Kalorama: Keep An Eye On These Three IVD Trends in 2015

NEW YORK, Jan. 28, 2015 — (PRNewswire) — Kalorama Information says LDT regulation, new markets, and better sequencing tools are among the trends to watch in 2015.  The healthcare market research firm specializes in in vitro diagnostic market forecasts and trends and said that 2015 may be the year where topics much talked-about may be resolved. The firm's 9th comprehensive study of the IVD market was published mid 2014 and the firm plans large studies in next generation sequencing and molecular diagnostics this year. 

Kalorama Information

Kalorama Information's report, The Worldwide Market for In Vitro Diagnostic Tests, 9th Edition, is available from Kalorama Information at http://www.kaloramainformation.com/Worldwide-Vitro-Diagnostic-8326563/.

Trend One: Sample-to-Answer Sequencing:  Next generation sequencing technologies are creating low-cost diagnostic tools that can enable widespread clinical adoption.  But according to Kalorama Information, there is a hold up:  Many research laboratories performing next generation sequencing have had to determine what sample preparation protocols or procedures they would use, which sequencing platform they would use, and then which software solutions they would use to analyze and interpret the data.  Setting up and validating this complete workflow requires considerable expertise and time.

"While the workflow set up and validation can be done by research laboratories, customers often prefer a single group of instruments and software, or a single platform, to perform the entire next generation sequencing experiment or test," said Bruce Carlson, Publisher of Kalorama Information.

Several companies are now developing sample to-answer (or sample-to-insight) workflows and platforms to address these two hurdles, and to reduce the time required to generate a test result to hours instead of days or weeks.   For instance, GenapSys's GENIUS™ 110 system (Gene Electronic Nano--Integrated Ultra--Sensitive), a fully integrated DNA sequencing system that utilizes a pure electronic semiconductor based sequencing chip and multi-use reagent cartridge, and has a footprint the size of an iPad.  Oxford Nanopore's MinION™, PromethION™ and GridION™ - Each based on nanopore sensing technology.  Also, Qiagen is developing the integrated, automated sample-to-insight GeneReader NGS benchtop workflow.

Trend Two:  LDT Regulation – Lab developed tests (LDTs) are the norm for top laboratories performing clinical diagnostics, but Kalorama Information thinks the regulatory situation in 2015 is on the brink of change. 

"These tests do not need to be approved or cleared by the FDA because it was always understood that they were used in a single laboratory and were a lower enforcement priority," Carlson said.  "That view is changing, and 2015 may be where the view point of the agency and the industry will be debated."

Last year, the FDA  notified Congress of a draft guidance through which the agency would propose to establish an LDT oversight framework, including pre-market review for higher-risk LDTs, such as those that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market.  

From the FDA 's point of view, the LDTs may have to be regulated due to their effect on the regulated products they compete with.  Per an FDA statement: "Many LDTs are indistinguishable from regulated IVDs in that they are complex, software-driven and are performed in laboratories outside a patient's health care setting. In addition, many of these LDTs compete with FDA-cleared or –approved IVDs, posing a regulatory conundrum." 

The industry is not pleased with the looming regulation.  The Association for Molecular Pathology (AMP), an association representing molecular testing companies, expressed "concern" with the guidance, AMP says the current measures are sufficient to regulate LDTs, and that additional measures would be "burdensome."

Trend Three:  Next set of Emerging Countries.   With GDP growth in Brazil (5%) and China (7.5) slightly down from the double-digit GDP growth of five years ago, expect firms to look at other countries to provide the kind of emerging markets revenue they need for overall sales growth. "We still think Latin America is a growth area for IVD companies," Carlson said.  "But now we are hearing lot more interest in countries like Peru, Uruguay or Columbia.  In other areas of the globe, we see increased interest in market estimates for Turkey, Indonesia and Poland."

Kalorama Information has been observing trends in the in vitro diagnostic industry for two decades.  The firm publishes a biennial comprehensive study of the IVD market, which is now in its ninth edition.  Kalorama's The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 9th Edition is available at http://www.kaloramainformation.com/Worldwide-Vitro-Diagnostic-8326563/.

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. We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at  http://www.kaloramainformation.com/.  

Bruce Carlson
(212) 807-2622
Email Contact

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