FDA Approves First Ever NGS-Based Companion Diagnostic

Introduction

A next generation sequencing (NGS)-based companion diagnostic, with the potential to detect multiple lung cancer mutations, has been approved by the US Food and Drug Administration (FDA).

The approval signals a significant shift in diagnostics because, unlike “home brew” tests that can be run exclusively by the laboratories in which they were originally developed, the NGS-based tool can be distributed to laboratories all over the United States.

Oncomine Dx target test

Thermo Fisher Scientific (Waltham, Massachusetts) collaborated with Pfizer (New York) and Novartis (Basel, Switzerland) to create the new lung cancer diagnostic, called Oncomine Dx Target Test, which uses just one tumor specimen to identify 369 variants in 23 genes in a single assay.

An oncologist can make a treatment decision based on any variants on the panel. Moreover, the test serves as a companion diagnostic for certain drugs, such as the combination drugs for the BRAF mutations, which were cleared by the FDA in June 2017, for the treatment of non-small-cell lung cancer.

Application to lung cancer panel testing

The Oncomine platform is modeled on the Ion ApliSeq technology developed by Thermo Fisher. The technology necessitates the use of 10 ng of nucleic acid to test a tumor sample for numerous genetic markers. The technology is not so compatible with whole exome or whole genome sequencing, but it is extremely effective at targeted sequencing using limited tumor specimens.

Since tumor biopsies usually yield very small amounts, sequencing metastatic lung cancer biopsy samples it particularly difficult. Therefore, the minimal RNA/DNA requirement of Oncomine enables the panel testing for lung cancer.

This tool was primarily developed for in vitro diagnosis of lung cancer, which researchers are especially pleased about, as the disease has multiple molecular subtypes, targeted by several drugs or drugs currently being developed.

Therefore, the new test provides an analytically validated set of genes that will provide insights into the physiopathology of lung cancer and enable testing of the efficacy of new drugs and treatments.

Conclusion

Researchers are confident that Thermo Fisher will rapidly increase the application of the new tool as a companion diagnostic for in vitro colon cancer and other cancer types covered by the genes on the panel.

Reference

  • Nature Biotechnology, 35: 699, 2017.
  • Nature Biotechnology, 34: 895, 2016.

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Last updated: Apr 19, 2018 at 8:19 AM

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