ROCKVILLE, Md., Feb. 8, 2017 /PRNewswire/ -- Research firm Kalorama Information said the last FDA statement on lab developed tests (LDTs) provided no clarity on regulatory intentions, setting up the FDA under the new administration to act in the way it wishes. Uncertainty about the regulation of laboratory developed tests (LDTs) is an ongoing major issue for clinical laboratories, and this uncertainty continues as the FDA issued a discussion paper on LDTs this month. It has been over two years since the FDA issued a draft guidance on regulation of LDTs, plus a second guidance document on FDA notification and medical device reporting for LDTs. The proposals in the guidance on regulation of LDTs were controversial, and were opposed by the laboratory community. In November 2016, in the wake of uncertainty following the presidential election, the FDA announced that it would delay finalizing the draft guidance on LDTs.
On January 13, 2017, the FDA issued a "Discussion Paper on Laboratory Developed Tests (LDTs)." This discussion paper synthesizes feedback that the FDA received on the 2014 draft guidances, and proposes a prospective oversight framework. Some of the proposals in the discussion paper include "grandfathering" LDTs (except when required to protect public health), exempting certain categories of new or significantly modified LDTs, reduced time-frame for phasing in regulation of LDTs with risk-based and phased-in oversight, evidence standards, third-party review, clinical collaboratives, transparency, quality system requirements, and post-market surveillance.
Kalorama Information is a New York City-based IVD market research firm. It covered molecular diagnostics in its report, The World Market for Molecular Diagnostics, 7th Edition. In that report, Kalorama said the LDT market is an important driver of molecular sales of probes and other reagents purchased from IVD manufacturers for use in tests that labs create for themselves and some large companies market to smaller labs as a service product. It also has some effect on instrument sales for molecular diagnostics equipment.
"Since the final FDA paper of the Obama administration gave no definitive answer on regulation, maybe LDTs are here to stay as increased oversight is not likely in the new admin," said Bruce Carlson, Publisher of Kalorama Information. "That's good and bad for molecular diagnostic companies, according to our report. On one hand LDTs provide income to diagnostic companies, though on the other hand they may have preferred to market packaged kits into labs."
In the discussion paper, the FDA states: "In the absence of issuing final guidance and at the request of stakeholders, we feel it is our responsibility to share our synthesis of all the feedback we have received, with the hope that it advances public discussion on future LDT oversight." This discussion paper is not a substitute for a final FDA guidance, and it is not possible at this time to predict what the final LDT regulations will be. Also, it is impossible to predict when this uncertainty will end. A Regulatory Affairs Professionals Society (RAPS) paper provides more discussion on the FDA's latest statements.
Kalorama Information's The World Market for Molecular Diagnostics, 7th Edition provides information on several segments of molecular testing, as well as geographic breakouts of the market and market share by category of test. Competitive analysis and profiles of companies is also provided.
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.
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SOURCE Kalorama Information