DataMEDS SI Announces Helomics Receives Medicaid Coverage Policy For Chemofx(R) Assay In Gynecologic Cancers

Humana's policy provides coverage eligibility for specified gynecologic cancer settings, but ChemoFx is not covered under all its plans.

Rhea-AI Summary

DataMeds AI (NASDAQ:MEDS) announced that subsidiary Helomics received Humana Medicaid coverage for its ChemoFx chemotherapy-response assay in gynecologic cancers. The policy became effective July 22, 2026. ChemoFx tests a patient's live tumor cells to help inform chemotherapy selection and is billed under CPT codes 81535 and 81536.

Members may be eligible for testing during initial biopsy or surgery, for recurrent or treatment-refractory cancer, when recommended treatment cannot be tolerated, or for rare cancers without established treatment guidelines. Coverage does not extend to all Humana plans. Helomics previously invested in laboratory automation. DataMeds said the laboratory is positioned to support additional volume as coverage grows and is preparing data for publication to support label expansion. ChemoFx is a laboratory-developed test without FDA clearance or approval.

3 points · 0 major

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0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointHelomics received Humana Medicaid coverage for ChemoFx in gynecologic cancers, effective July 22, 2026.
• Minor point. Forward-looking: it has not happened yet and may not happen.Helomics previously invested in laboratory automation; DataMeds says the laboratory can support additional volume as coverage grows.
• Minor point. Forward-looking: it has not happened yet and may not happen.DataMeds is preparing data for publication to support ChemoFx label expansion.

Negative

• Minor pointChemoFx coverage does not extend to all Humana plans.
• Minor pointMember eligibility is conditional on specified clinical settings, rather than unrestricted gynecologic cancer testing.

Key Figures

Policy effective date: July 22, 2026 Incremental cost-effectiveness ratio: $6,206 per life-year saved Incremental cost-effectiveness ratio: $2,773 per life-year saved +4 more

Policy effective date

July 22, 2026

Humana Medicaid coverage policy for pharmacogenomics testing

Incremental cost-effectiveness ratio

$6,206 per life-year saved

Recurrent EOC patients treated according to ChemoFx results

Incremental cost-effectiveness ratio

$2,773 per life-year saved

Platinum-sensitive population treated with assay-sensitive therapies

Incremental cost-effectiveness ratio

$2,736 per life-year saved

Platinum-resistant population treated with assay-sensitive therapies

Mean chemotherapy treatment cost

$48,758

Estimated for empirically treated recurrent ovarian cancer patients

Mean chemotherapy treatment cost

$33,187

Estimated for assay-assisted patients; 65% adherence to assay results

Mean chemotherapy treatment cost

$23,986

Estimated for modeled assay-adherent patients; 100% adherence to assay results

Key Terms

pharmacogenomics testing, markov state transition model, incremental cost effectiveness ratio (icer), laboratory-developed test

4 terms

pharmacogenomics testing medical

"Coverage Determination for Pharmacogenomics Testing"

A laboratory test that analyzes a person’s genetic variants to predict how they are likely to respond to specific medicines. It identifies gene variants that affect drug absorption, metabolism, transport or targets (for example enzymes that metabolize drugs) and reports which drugs or doses may be more or less effective or carry higher risk of side effects; tests can examine one gene, a small panel, or many genes. Results indicate increased or decreased likelihoods and guide clinical decisions but do not guarantee a particular response, and different tests and labs may cover different genes or use different result interpretations.

markov state transition model technical

"using a Markov state transition model based on patient characteristics"

A Markov state transition model is a mathematical model that represents a system as a set of discrete states and the probabilities of moving from one state to another over time. It encodes the Markov property — the chance of the next state depends only on the current state and not on the sequence of past states — usually summarized in a transition matrix (or transition rates for continuous time). The model can show likely paths, long‑run (steady‑state) distributions, and absorbing states, but it inherently assumes that history beyond the current state does not affect future transitions, which may limit its realism for processes with memory.

incremental cost effectiveness ratio (icer) medical

"presented an incremental cost effectiveness ratio (ICER) of $6,206"

Incremental cost-effectiveness ratio (ICER) is a summary measure used in health economics that compares the additional cost of one medical intervention to the additional health benefit it delivers versus an alternative. It is calculated as (Cost of intervention A − Cost of comparator B) divided by (Effectiveness of A − Effectiveness of B), where effectiveness is commonly measured in quality-adjusted life years (QALYs) or life-years gained; the result is expressed as cost per unit of health benefit (for example, dollars per QALY). A lower ICER means the extra benefit costs less per unit; special cases include a dominant intervention (lower cost and greater effectiveness) or an ICER based on a negative denominator or numerator, which requires careful interpretation, and the ICER does not by itself determine whether an intervention is acceptable under any particular payer’s threshold or decision rule.

laboratory-developed test regulatory

"is a laboratory-developed test and has not been cleared or approved"

A laboratory-developed test is a diagnostic test that a single clinical laboratory designs, builds and uses in its own facility rather than buying from an outside manufacturer; think of it as a custom recipe made and run in-house for diagnosing disease. Investors care because these tests can be quicker to bring to market and create a revenue stream for labs, but they also carry regulatory and quality-risk differences that can affect demand, reimbursement and legal exposure.

