Le Lézard
Classified in: Health, Science and technology
Subjects: SVY, FDA

Forward Progress for Assay Kit Sequencing Approaches in Past Three Months


ROCKVILLE, Md., March 13, 2017 /PRNewswire/ -- At this time, 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.

At this time, Kalorama notes, 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:

Kalorama routinely keeps tabs of the next-generation sequencing market.  As a IVD-focused market research firm, they have assembled annual studies of 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: https://www.kaloramainformation.com/Generation-Sequencing-Systems-10290041/.

More of Kalorama's biotechnology market reports can be found at: https://www.kaloramainformation.com/biotechnology-market-c57/.

About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog on our company website.  

Please link any media or news references to our reports or data to http://www.kaloramainformation.com/.

Press Contact:                                                         
Bruce Carlson
212 807 2262                                                         
[email protected]

 

SOURCE Kalorama Information


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