FDA Watch: Another First as Agency Approves NGS Oncology Companion Dx for Multiple Therapies

The FDA made a stir in May by approving a cancer drug (Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor from Merck) administered on the basis of a tumor’s genomic features rather than its location in the patient’s body. Barely a month later, came a new surprise from the agency: premarket approval to Oncomine Dx Target Test, Thermo Fisher Scientific’s next generation sequencing-based companion diagnostic for non-small cell lung cancer (NSCLC) diagnostic that simultaneously screens for biomarkers associated with three FDA-approved therapies. The test was approved to detect multiple gene mutations (BRAF, ROS1, and EGFR) from a single tissue specimen. The results of the test aid in selecting targeted therapies, including IRESSA (gefitinib) for EGFR L858R and Exon 19 deletions, Tafinlar + Mekinist (dabrafenib in combination with trametinib) for BRAF V600E, or XALKORI (crizotinib) for ROS1 fusion.

Thermo Fisher says that the test kit enables quicker matching for targeted therapies, through a single test rather than sequential testing. The company also says the test will be available in the U.S. beginning in July 2017. LabCorp’s Diagnostics and Covance Businesses, NeoGenomics Laboratories, and Cancer Genetics, are the first laboratories offering the test. The test is run on Thermo Fisher’s Ion PGM Dx System, which received FDA 510(k) clearance in parallel for use on formalin-fixed, paraffin-embedded (FFPE) tissue samples.

"This first iteration of the test is just the beginning since the diagnostic claims of the Oncomine Dx Target Test may be expanded in the future based on the existing panel," said Joydeep Goswami, Thermo Fisher’s president of clinical next-generation sequencing and oncology, in a statement. "Thermo Fisher has entered into discussions with several pharmaceutical companies looking to use the panel for FDA-approved targeted therapy applications beyond lung cancer."

The Oncomine Dx Target Test also currently targets an additional 20 NSCLCassociated gene variants currently being investigated in clinical trials that may be actionable in the future. The company expects that as other drugs are approved, the FDA will expand approvals on the panel.

Here’s a look at key FDA diagnostics approvals in late June through July:


Manufacturer(s) Product(s)
Great Basin Approval of stool bacterial pathogens panel for simultaneous detection of bacterial pathogens Salmonella, Shigella, Shiga Toxin-producing E. coli and Campylobacter
Illumina (with Amgen) Approval of extended RAS Panel, a companion DX run on its MiSeqDx system to analyze variants in KRAS and NRAS genes to determine if patients will benefit from Amgen’s Vectibix (panitumumab)
Abbott Approval of RealTime CMV molecular test for amplifying 2 select regions of CMV genome
Hologic Approval to market Aptima Herpes Simplex Virus 1 & 2 molecular assay on its fully automated Panther system
Techlab Approval of E. Histolytica Quik Chek, rapid assay for qualitatively detecting E. histolytica in fecal samples
Thermo Fisher Scientific Approval of Oncomine Dx Target Test, NGS-based based companion diagnostic for analyzing alterations in panel of genes predictive of response across 3 non-small cell lung cancer treatments
Thermo Scientific Approval to market CEDIA Buprenorphine II assay
Bio-Rad Laboratories Approval to market BioPlex 2200 Syphilis Total & RPR (rapid plasma reagin) assay for diagnosing syphilis infection

In addition, DxNA announced that it has applied for 510(k) clearance of GeneSTAT, its real-time PCR system and test for Valley Fever.

New CE Marks & Global Certifications
Here’s a summary of notable European CE certifications:


Manufacturer(s) Product(s)
NGeneBio Approval of its BRCAaccuTest and clinical analysis software
Roche Approval of Cobas methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) nucleic acid test for use on firm’s Liat PCR point-of-care platform
GenMark Diagnostics Approval of its ePlex BCID gram-positive and gram-negative panels
Hologic Approval of upgrade to its existing Panther Fusion diagnostic system and for Panther Fusion flu and respiratory testing assays
Luminex Approval of Aries Norovirus Assay for rapid detection and differentiation of norovirus genogroup I and II from stool specimens of people with acute gastroenteritis symptoms
Mobidiag Approval of Amplidiag Viral GE gastrointestinal virus PCR-based test for simultaneous detection of diarrhea-causing enteric viruses

Other international certifications during the period included:

  • Health Canada’s approval of 3M’s second-generation molecular assay for detecting Listeria in food and environmental testing;
  • Approval of Vela Diagnostics’Sentosa SQ HIV genotyping assay in Australia and its Sentosa SQ melanoma panel in Singapore; and
  • South Korea’s approval of Altona Diagnostics’ RealStar Zika Virus RTPCR Kit.

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