Hello and welcome to the second half of the first Amplion company blog where I mapped out why our team is dedicated to seeing the promise of personalized medicine fully realized.

So now I’m going to cover why we believe that 510(k)-style regulation of LDTs should not be pursued. 510(k) is the simplest path for a diagnostic test developer to gain approval from the FDA. In essence, a diagnostic is approved through 510(k) if a diagnostic developer can show that the new test is equivalent to another approved diagnostic already on the market.

First, any 510(k)-style regulation of LDTs will stifle the only real source of innovation in our diagnostic test landscape. Amplion’s CEO, John Audette has written extensively about LDT regulation — and in the interest of objectiveness — not taking a stand either way.

If you haven’t already read these posts, I highly recommend you do. You can find his posts here. In one post, John highlights the stance taken by the Association of Molecular Pathology (AMP), argues that LDTs are already sufficiently overseen by Clinical Laboratory Improvement Amendments (CLIA.) Even though we broadly agree, we also support the implementation of a centralized LDT registry. A central database gives the industry the opportunity to identify adverse effects of LDT’s and what’s more, will improve patient safety and transparency.

In the same post John considers the dubious safety claims that are often trotted out in support of LDT regulation. The Ovasure Case was once again referenced — which is not only stale — but could be, to quote John,

“looked at as an example of existing peer review regulatory systems working as they should.”

510(k)-style regulation of LDT’s will stifle the innovation that’s happening almost exclusively in the LDT market. Without the overhead and expense of FDA approval (which is unnecessary because these tests are delivered as a service) LDT’s are a relative utopia of innovation and application of current science.

This is best exemplified by a quote in one of John’s posts from an executive at a leading diagnostic company,

“It’s not quite ‘circle-the-wagons’ time around here, but there definitely isn’t much appetite for trying new things.”

With 510(k) as the main process for getting biomarker-based tests through the FDA, only three have been approved per year on average for the last 12 years and in 2014, they took on average, of 7.5 months to get approval. That’s an increase of five months from the 2.5 month on average in 2003. For more alarming details on the state of diagnostic test approval, download our most recent report.

That’s not even taking into account how quickly FDA-cleared tests can become out-dated. While covering a recent FDA workshop on LDT regulation, John unearthed some interesting examples of how regulation can hurt patients. Specifically, examples of out-of-date FDA-cleared test that don’t cover standard-of-care and result in a mis-application of treatment.

LDTs, by contrast, are a shining light in innovation and currency. ARUP for instance updates all of their 1,500 LDTs at least once per year. Taking away the agility of labs like ARUP will result in monopolizing mega-labs who are the only test providers that can afford the FDA regulatory process. John does a nice job of summarizing the pro and con arguments for LDT regulation.

We generally believe that regulation will keep the scrappy startup from creating an innovative diagnostic product that pushes the envelope and pushes us closer to targeted therapies and ultimately, personalized medicine.

To put a finer point on the effect that innovation in LDTs has on the market, I’ll ask you to consider our pride and joy, BiomarkerBase™. We pulled down and evaluated the test menus for the four largest labs: Mayo, ARUP, Quest, and LabCorp.

We then indexed and evaluated the biomarkers for only the Mayo set. From only that set we identified over 1,000 biomarkers that were not referenced in any other public source. That’s greater than 30% more of the newest and most innovative biomarkers on the market today…from one lab! For that reason, we are excited to work on the other LDT providers over the next few months.

Our experience with LDT data in BiomarkerBase™ as well as the opinions of subject matter experts is why we believe 501(k)-style regulation of LDTs — with the dismal record of FDA-cleared tests — will stifle the work happening in labs. This will only prolong the inevitable emergence of personalized medicine without a significant safety benefit. We do support the creation of a centralized registry of LDTs that will give us the opportunity to log adverse incidents and make data-driven decisions to improve patient safety.

LDTs are a shining innovation beacon in the test landscape that will continue to be a major contributor to delivering on the promise of personalized medicine. This is what drives us at Amplion and the reason why BiomarkerBase™ exists.

We want to ensure that all steps in the healthcare, life science and biopharma value chain have access to information that will help make decisions specific to the patient. Understanding the biomarkers and the tests to identify those biomarkers is a key to delivering targeted therapies. We are excited about our role in making that possible.