Big Developments in NGS Market: Assay Kits Appear

Big Developments in NGS Market: Assay Kits Appear

Most sequencing tests performed for clinical applications in the U.S. are laboratory developed tests (LDTs), according to Kalorama Information, meaning that the serviced is performed by test manufacturer and results sent to lab.  But the healthcare market researcher says this is changing and the change is noticeable with several developments in the past few months.  Kalorama Information covers sequencing markets in its report, Next-Generation Sequencing Markets.  

Sequencing Industry: Small But Growing

At this time there are only two FDA-cleared next-generation sequencing (NGS)-based in vitro diagnostic tests, the Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay and the Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay.  In addition, in the US, the FDA has approved the ViroSeq HIV-1 Genotyping System, which is performed on the 3700 Genetic Analyzer and is marketed by Abbott.  Outside of the US, Abbott also offers the CE-IVD marked Abbott HBV Sequencing Assay. 

This is changing, as the following developments indicate:

  •  In February 2017, Invivoscribe announced a long-term collaboration with Illumina to develop and commercialize in vitro diagnostic (IVD) assays for the next-generation sequencing MiSeqDx® platform. The announcement reported that under the terms of the agreement, Invivoscribewill work with Illumina to seek FDA clearance or approval of a number of biomarker and immuno-oncology assay kits for use on the MiSeqDx® instrument.  Invivoscribe already markets several CE-marked tests outside of the US under the brand name LymphoTrack® Dx Assays, and also Research Use Only (RUO) LymphoTrack® Assays, for use on the MISEQ® platform.  This is part of an ongoinginitiative of Invivoscribe to develop and provide standardized molecular diagnostic assays to support precision medicine in the oncology field.  Invivoscribe also offers CE-IVD LymphoTrack® Dx Assays, and also Research Use Only (RUO) LymphoTrack® Assays for Fisher Scientific's ION PGM next generation sequencing platform.  
  • In addition to these IVD products, on December 2016, the FDA approved Foundation Medicine's FoundationFocus™ CDxBRCA for use as a companion diagnostic to aid in identifying women with ovarian cancer for whom treatment with Rubraca™ (rucaparib) is being considered. Foundation Medicine's test is performed as a service in the company's CLIA-certified laboratory. 
  • In addition, also in February 2017, Asuragen announced that it had entered into a collaboration agreement with Thermo Fisher Scientific for the development and commercialization of capillary electrophoresis-based in vitro diagnostics.  The press release announced that Asuragen will leverage its AmplideX® PCR/CE product technologies to develop diagnostic kits for the 3500 Dx Series Genetic Analyzer CS2 instrument.  The3500 Dx Series Genetic Analyzer CS2 is based on Sanger sequencing.
Kalorama routinely keeps tabs of the next-generation sequencing market with particular attention to the impact of sequencing on clinical diagnostics.  Kalorama’s latest report, Next Generation Sequencing Markets, contains market estimates for whole and targeting sequencing and breaks out the market for geography and company market share.  The report can be found at: