AccuStem moves MSC microRNA lung test into Medicare review queue

Rhea-AI Filing Summary

AccuStem Sciences Inc. (ACUT) reports a key administrative step toward Medicare reimbursement for its MSC test (MicroRNA Signature Classifier), a blood-based assay that helps assess lung cancer risk in patients eligible for low-dose CT screening or with indeterminate pulmonary nodules. The MSC test analyzes 24 circulating microRNAs in plasma to classify nodules as Low or High Risk for malignancy, which may help clinicians avoid unnecessary invasive procedures for benign nodules and focus follow-up on higher-risk patients. The company has submitted an application for a local coverage determination to Novitas Solutions, a Medicare Administrative Contractor for the JL region, and Novitas has determined that the application is complete and valid and will now enter the review queue.

Insights

Healthcare reimbursement and diagnostics analyst

AccuStem advances its MSC lung cancer test into the Medicare coverage review queue, but no coverage decision has been made.

AccuStem is pursuing Medicare reimbursement for its MSC test, a blood-based assay that uses 24 circulating microRNAs to classify lung nodules as Low or High Risk for malignancy. The test is aimed at people who qualify for low-dose CT lung cancer screening or who have indeterminate pulmonary nodules detected via imaging, where better risk stratification can influence decisions about biopsies or surgery.

The company has submitted a local coverage determination application to Novitas Solutions, the Medicare Administrative Contractor for the JL region covering several Mid-Atlantic jurisdictions. Novitas has deemed the application complete and valid, placing it into the review queue. This step is procedural rather than outcome-driven; it signals that the evaluation process is formally underway, but the text does not indicate timing, likelihood, or terms of any potential coverage decision.

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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 26, 2025

AccuStem Sciences Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware		000-56257		87-3774438
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

5 Penn Plaza, 19th Floor, #1954 New York, NY		10001
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: 00 44 2074952379

(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 Instruction 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: None

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.

Accustem Sciences Inc.’s (the “Company”) MSC test (MicroRNA Signature Classifier) is a non-invasive blood-based assay designed to assess the risk of lung cancer in people who qualify for low-dose computed tomography (LDCT) screening or have an indeterminate pulmonary nodule detected via imaging. It analyzes a panel of 24 circulating microRNAs (miRNAs) in plasma to classify nodules as Low or High Risk for malignancy. This helps clinicians more accurately understand a patient’s cancer risk, potentially reducing unnecessary invasive procedures (e.g., biopsies or surgery) for benign nodules while prioritizing those at higher risk for further evaluation.

In order to establish reimbursement for the MSC test, the Company has submitted an application for a local coverage determination with Novitas Solutions (“Novitas”), a Medicare Administrative Contractor (MAC) for the Centers for Medicare & Medicaid Services (CMS) for the JL region, which includes the District of Columbia, Delaware, Maryland, New Jersey and Pennsylvania. As part of this submission process Novitas has informed the Company that it has determined that the application is complete and valid and will now enter the review queue.

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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.

	ACCUSTEM SCIENCES INC.
Date: November 26, 2025	By:	/s/ Wendy Blosser
		Wendy Blosser
		Chief Executive Officer

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FAQ

What is AccuStem Sciences (ACUT) announcing in this 8-K?

AccuStem Sciences reports that its application for a local coverage determination for the MSC test has been accepted as complete and valid by Novitas Solutions and has now entered the review queue.

What is AccuStems MSC test and what does it measure?

The MSC test (MicroRNA Signature Classifier) is a non-invasive blood-based assay that analyzes a panel of 24 circulating microRNAs in plasma to classify lung nodules as Low or High Risk for malignancy.

Which patients is the MSC test intended to help?

The MSC test is designed for people who qualify for low-dose CT lung cancer screening or who have an indeterminate pulmonary nodule detected via imaging, helping clinicians better understand their risk of lung cancer.

How could the MSC test affect clinical decisions for lung nodules?

By classifying nodules as Low or High Risk for malignancy, the MSC test may help reduce unnecessary invasive procedures such as biopsies or surgery for benign nodules, while prioritizing higher-risk patients for further evaluation.

What is Novitas Solutions and what role does it play for AccuStem (ACUT)?

Novitas Solutions is a Medicare Administrative Contractor for the Centers for Medicare & Medicaid Services covering the JL region, including the District of Columbia, Delaware, Maryland, New Jersey and Pennsylvania, and it is reviewing AccuStems local coverage determination application for the MSC test.

Has Medicare coverage been granted for AccuStems MSC test?

No. The information states that Novitas has found the application complete and valid and that it will now enter the review queue; it does not state that coverage has been granted.