Lead test on track for 200 million covered lives and beneficiaries by early 2027 after CMS meeting
On track to launch expanded CNSide testing menu with multiple tests in Q4 2026
HOUSTON, Sept. 30, 2026 (GLOBE NEWSWIRE) -- Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company") today provided a third quarter 2026 business update for its wholly owned subsidiary, CNSide Diagnostics, LLC, highlighting gross payer billings, progress on Medicare coverage of its Tumor Cell Enumeration Test (TCE Test) and the expansion of the CNSide testing menu.
"Over the past few months, we have built the foundation of a reimbursed diagnostics business including clinical evidence, payer contracts, a dedicated billing code, positive CMS Medicare coverage progress, laboratory accreditation and billing infrastructure," said Russell Bradley, President and General Manager of CNSide Diagnostics. "We are on track to continue that progress across multiple areas of the business for the remainder of the year, and our team is excited about the future of CNSide."
Third Quarter 2026 CNSide Highlights:
- Coverage Expansion: CNSide’s lead test, the TCE Test, now stands at 158 million contracted covered lives and is on track to begin 2027 with approximately 200 million covered lives and beneficiaries
- Medicare Coverage: CNSide received a favorable preliminary CMS pricing decision for CNSide PLA code 0640U with a January 1, 2027 target effective date
- Payer Billing: In Q3 2026, CNSide billed 222 tests representing $1.55 million of unaudited gross billings, with initial cash collections anticipated in Q4 2026
- Total Test Volume: CNSide remains on track to meet or exceed an annualized run rate of 1,250 total tests in Q4 2026
- Cerebrospinal Fluid Test Menu: CNSide is launching the CSF Molecular Profile Test and multiple CNSide Breast Cancer Protein Expression Assays in Q4 2026
- 2026 Annualized Billing Rate: CNSide is on track to achieve an annualized gross billing run rate of approximately $10 million to $12 million in Q4 2026 based on list pricing, an expanded test portfolio, and continued growth in adoption
Management to Host Conference Call and Webcast Today
Management will host a conference call and webcast today at 8:30 a.m. Eastern Time to provide greater detail on CNSide diagnostics and plans for the remainder of the year. A replay will be available following the call in the Investor Relations section of the Company's website at ir.cerenome.com.
Basis of Presentation: Preliminary Results, Gross Billings and Run-Rate Figures
The preliminary third-quarter gross billings figure is based on management's review of claims submitted through September 30, 2026, is subject to completion of financial close procedures and review by the Company's independent registered public accounting firm, and may differ materially from final results. "Gross billings" is an operating metric representing charges for CNSide tests submitted to payers at the Company's list prices; it is not revenue under U.S. GAAP and does not indicate amounts that will be collected. Revenue is recognized under ASC 606 net of contractual allowances and implicit price concessions and is expected to be substantially lower than gross billings. Run-rate figures apply list prices to the Company's 1,250 total annualized test order goal and historical order rates under the platform's prior owner, and assume the CNSide CSF Molecular Profile Test and CNSide Breast Cancer Protein Expression Assays launch as planned and are ordered at those rates. CNSide order rates may differ. Existing CPT codes do not establish coverage or payment for these assays on cerebrospinal fluid. Run-rate figures are not forecasts of revenue, gross billings, or collections for any period.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Cerenome, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases. For more information, visit https://www.cnside-dx.com/.
About Cerenome
Cerenome (Nasdaq: CNSY) is a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence to improve outcomes for patients with central nervous system cancers. The Company's CNSide® Diagnostics platform supports the detection, molecular characterization, and longitudinal monitoring of CNS cancers through cerebrospinal fluid-based testing. Its lead therapeutic platform, REYOBIQ™ (rhenium Re186 obisbemeda), is being evaluated in clinical trials for leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancers. The data & artificial intelligence platform is designed to integrate diagnostic, molecular, imaging, and clinical data into actionable insights that support precision oncology and therapeutic innovation. For more information, visit https://www.cerenome.com.
Forward-Looking Statements
This press release contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. All statements other than statements of historical fact are forward-looking statements and may be identified by terms such as "expect," "potential," "anticipating," "planning," "on track" and similar expressions or the negatives thereof. Such statements are based upon assumptions and assessments made by management in light of their experience and perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding preliminary third-quarter gross billings; the timing and amount of revenue and cash collections; achievement of a 1,250 annualized total test order run rate; annualized gross billings run-rate calculations and the order rates underlying them; the timing of the launches of the CSF Molecular Profile Test and multiple CNSide Breast Cancer Protein Expression Assays; Medicare pricing and its effective date; Medicare and commercial coverage, including the covered-lives target; claim adjudication and reimbursement rates; the timing of revenue guidance; and expectations as to the Company's future performance. Actual results may differ materially due to a variety of risks and uncertainties, including those described in the Company's filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statements, except as required by law.
Investor Contact
CORE IR · [email protected]