Datameds AI Subsidiary Helomics Receives Medicaid Coverage Determination In Gynecologic Cancers For The ChemoFx Assay In Gynecologic Cancers

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 PolicyPolicy Number: HUM-SC-2240-003Effective 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; ORDuring initial biopsy or surgery; ORRecurrent cancer; ORTreatment-refractory; ORUnable 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.