Cerenome said its CNSide diagnostics division began submitting payer claims during the third quarter of 2026, marking a transition from building reimbursement infrastructure to billing for its cerebrospinal fluid-based cancer diagnostic tests.
President and Chief Executive Officer Marc Hedrick said the company’s diagnostic strategy is focused on central nervous system cancers, including leptomeningeal metastases, or LM. He described CNS cancers as an underserved area of oncology and said the company estimates the CNSide diagnostic opportunity at approximately $2.7 billion for LM alone, with an additional estimated $2.8 billion opportunity across broader CNS workup and brain metastases populations.
Coverage, billing and testing adoption
Bradley said Cerenome completed Medicare enrollment in May and its proprietary reimbursement code became effective July 1. The company expects the Centers for Medicare & Medicaid Services to publish a preliminary payment rate that would take effect Jan. 1, 2027. Traditional Medicare coverage remains subject to a separate decision by Novitas Solutions, the company’s local Medicare contractor in Texas.
The company reported that its laboratory completed 232 CNSide tests during the first half of 2026. Second-quarter test volume increased 64% from the first quarter, and Cerenome expected to finish the third quarter with approximately 203 CNSide tests, up about 41% sequentially. The company said it remains on track for a 1,250-test annualized run rate, or roughly 100 tests per month, during 2026.
CNSide had 43 ordering providers, including 39 physicians, across 24 ordering institutions at the time of the call. Bradley said 15 of the 24 institutions had ordered in at least two separate months and accounted for 97% of commercial test volume during the year. Ten institutions had tested the same patients more than once, which the company said supports the use of its tumor cell enumeration test in patient monitoring.
Expanded testing menu planned
Cerenome plans to launch its CNSide CSF Molecular Profile test on Oct. 12. The test is designed to sequence more than 300 DNA genes and more than 1,600 RNA transcripts from the same spinal fluid sample used for its existing tumor cell enumeration, or TCE, test.
The company also plans to introduce its first CNSide CSF Cellular Biomarker tests at the Society for Neuro-Oncology meeting in Philadelphia in November. The initial protein-expression panel will focus on breast cancer biomarkers, including estrogen receptor, progesterone receptor and HER2.
Bradley said the full planned menu could carry a combined illustrative list price of up to approximately $15,000 per specimen, although reimbursement will depend on payer contracts, coverage and the tests ordered by physicians. He said a comprehensive test menu would likely be used during an initial diagnostic workup, while subsequent monitoring is more likely to rely on tumor cell enumeration.
For the molecular and biomarker offerings, Bradley said the company expects to bill using existing CPT codes rather than the proprietary code used for its TCE test. He cited a reimbursement amount of about $2,900 for the DNA profiling code, while noting that payment would vary according to the tests ordered and applicable reimbursement.
Early commercial metrics and outlook
Chief Financial Officer Andrew Sims said the company had submitted claims representing approximately $1.55 million in unaudited gross billings on 222 performed TCE tests during the quarter to date. He said just under 200 of those tests were performed in the third quarter, with the remainder coming from earlier testing.
Sims said cash collections are expected to lag gross billings, though the company anticipates beginning collections in the fourth quarter. Cerenome’s initial model assumes about $1 million in collections during 2026 and a base target of more than $5 million in 2027, subject to assumptions. The company plans to emphasize gross billings until it develops two to three quarters of billing and collections experience, at which point it expects to provide revenue guidance.
Using its 1,250-test annualized order-rate objective and the planned new tests, Sims said Cerenome estimates an annualized gross-billings run rate of approximately $10 million to $12.5 million as it enters 2027. He emphasized that the figure is an illustrative run-rate calculation, not a revenue, gross-billings or collections forecast.
The company hired Samantha Fowlkes as vice president and head of commercial sales effective Sept. 16. Bradley said the first field representatives are expected to be hired in the fourth quarter, while a new representative typically requires two to three quarters to reach full productivity. Cerenome plans initially to deepen adoption among existing ordering institutions and re-engage cancer centers that have previously ordered CNSide.
Cerenome also said it moved its laboratory to Houston’s Levit Green life-science campus in September and is building a purpose-designed facility with capacity for up to 50,000 tests annually. Sims said a previously announced debt royalty financing with 3i is expected to extend the company’s cash runway into 2028, with access to the remaining financing balance dependent on stockholder approval later in 2026.
About Plus Therapeutics (NASDAQ:PSTV)
Plus Therapeutics, Inc is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for difficult-to-treat cancers. The company’s technology is designed to deliver radioactive agents directly to tumors while limiting exposure to surrounding healthy tissue.
Its lead investigational product is rhenium-186 nanoliposome, also known as 186RNL or RNL. The treatment uses nanoliposomes to encapsulate the radioisotope rhenium-186 and is being evaluated for cancers affecting the central nervous system, including recurrent glioblastoma and leptomeningeal metastases.
