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Posts Currently viewing the tag: "LDT Regulation"

In February of last year the FDA hosted a two-day workshop focused on technical and regulatory considerations related to the use of next generation sequencing (NGS) diagnostics in clinical practice.  This was a very forward-thinking move on the part of FDA, as clinical NGS is advancing rapidly and will soon become routine in…(Read More)

We have written extensively about health system regulation in this blog, with a keen interest in how LDT regulation will shake out.  In our other blog we’ve even argued strongly for caution in LDT regulation, primarily to avoid stifling innovation.  However, our tune is changing as more and more evidence has been provided that…(Read More)

In this blog we have regularly assumed (without hard data until now) that most biomarker innovation was taking place in laboratory-developed tests (LDTs) as opposed to tests cleared and approved by FDA, and we can now confirm that this assumption is correct. Now that we include LDTs in BiomarkerBase we were able to analyze…(Read More)

In mid-2015 we worked hard to add a new source of evidence for biomarkers: Laboratory Developed Tests, or LDTs.  This was a huge milestone for Amplion.  We successfully used our technology to identify biomarkers in a new information source very quickly without sacrificing quality.  We identified over 1000 biomarkers that we had not seen…(Read More)

At Amplion we have a commercial interest in access to high quality clinical information that can inform and contribute to our flagship product, BiomarkerBase.  However, we are truly passionate about contributing to higher quality, more personalized, medical advancements that improve the overall health of our communities.  We want to contribute to delivering on the promise…(Read More)

We’ve covered the LDT regulation evolution for some time now.  To give some perspective we’ve created the following infographic showing the history of LDT regulation.  To use it in your own content check out the code snippet below the infographic.  We only ask that you include attribution to www.amplion.com/biomarker-trends…(Read More)

For a long time now I have been pushing FDA to provide evidence to back up its claim that LDTs have introduced risk to patient populations. That evidence has now been provided, and it is compelling. FDA has just published a case for LDT regulation based on 20 case studies of patient risks due to…(Read More)

The U.S. House of Representatives Committee on Energy and Commerce is holding a hearing entitled “Examining the Regulation of Diagnostic Tests and Laboratory Operations” on November 17 at 2pm ET (note that the date was re-scheduled from an earlier date). The hearing will consider proposed legislation which could augment/supplant FDA’s proposal…(Read More)

An FDA official recently stated that the final version of the draft guidance regarding regulation of laboratory-developed tests (LDTs) is not likely to be released before the end of this year. Elizabeth Mansfield, director of personalized medicine at the FDA’s Center for Devices and Radiological Health, was a panelist at the Clinical Laboratory…(Read More)

FDA and CMS have just announced that the agencies are forming a joint task force to explore “areas where collaboration may realize greater oversight efficiency and produce the greatest benefit to patients, providers, and laboratories.” This is a laudable effort that should ensure a minimum of overlapping regulation. FDA has played a central role throughout…(Read More)