When we first launched BiomarkerBase, we put together a wishlist of meetings we’d like to attend to share our product and our company’s vision. It’s no surprise that the American Association of Clinical Chemistry (AACC) annual meeting was at the top of that list. We were finally able to make good on this intention and attend this year’s meeting in Atlanta.
They have a GIGANTIC annual meeting with attendance by the who’s who of diagnostic developers and lab equipment developers. These guys are our sweet spot for BiomarkerBase. We understand the competitive analysis and target identification use cases for diagnostic development companies well. So, the meeting was a major target of our marketing efforts for the year.
For this blog post, I want to cover some of the highlights of the AACC meeting, at least for me. If you’ve read some of the other posts on this blog you know that we are VERY interested in the regulation guidance from the FDA on Laboratory Developed Tests – LDTs. This was a hot topic at the AACC meeting this year.
But let’s start with the opportunities identified to improve BiomarkerBase for all of our users. One interesting example….Breast Cancer. I attended a session about new biomarkers for breast cancer. The investigators and company (Sphingotec, Germany) are developing pro-neurotensin and pro-enkephalin for predicting breast cancer risk. They’ve got some great data from retrospective studies and this looks like a promising method for choosing preventative hormone replacement therapy, which is effective, but has side effects. What was interesting is that there are no trials in CT.gov. The retrospective study was published in 2012 and there is a patent for neurotensin and breast cancer. We will watch these markers carefully for the launch of a trial. These seem to be well-established emerging biomarkers.
Similarly, conference abstracts have some interesting biomarkers that are phase 1 and unphased, providing us a huge opportunity to improve BiomarkerBase’s coverage of emerging biomarkers.
We are very excited to get biomarkers like the two examples above into BiomarkerBase and to improve our coverage of emerging Biomarkers, particularly for the competitive analysis and target identification use cases.
During Tuesday’s Medical Transparency Keynote Dr. Marty Makary of Johns Hopkins University discussed errors (“variations”) in medical treatment causing 210k deaths/year. That would be the third leading cause of death in the country, behind cancer and heart disease (600k each) and ahead of lower respiratory tract infections (130k/year).
We are passionate about BiomarkerBase’s role in improving personalized medicine and we believe we can play an important role in improving these numbers.
There was a lot of chatter about LDTs at this years meeting. An attendee of one of the sessions summed it up nicely when he said, “it’s going to be a rough ride….” The other telling part was the poor beleaguered FDA guy responding to the Vanderbilt lab guy: “the answers to a lot of your questions [he had 13 of them, with their own sub-points] are in the guidance document….”
GenomeWeb did a good job summing up the sentiment around LDT regulation. How LDTs are defined was of particular interest to diagnostic developers. The overlap of regulation between the FDA and the Centers for Medicare and Medicaid Services, under CLIA, was of particular concern. Again, “it’s going to be a rough ride….”
Particularly, the stipulation that gives the FDA risk-based discretion on when to regulate LDTs seems to be insufficiently defined and makes both the diagnostic developer communities and the medical communities uncomfortable, justifiably. As we’ve stated on our blog we are concerned about stifling innovation through LDT regulation.
We support of registry database, but, generally, not FDA oversight and regulation. This is the last major point around LDTs that was once again voiced. If a developer wants to add a new biomarker to a test how much regulation overhead is necessary to re-approve the test. In my opinion, this is the key question that needs to be answered before putting in place any regulation that could impede this type of innovation. At Amplion we believe this is going to reduce quality of care and much-needed innovation.
In general, the AACC meeting confirmed our focus on improving our coverage of emerging biomarkers for competitive analysis and target identification use cases, at least for diagnostic developers. It also reinvigorated our passion for delivering on the promise of personalized medicine and BiomarkerBase’s role. It’s achievable and only a matter of time.