Cerenome (Nasdaq: CNSY) secured a national in-network agreement with Aetna for CNSide diagnostic tests, effective November 1, 2026.
The agreement, entered into by wholly owned subsidiary CNSide Diagnostics, establishes contracted reimbursement for cerebrospinal fluid tumor cell counting and molecular profiling tests for solid tumors and hematologic malignancies involving the central nervous system. It is the first national CNSide payer agreement covering both test categories. Aetna adds approximately 26 million medical members, bringing CNSide’s contracted payer footprint to approximately 190 million covered lives. Cerenome intends to pursue similar arrangements across its payer base.
Cerenome (CNSY) completed enrollment in its Phase 2 ReSPECT-GBM trial evaluating REYOBIQ in adults with recurrent glioblastoma, a brain cancer. Enrollment closed with 32 patients treated at the recommended dose, versus 34 planned. Following statistical review, the company determined this was sufficient for final analysis with minimal effect on statistical power. Cerenome expects topline data in mid-2027, followed by an FDA meeting to discuss next steps.
The multicenter, open-label trial evaluates a single administration delivered directly into the tumor. Previously reported interim results in the first 15 patients showed median overall survival of 13 months, versus approximately 8 months historically reported for bevacizumab alone. Across Phase 1 and Phase 2, most treatment-related adverse events were Grade 1 or 2; there were no treatment-related deaths or discontinuations due to serious adverse reactions.
Cerenome (CNSY) will present interim data from its ReSPECT-LMM multidose study of REYOBIQ at the SNO meeting on November 13, 2026. The poster will cover the first ten patients, including safety, radiation dose measurements, cerebrospinal fluid tumor cell counts and individual treatment courses.
The ongoing open-label, multicenter Phase 1 study evaluates repeated doses in patients with leptomeningeal metastases. Cerenome aims to advance into an FDA-aligned Phase 2 dose randomization study in 2027, supporting potential accelerated approval or a follow-on registrational Phase 3 study. Participating U.S. sites are being added. A company-sponsored symposium on November 14 will discuss diagnosis, patient management, the REYOBIQ program and the forthcoming FORESEE 2.0 study.
Cerenome (CNSY) announced preclinical findings suggesting its investigational drug REYOBIQ combines tumor DNA damage with immune-system effects in ovarian cancer models. In two mouse models, its active agent, rhenium Re186 obisbemeda, was associated with tumor injury and changes in the tumor environment. DNA-damage and cell-death programs activated within 24 hours; immune activation increased and immune-suppressing programs decreased by Day 28.
Combining the agent with anti-PD-1, a treatment that blocks an immune checkpoint, extended median survival to 65 days, longer than control or either agent alone. The combination reduced tumor burden, with brief weight loss and no evidence of substantial added toxicity.
Cerenome (CNSY) secured an in-network agreement through its CNSide Diagnostics subsidiary with Florida Blue, effective October 1, 2026. The agreement establishes contracted reimbursement for CNSide cerebrospinal fluid (CSF) tumor cell enumeration and molecular profile tests for solid tumors and blood cancers involving the central nervous system. It is CNSide’s first payer agreement covering both tumor cell enumeration and molecular profiling.
The agreement adds approximately 6 million covered lives, bringing CNSide’s contracted payer footprint to approximately 164 million commercial and Medicare Advantage covered lives. The CSF Molecular Profile tests are now commercially available.
Cerenome (CNSY) announced two CNSide cerebrospinal fluid molecular profiling tests, available to U.S. health care professionals beginning October 12, 2026.
The tests analyze DNA and RNA for solid tumors and hematologic malignancies, or blood cancers, involving the central nervous system. They extend CNSide testing beyond leptomeningeal metastases to include primary CNS tumors and other cancers involving the CNS. A peer-reviewed study evaluating the underlying approach identified cancer-related molecular findings in 78.4% of 1,391 evaluable specimens; this figure is not a stated diagnostic accuracy rate. The tests can be ordered independently or alongside CNSide Tumor Cell Enumeration when appropriate.
Cerenome (CNSY) reported $1.55 million in unaudited third-quarter 2026 gross payer billings for its wholly owned CNSide Diagnostics subsidiary. The billings covered 222 tests. Gross billings are charges submitted at list prices, not revenue or expected collections; the company expects revenue to be substantially lower and initial cash collections in Q4 2026.
The lead Tumor Cell Enumeration Test has 158 million contracted covered lives. Cerenome targets approximately 200 million covered lives and beneficiaries by early 2027. CNSide received favorable preliminary Medicare pricing for code 0640U, with a January 1, 2027 target effective date.
Cerenome plans additional cerebrospinal fluid tests in Q4 2026 and targets an annualized total-test run rate of at least 1,250. Its approximately $10 million–$12 million annualized gross billing run-rate target uses list prices and assumed orders, not a forecast of revenue, billings or collections.
Cerenome (CNSY) will hold a CNSide business update call and webcast on September 30, 2026.
The event begins at 8:30 a.m. Eastern Time. Management plans to discuss third-party billing, market access, expansion of the commercial team and a broader diagnostic testing portfolio for CNSide, its cerebrospinal fluid diagnostic platform.
Cerenome (CNSY) announced an in-network agreement with Blue Cross Blue Shield of Michigan, expanding CNSide contracted coverage to about 158 million lives.
The BCBSM contract, effective September 1, 2026, covers approximately 5 million commercial and Medicare Advantage members through Blue Cross Blue Shield of Michigan and Blue Care Network. Together with prior contracts, CNSide now has reimbursement coverage representing about 158 million commercial and Medicare Advantage covered lives, which the company describes as continued execution of its national reimbursement strategy.
CNSide’s CSF Tumor Cell Enumeration assay for leptomeningeal metastases has been used in more than 11,000 tests since 2020 at over 120 U.S. cancer institutions, supported by 12 peer‑reviewed publications and evidence from the FORESEE clinical study.
Cerenome (CNSY) announced that its wholly owned subsidiary CNSide Diagnostics has appointed Samantha Fowlkes as Vice President and Head of Commercial Sales, effective with the September 16, 2026 announcement. She will lead the commercial expansion of the CNSide® cerebrospinal fluid–based diagnostics platform, focusing on adoption among oncologists, pathologists, physicians, and health systems.
Fowlkes brings more than 20 years of commercial leadership in oncology diagnostics, precision medicine and laboratory services, most recently as Vice President, U.S. Head of Client Clinical Operations at Caris Life Sciences, with prior roles at Genoptix Medical Laboratory and Laboratory Corporation of America. Cerenome is a CNS oncology company with the CNSide® diagnostics platform and the REYOBIQ™ therapeutic platform, which is being evaluated in clinical trials for leptomeningeal metastases, recurrent glioblastoma and pediatric brain cancers.