The permit enables the company to offer its PROphetNSCLC test to physicians and patients across New York State, completing nationwide availability.
OncoHost has received a laboratory permit from the New York State Department of Health Wadsworth Center, enabling the company to offer its PROphetNSCLC test to physicians and patients across New York State.
The permit marks a milestone in OncoHost’s US expansion and reflects the stringent standards required for clinical laboratory operations in New York State. With this regulatory achievement, PROphetNSCLC is now officially available for clinical use in all 50 US states.
PROphetNSCLC, commercially available since 2023, supports oncologists treating patients with metastatic non-small cell lung cancer. Using a single blood sample, the test analyzes thousands of plasma proteins to generate a personalized probability of clinical benefit from PD-1/PD-L1 inhibitors.
The test is part of OncoHost’s PROphet AI-powered proteomic profiling platform, designed to guide treatment decisions in oncology.
“This permit is a significant step forward in making precision oncology accessible to more patients,” says Ofer Sharon, MD, CEO of OncoHost, in a release. “New York State maintains some of the most stringent laboratory certification requirements in the US, and meeting these standards underscores our scientific rigor, operational excellence, and dedication to clinical impact.”
Expanding Testing Capabilities
The New York permit joins OncoHost’s existing certifications under the Clinical Laboratory Improvement Amendments and its accreditation by the College of American Pathologists.
“Receiving this permit allows us to serve one of the nation’s largest and most diverse patient populations,” says Amir Gelman, PhD, director of laboratory operations and assay development at OncoHost, in a release. “We’re proud to deliver reliable, high-quality testing that supports oncologists in making data-driven decisions for their patients.”
The Binyamina, Israel-based company, which also operates in Cary, NC, focuses on plasma proteomics and AI to advance precision medicine approaches in oncology.
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