NIH Reporter #1R44CA306750-01

Development and validation of Lung-FAST PCR-based lung cancer diagnostic kit

This opportunity involves the National Cancer Institute (NCI) awarding a project to develop and validate Lung-FAST, a PCR-based diagnostic kit for lung cancer mutations. - Government Buyer: - National Cancer Institute (NCI) - OEMs and Vendors: - Cereus Diagnostics Corp. (developer and manufacturer of Lung-FAST) - Products/Services Requested: - Lung-FAST PCR-based lung cancer diagnostic kit - Designed to detect mutations: EGFR, KRAS, ALK, MET, RET - Clinical-grade kit with six-month shelf life - Analytic validation services - Validation on 20 FFPE samples and 40 biopsies - Further validation on 400 diverse lung cancer samples - Unique/Notable Requirements: - Kit must be rapid, cost-effective, and suitable for small biopsy samples - Aim for FDA submission and potential laboratory-developed test deployment - Focus on clinically actionable mutations for targeted intervention - No specific part numbers or commercial OEMs beyond Cereus Diagnostics Corp.

Description

This project involves the development and validation of Lung-FAST, a rapid, cost-effective PCR-based test designed to detect clinically actionable genetic mutations in lung cancer. The scope includes analytic validation on biopsy samples, development of a clinical-grade kit with a six-month shelf life, and validation on 400 diverse lung cancer samples. The goal is to enable early, targeted therapeutic intervention and rescue biopsies that are too small for standard next generation sequencing. The project is funded by the National Cancer Institute and aims to benefit approximately 80,000 patients annually with faster diagnostic results.

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