Report: Next-Generation Sequencing Finding a Place in Molecular Diagnostics

NEW YORK, Nov. 12, 2015 /PRNewswire/ -- Table top sequencers are gaining popularity especially for clinical testing, according to Kalorama Information.  The healthcare market research firm named several companies that have test services based on sequencing.  The firm's report The World Market for Molecular Diagnostics, 6th Edition provides detailed on these offerings. 

The report can be found at http://www.kaloramainformation.com/redirect.asp?progid=88032&productid=9314088.

"The power of NGS touches just about every facet of medicine and patient care," Shara Rosen, R.T., MBA, said. "As NGS costs drop, the analysis of individual human and pathogen genomes is expected to become the standard of care for many disease diagnostics."

According to the report, many important questions in medicine can be addressed by using individual genome sequence data to find, and understand, key genetic differences that explain why one person (or one tissue) gets sick, and another remains healthy. 

• In oncology, tracking genetic differences that distinguish tumors from other tissues can help drive treatment strategies, and monitor their effectiveness.
• In infectious disease, high-throughput genome sequence analysis can help rapidly identify microbes responsible for infections, and reveal underlying mechanisms of antimicrobial resistance.
• Genomic sequencing can also be used in the development of companion tests for personalized medicine.

Illumina's MiSeq and Fisher Scientific/Life Technologies' Ion Torrent Personal Genome Machine are the top competitors in the market for benchtop NGS instruments and tests.  Also entering the market are handful of other players, including Oxford Nanopore Technologies, GnuBio, NobleGen Biosciences, Stratos Genomics, Genia, Intelligent Bio-Systems, and LaserGen.  They are working on sequencing platforms, that are based on alternative technologies.   

There are some challenges however, and one of them is that authorities are less than prepared for the introduction of the technology for routine clinical use. Most NGS technology is restricted to research use only (RUO) or investigational use only (IUO), but CLIA-certified clinical labs often use RUO or IUO technology to develop laboratory-developed tests.  June 2010, the FDA published draft guidance indicating that reagents and platforms labeled RUO or IUO should not be supplied to clinical labs that perform diagnostic tests that use these reagents or platforms. If that guidance is implemented as currently stated, it will certainly complicate the use of NGS for diagnostic testing.

European regulations are more liberal when it comes to the use of new technologies.  Here the adoption of next-gen sequencing is related more specifically to laboratories ability to afford sequencing systems and very constricted reimbursement opportunities. 

"The transition of sequencing into routine medicine is anything but a slam-dunk," said Shara Rosen, Kalorama analyst and the author of the report.  "For sequencing to transition into a clinical diagnostic assay for conditions such as cancer, cardiovascular disease, autism, psychiatric applications and others, it needs to be precise, reproducible and cost effective.  More importantly diagnostics sequencing applications will have to be fully validated for their clinical utility."

More importantly, a growing list of the largest and most prestigious U.S. hospitals and reference labs are beginning to use NGS in their genome testing programs.  Several test services are now using sequencing.  More importantly, IVD companies from every segment of the industry have begun developing a sequencing business.  Adaptive Biotechnologies, Appistry, ARUP, Assurex Health, LabCorp, Illumina, and Mayo Medical Lab are among the companies with sequencing-based test service products. 

The report, The World Market for Molecular Diagnostics, 6^th Edition, includes market sizing and forecasts for eight categories of molecular tests as well as several segments.  In addition the report contains trend analysis, strategic recommendations, analyst conclusions and company profiles of over 190 companies.  The report can be found at: http://www.kaloramainformation.com/redirect.asp?progid=88032&productid=9314088.

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 at www.kaloramainformation.com.

Contact:
Bruce Carlson
(212) 807-2622
[email protected]
www.KaloramaInformation.com

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