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FDA Approves First NGS Based Companion Diagnostic

9 months, 1 week ago

2934  0
Posted on May 14, 2018, 2 p.m.

Next generation sequencing based companion diagnostics with the potential to detect multiple lung cancer mutations has been approved by the FDA. Unlike most test that are run exclusively by labs in which they were developed, these NGS based tools can be distributed all over the USA, FDA approval signal shifts in diagnostics.

Only a single tumor biopsy specimen is required by Oncomine DX Target Test diagnostics to identify 369 variants in 23 genes in a single assay for lung cancer. Oncomine was developed by Thermo Fisher Scientific in collaboration with Pfizer and Novartis.

Serving as a companion diagnostic for certain drugs, including combination drugs for BRAF mutations, which were also recently cleared by the FDA for non-small-cell lung cancer; oncologists will be able to make treatment decisions based on any variant on the panel.

Building on previous developed Thermo Fisher technology, Oncomine requires 10 ng of nucleic acid to test tumor samples for genetic markers. Oncomine is not very compatible with the whole exome or whole genome sequencing, but is effective at sequencing targeted to limited tumor specimens.

Sequencing metastatic lung cancer biopsy samples can prove to be difficult as tumor biopsies generally yield small amounts, making minimal DNA/RNA requirements of the Oncomine platform beneficial for panel testing for lung cancer. Primarily developed for in vitro diagnosis of lung cancer, as the disease has multiple molecular subtypes of targeting drugs currently being developed, Oncomine provides analytically validated sets of genes which will provide insights into physiopathology of lung cancer, enabling testing of efficacy of new drugs and treatments developed.

Researchers are satisfied that Thermo Fisher will quickly make improvements to the application of this tool as a companion diagnostic for in vitro colon cancer as well as other cancer types covered by the genes on the panel.

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

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