Thermo Fisher Scientific has entered an agreement with Novartis and Pfizer to develop a next-generation sequencing-based (NGS) companion diagnostic (CDx) test.

The multi-marker, universal NGS oncology test will serve as a CDx for non-small cell lung cancer (NSCLC) across multiple drug development programmes.

NGS allows testing of multiple genes simultaneously from a single sample, which will help in identifying their unique genetic profile. Generated data will be used to guide the appropriate therapy choice among multiple drug candidates.

This streamlined and personalised methodology will have the potential to improve safety, effectiveness and health outcome of patients via targeted risk stratification and tailored treatment approaches.

Under the deal, the NGS-based CDx test for NSCLC will be developed using Thermo Fisher’s Ion PGM Dx system and Oncomine assays.

"The potential to generate a paradigm shift through this agreement represents a significant step forward in realising the promise of precision medicine."

Both NGS platform and Oncomine reagents use the Ion AmpliSeq technology, which allows simultaneous sequencing of hundreds of genes.

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By GlobalData

The deal will also accelerate the development and registration of several new NSCLC drugs and drug indications, in a bid to provide patients with more targeted treatments, as well as access to appropriate clinical trials.

The Ion Torrent-based sequencing platform and reagents are combined with its low DNA and RNA sample input requirements from Formalin-Fixed Paraffin-Embedded (FFPE) tissues.

They offer comprehensive sequence analysis of a wider variety of tumour samples, including limited or compromised specimens derived from FFPE tissue or fine needle aspirates.

Thermo Fisher Scientific life sciences solutions president Mark Stevenson said: "The potential to generate a paradigm shift through this agreement, from one test for one drug, to one test for multiple NSCLC therapies, represents a significant step forward in realising the promise of precision medicine.

"We look forward to building upon our ongoing collaboration with Novartis and Pfizer to lead the efforts in building potential novel NGS testing approaches to advance the future of cancer care."

In October, Thermo Fisher secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new immunoassay to specifically detect hydrocodone.

The semi-synthetic opioid hydrocodone is an antitussive (cough suppressant) and narcotic analgesic agent that can be used to treat moderate to severe pain.