molecular Diagnostics Program. This program extended Medicare coverage so NeXT Personal may be used to monitor response to neoadjuvant therapy in eligible Stage II–III triple‑negative and HER2‑positive breast cancer patients.

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

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Accepted by SEC EDGAR 05/20/2026 - 04:04 PM Learn about SEC filing dates

0001527753false00015277532026-05-192026-05-19

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 19, 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 May19, 2026, the Centers for Medicare & Medicaid Services Molecular Diagnostics Program expanded Medicare coverage for Personalis, Inc.’s ultrasensitive NeXT Personal® test to include monitoring treatment response to neoadjuvant therapy (NAT) in patients diagnosed with Stage II-III Triple-Negative Breast Cancer (TNBC) or HER2-positive (HER2+) breast cancer.

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 20, 2026		Personalis, Inc.
		By:	/s/ Aaron Tachibana
			Aaron Tachibana
			Chief Financial Officer and Chief Operating Officer

Filing Exhibits & Attachments

1 document

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