Thermo Fisher Submits PMA Application to FDA for Universal CDx Test
News Nov 15, 2016
In its ongoing effort to help enable the era of precision therapies in oncology, Thermo Fisher Scientific has announced that it has filed the final module of a premarket approval (PMA) application with the U.S. Food and Drug Administration (FDA) for its Oncomine Universal Dx Test, a multi-gene, next-generation sequencing (NGS)-based assay for non-small cell lung cancer (NSCLC). If approved, the universal gene panel could be the first of its kind in the United States, and would serve as a companion diagnostic (CDx) utilized to select patients for specific NSCLC therapies.
The test would also be accessible to global pharmaceutical companies for ongoing development of therapeutic drugs. The universal CDx is designed to simultaneously screen patient tumor samples for multiple gene variants with a single test - minimizing the need to perform numerous sequential tests that identify individual biomarkers one at a time. Sequential testing is difficult in NSCLC cases. Samples are often limited and can create the need for additional invasive and sometimes dangerous biopsies if the tissue is depleted before a complete genetic profile is obtained.
This traditional approach can also significantly delay identification of the right treatment, time that the patient often does not have given the rapid progression of the disease and that it is often detected at later stages. Alternatively, the Oncomine Universal Dx Test can return genetic data in less than five days using just 10ng of DNA. “As pharmaceutical companies shift toward developing new targeted therapies as opposed to 'one-size-fits-all' drugs, there is a clear need to more efficiently stratify cancer patients and tailor their treatments to enable better health outcomes,” said Joydeep Goswami, president of clinical next generation sequencing at Thermo Fisher Scientific.
“A companion diagnostic of this kind holds the promise to make precision medicine a reality. We are excited to reach this significant milestone, which brings us a step closer to realizing the potential that targeted NGS may bring to advance treatment for cancer patients.” The Oncomine Universal Dx Test has been optimized as part of Thermo Fisher’s previously announced long-term collaboration with Novartis and Pfizer aimed at driving a paradigm shift in the way cancer patients are selected for drug therapies and the speed at which new NSCLC drugs are developed and registered.
Thermo Fisher’s PMA submission includes clinical and analytical claims associated with NSCLC biomarkers, and comes after the successful completion of clinical trials using patient samples provided by Novartis and Pfizer. The end-to-end, highly sensitive solution has been developed using Thermo Fisher’s Oncomine and AmpliSeq technologies and validated on the Ion PGM Dx System. The genes and biomarkers included in the test were selected from the Oncomine Knowledgebase, one of the world’s largest collections of curated oncology data, and confirmed with industry-leading pharmaceutical partners.
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