OncoHost Expands PROphetNSCLC® Precision Oncology Test Nationwide with New York State Laboratory Permit
核心洞察
OncoHost (搜索) received a laboratory permit from the New York State Department of Health Wadsworth Center (搜索), enabling the company to offer its PROphetNSCLC® (搜索) test to physicians and patients across New York State.
The AI-powered proteomic profiling platform analyzes thousands of plasma proteins from a single blood sample to generate personalized probability of clinical benefit from PD-1 (搜索)/PD-L1 (搜索) inhibitors for metastatic non-small cell lung cancer (搜索) patients.
With this regulatory achievement, PROphetNSCLC® (搜索) is now officially available for clinical use in all 50 U.S. states, marking a significant milestone in the company's U.S. expansion.
OncoHost (搜索) announced it has received a laboratory permit from the New York State Department of Health Wadsworth Center (搜索), enabling the precision medicine company to offer its PROphetNSCLC® (搜索) test to physicians and patients across New York State. This regulatory milestone marks a key achievement in OncoHost's U.S. expansion strategy and brings the AI-powered precision oncology test to nationwide availability.
Regulatory Validation and Quality Standards
The New York State Department of Health's permit reflects the rigorous standards required for clinical laboratory operations and validates OncoHost (搜索)'s commitment to quality, accuracy, and compliance. According to CEO Ofer Sharon, MD, "New York State maintains some of the most stringent laboratory certification requirements in the U.S., and meeting these standards underscores our scientific rigor, operational excellence, and dedication to clinical impact."
The New York permit joins OncoHost (搜索)'s existing certifications under the Clinical Laboratory Improvement Amendments (搜索) (CLIA) and its accreditation by the College of American Pathologists (搜索) (CAP), further strengthening the company's U.S. testing capabilities and expanding its clinical reach.
AI-Powered Precision Oncology Platform
PROphet®, OncoHost (搜索)'s AI-powered proteomic profiling platform, is designed to guide first-line treatment decisions in oncology. The proprietary test, PROphetNSCLC® (搜索), has been commercially available since 2023 and supports oncologists treating patients with metastatic non-small cell lung cancer (搜索) (mNSCLC (搜索)).
Using a single blood sample, the test analyzes thousands of plasma proteins to generate a personalized probability of clinical benefit from PD-1 (搜索)/PD-L1 (搜索) inhibitors, empowering physicians to optimize treatment selection and improve patient outcomes. The plasma-based, proteomic pattern analysis tool provides clear clinical utility by offering physicians crucial guidance on the optimal treatment plan for each individual patient, with a significant effect on overall survival.
Nationwide Clinical Access
With this latest regulatory achievement, PROphetNSCLC® (搜索) is now officially available for clinical use in all 50 U.S. states. Amir Gelman, PhD, Director of Laboratory Operations & Assay Development at OncoHost (搜索), emphasized the significance of this expansion: "Receiving this permit allows us to serve one of the nation's largest and most diverse patient populations. We're proud to deliver reliable, high-quality testing that supports oncologists in making data-driven decisions for their patients."
Clinical Development and Validation
OncoHost (搜索)'s precision diagnostics platform is supported by a large-scale prospective clinical trial with over 40 sites and 1,700 patients recruited worldwide. The company, led by an experienced team of entrepreneurs and industry experts, is positioned to advance precision diagnostics and biomarker development in oncology.
The technology company, headquartered in Binyamina, Israel, and Cary, North Carolina, is transforming the approach to precision medicine for improved patient outcomes through plasma proteomics and AI integration.