Lung Cancer FAST (Fragment Analysis, SNP, and Translocations) Testing

Cereus Diagnostics Corp., Dallas TX

Investigators

Abstract

Project Summary Lung cancer is the leading cause of cancer deaths in the U.S., with over 235,000 diagnoses annually. Timely, accurate testing is crucial for effective treatment, but current methods like Next Generation Sequencing (NGS) are slow, costly, and ineffective for small biopsy samples. Cereus Diagnostics has developed Lung-FAST, a rapid, cost-effective PCR-based test that detects clinically actionable mutations (e.g., EGFR, KRAS, ALK, MET, RET). No additional genetic testing would be needed after performing Lung-FAST. Using as little as 5µg of DNA and RNA, Lung-FAST overcomes the limitations of small biopsies and offers sensitivity as low as 0.1% for DNA and 0.01% for RNA, achieving 96% accuracy in detecting genetic fusions. The project has three main aims: 1) Analytic Validation: Lung-FAST will undergo validation studies on 20 FFPE samples and 40 previously rejected biopsies to demonstrate improved detection. The goal is a detection limit of 0.001-0.1% variant allele frequency with minimal DNA/RNA input. 2) Clinical-Grade Kit Creation: The test will be developed into a clinical-grade kit, with stability and accuracy tests to ensure scalability and consistency. The milestone is the production of test kits with a six-month shelf life. 3) Clinical Validation: Lung-FAST will be tested on 400 lung cancer samples from diverse populations at two major medical centers. The goal is 95% accuracy and a four-hour turnaround time for results. Lung-FAST could revolutionize lung cancer testing by rescuing 30% of biopsies rejected by NGS, benefiting 80,000 patients annually. Faster results are critical for this disease where half of metastatic patients do not survive a year. Future development could expand to fresh lung cancer cytology samples for even quicker results. These studies will enable FDA submission, and at least creation of an RUO product to assist laboratory developed tests.