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TAMPA, FL / ACCESS Newswire / October 12, 2026 / DataMeds AI, Inc. (NASDAQ:MEDS) ("DataMeds AI," "DataMEDS SI," "DataMEDS," or the "Company"), a healthcare company vertically integrating its Health IT and physical infrastructure together with its super intelligence platform EinsteinRx^™ and smart contracts platform PharmacyChain^™, today announced that its recently acquired CLIA-certified precision oncology laboratory subsidiary Helomics Corporation has received a Medicaid coverage determination in gynecologic cancers for the ChemoFx^® Assay, a commercially available chemoresponse test that measures how a patient's live tumor cells respond to chemotherapy agents, in gynecologic cancers. Medical Coverage Policies were reviewed by Humana's Medicaid Coverage Policy Adoption (MCPA) Forum, which incorporated the ChemoFx Assay in its Coverage Determination for Pharmacogenomics Testing^[1].

"We are very pleased that Humana has included the ChemoFx Assay in its Medicaid coverage policy for gynecologic cancers," said Gerald E. Commissiong, Interim Co-CEO of DataMEDS. "ChemoFx gives oncologists patient-specific information on how a tumor responds to a range of chemotherapy agents, supported by peer-reviewed^[2] clinical utility data on treatment outcomes based on ChemoFx-enabled therapeutic selection in gynecologic cancers. ChemoFx is billed under dedicated CPT codes 81535 and 81536, and the laboratory is positioned to support additional volume as coverage grow. Helomics previously invested in lab automation to improve commercial readiness."

Mr. Commissiong continued, "The evidence for ChemoFx in gynecologic cancers was reviewed in the 2021 gynecologic cancer peer-reviewed publication on ChemoFx^[3], as well as the 2015 cost savings peer-reviewed publication in^[4]epithelial ovarian cancer (EOC). We believe there is an opportunity to evaluate ChemoFx in additional settings, including difficult-to-treat cancers, and we are preparing data for publication to support label expansion."

Humana Medicaid Medical Coverage Pharmacogenomics Testing Policy

Policy Number: HUM-SC-2240-003

Effective Date: July 22, 2026

"Humana members may be eligible under the Plan for ChemoFx Assay (CPT Codes 81535 and 81536) to determine how cancer cells may respond to chemotherapeutic agents for an individual diagnosed with gynecologic cancer (e.g., cervical, endometrial, fallopian tube, gynecologic sarcoma, ovarian, primary peritoneal) for the following indications:

• Diagnosed with a rare cancer with no established treatment guidelines; OR
• During initial biopsy or surgery; OR
• Recurrent cancer; OR
• Treatment-refractory; OR
• Unable to tolerate recommended treatment."

The ChemoFx Assay is not currently covered under all Humana plans.

Economic Impact in EOC^[5]

ChemoFx is considered to be a cost-effective health care intervention, using a Markov state transition model based on patient characteristics and survival data from a clinical study of ChemoFx in recurrent EOC. ChemoFx presented an incremental cost effectiveness ratio (ICER) of $6,206 per life-year saved (LYS) for patients with recurrent EOC who are treated according to ChemoFx results (compared to similar patients whose treatment decisions were made without ChemoFx). Cost-effectiveness was further demonstrated in both platinum-sensitive and platinum-resistant populations treated with assay-sensitive therapies with ICERs of $2,773 per LYS and $2,736 per LYS, respectively. Furthermore, if the least expensive, sensitive therapy is chosen for treatment, use of ChemoFx has the potential to be cost saving.

The mean costs of chemotherapy treatment for recurrent ovarian cancer were estimated to be $48,758 for empirically treated patients, $33,187 for assay-assisted patients (oncologist's choice of chemotherapy following chemoresponse testing, with 65% adherence to assay results) and $23,986 for assay-adherent patients (modeled group of patients assuming 100% adherence to assay results). According to this study, assay-assisted treatment decisions in recurrent ovarian cancer may result in reduced costs compared to empiric treatment selections.

These results may not reflect current treatment patterns or costs.

The ChemoFx Assay is a laboratory-developed test and has not been cleared or approved by the U.S. Food and Drug Administration.

About Helomics Corporation

Helomics Corporation, a wholly owned subsidiary of DataMeds AI, Inc. (NASDAQ:MEDS), operates a CLIA-certified clinical laboratory in Pittsburgh, Pennsylvania, focused on precision oncology. Its flagship ChemoFx^® Assay tests a patient's live tumor cells against a panel of chemotherapy agents to give oncologists patient-specific information to help inform treatment decisions in gynecologic cancers. ChemoFx is billed under CPT codes 81535 and 81536. Through Predictive Oncology, its innovation division, Helomics combines a large annotated biobanks of tumor samples, from over 130 tumor types, with artificial intelligence and multi-omic data. It uses these to help pharmaceutical and biotechnology partners predict tumor response and speed up oncology drug discovery and development. For more information, visit https://predictive-oncology.com/ .

