Lung cancer fast (fragment analysis, SNP, and translocations) testing

Cereus Diagnostics Corp. received a $764,448 Project Grant from the National Cancer Institute under the Cancer Detection and Diagnosis Research Program (CFDA 93.394) awarded on August 1, 2025, with completion targeted for July 31, 2028. The company is developing LUNG-FAST (Fragment Analysis, SNP, and Translocations), a rapid polymerase chain reaction (PCR)-based diagnostic test designed to detect clinically actionable lung cancer mutations including EGFR, KRAS, ALK, MET, and RET variants. The test addresses critical limitations of current Next Generation Sequencing (NGS) methods by requiring minimal DNA/RNA input (as little as 5 mg), achieving sensitivity as low as 0.1% for DNA and 0.01% for RNA, and delivering 96% accuracy in genetic fusion detection.

The funded project encompasses three integrated deliverables: (1) analytical validation studies on formalin-fixed paraffin-embedded (FFPE) tissue samples and previously rejected biopsies to demonstrate detection limits of 0.001-0.1% variant allele frequency; (2) development and production of a clinical-grade LUNG-FAST kit with validated six-month shelf life and scalability for consistent manufacturing; and (3) clinical validation testing on 400 lung cancer samples from diverse populations across two major medical centers, targeting 95% accuracy and a four-hour turnaround time. Upon completion, these studies will support FDA submission and development of a Research Use Only (RUO) product to assist laboratory-developed tests, with potential to recover approximately 30% of biopsies currently rejected by NGS and benefit approximately 80,000 patients annually.

Abstract

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.