Summary & Overview
CPT 0435U: ChemoID Ex Vivo Chemosensitivity Drug‑Response Assay
CPT code 0435U designates a Proprietary Laboratory Analyses (PLA) test — specifically the ChemoID® assay produced by ChemoID® Lab and Cordgenics LLC — that evaluates ex vivo chemosensitivity by exposing bulk tumor cells and cultured cancer stem cells from a fresh tumor biopsy to a minimum of 14 chemotherapy agents or combinations. The code matters nationally as molecular and functional tumor profiling increasingly informs personalized oncology care and influences laboratory billing, coverage, and utilization patterns. Key payers reviewed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise explanation of the clinical intent and laboratory setting for the test, an overview of common payer coverage landscapes and policy considerations, and what benchmarks and documentation elements typically matter for billing and claims adjudication. The report also outlines clinical context for use—targeting treatment selection in oncology through functional drug-response data—and summarizes where data is available and where input is limited. Data not available in the input includes specific payer coverage policies, reimbursement rates, ICD-10 linkage, and provider taxonomies.
Billing Code Overview
CPT code 0435U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the ChemoID® test marketed by ChemoID® Lab and Cordgenics LLC. The assay uses bulk tumor cells and cultured cancer stem cells derived from a fresh tumor biopsy to measure drug-response and cytotoxicity for a minimum panel of 14 chemotherapy drugs or drug combinations. This test is intended to inform selection of chemotherapeutic agents based on ex vivo sensitivity.
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Service type: Drug-response in vitro chemosensitivity assay using fresh tumor biopsy and cultured cancer stem cells
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Typical site of service: Clinical laboratory or specialized molecular/pathology laboratory performing Proprietary Laboratory Analyses
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult with a recently diagnosed solid tumor (for example, high-grade glioma, ovarian carcinoma, or metastatic colorectal cancer) who is a candidate for systemic chemotherapy and for whom oncologists seek a personalized ex vivo drug-sensitivity profile. The patient undergoes a diagnostic or therapeutic tumor biopsy or surgical resection during which a fresh tumor specimen is collected and promptly transported to the performing laboratory (ChemoID® Lab / Cordgenics LLC) under controlled conditions. The laboratory isolates bulk tumor cells and enriches or cultures cancer stem cells, then performs a standardized drug–response cytotoxicity assay testing a minimum panel of 14 chemotherapy agents or combinations. Results report agents with highest and lowest cytotoxic activity against the patient’s tumor cells to inform multidisciplinary tumor board discussions and individualized treatment planning. Typical sites of service include hospital outpatient surgical suites, ambulatory surgical centers, and hospital inpatient operating rooms when biopsy or resection occurs. The service type is a proprietary laboratory analysis (PLA) performed by a commercial diagnostic laboratory, billed by the performing laboratory using PLA code 0435U after receipt of the fresh tumor specimen.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Use when no separate modifier applies; report code as submitted |