About DataMeds AI, Inc.

DataMeds SI (NASDAQ:MEDS) is a healthcare company that focuses on the vertical integration of technology, pharmacy, pharmaceutical-adjacent and telemedicine business units through its Health IT platforms to deliver a better experience for consumers and providers. Headquartered in Tampa, Fla., DataMEDS incorporates the super intelligence platform EinsteinRx^™ and blockchain-enabled smart contracts platform PharmacyChain^™ into Tollo Health, LLC's Health Lives Here mobile application, and its Corexa Pharmacy provides pharmacy dispensing and related services, including the distribution of products developed by Tollo Health. The Company's Helomics Corporation subsidiary operates a CLIA-certified laboratory in Pittsburgh offering the ChemoFx^® Assay.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and are not predictions of actual performance. Forward-looking statements include, without limitation, statements regarding the scope, duration and continuation of Humana's Medicaid coverage policy for the ChemoFx Assay; the Company's ability to obtain coverage and reimbursement from other payers, including Medicare and commercial plans; reimbursement rates and collections for CPT codes 81535 and 81536; demand for and adoption of the ChemoFx Assay; the Helomics laboratory's capacity, automation and compliance with CLIA and state requirements, and the regulatory status of laboratory-developed tests; the Company's plans to publish ChemoFx data and the results of any such analyses; the integration of Helomics following its acquisition; the Company's anticipated business strategy, operating plans and growth opportunities; the Company's ability to maintain compliance with Nasdaq listing standards, the development of a proprietary blockchain and the development of provider-network features, the creation of the Health Lives Here pharmacy network, the success of the NFL Alumni Health partnership, the companies' proposed transaction with DataVault AI Inc. (NASDAQ: DVLT), Scilex Holding Company, EOS Holdings and HealthBridge Advisors (controlling shareholder of Tollo Health, LLC); the satisfaction or waiver of closing conditions applicable to any of the foregoing; the receipt of stockholder approval and any other required approvals; the Company's anticipated business strategy, operating plans and growth opportunities; the integration of telemedicine, pharmacy, laboratory, wearable-device, artificial intelligence, blockchain and data-management technologies; the proposed development, commercialization and expansion of EinsteinRx AI, PharmacyChain, Health Lives Here and related platforms; the anticipated growth of the market for Long COVID products and related treatment approaches; the companies' ability to empower patients to access, manage, control or monetize health data; the anticipated benefits of the companies' technology platforms, strategic relationships and business combinations; the Company's capitalization, outstanding securities, lock-up arrangements, public float and registration statements; the Company's ability to maintain compliance with Nasdaq listing standards; and the Company's liquidity, capital resources and ability to fund operations. Actual results may differ materially from those expressed or implied in these forward-looking statements due to a number of risks and uncertainties, including those described under "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to update or revise any forward-looking statements, except as required by law.

DataMeds AI Media Contact

James Lambert, Vice President
Rubenstein Public Relations
Phone: 212.805.3024
Email: jlambert@rubensteinpr.com

DataMeds AI Investor Contact
Investor Relations: IR@datamedsai.com

^[1] https://assets.humana.com/is/content/humana/MCD Pharmacogenomics Testing HUM-SC-2240-003 ed 7.22.26pdf

^[2] https://www.semanticscholar.org/paper/Clinical-Utility-of-a-ChemoFx%C2%AE-Drug-Response-Assay-Walstrom-Stevens/98e740487d5cddbf05c1fcaa02ed017ff7fda00f

^[3] https://www.semanticscholar.org/paper/Clinical-Utility-of-a-ChemoFx%C2%AE-Drug-Response-Assay-Walstrom-Stevens/98e740487d5cddbf05c1fcaa02ed017ff7fda00f

^[4] https://currents.plos.org/genomictests/article/use-of-chemofx-for-identification-of-effective-treatments-in-epithelial-ovarian-cancer/

^[5] https://currents.plos.org/genomictests/article/use-of-chemofx-for-identification-of-effective-treatments-in-epithelial-ovarian-cancer/

SOURCE: DataMEDS AI, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When did Humana Medicaid coverage for DataMeds AI's ChemoFx assay take effect?

The Humana Medicaid pharmacogenomics testing policy covering ChemoFx became effective July 22, 2026. The policy number is HUM-SC-2240-003, and coverage does not apply to all Humana plans.

Which gynecologic cancers are included in Humana's ChemoFx coverage policy?

The policy lists cervical, endometrial, fallopian tube, gynecologic sarcoma, ovarian and primary peritoneal cancers as examples. Members may be eligible during initial biopsy or surgery, for recurrent or treatment-refractory disease, when recommended treatment cannot be tolerated, or for rare cancers without established treatment guidelines.