Posts From the monthly archives: "November 2015"

We’ve been continuing to analyze the CMS reimbursement data that we received via our FOIA request, and for this post I analyzed the variability in the amounts at which tests were reimbursed by CMS during 2014. The net conclusion is that variability appears to be quite high. For the four common cancer biomarkers that…(Read More)

Since the inception of this blog over 4 years ago, one of the key topics has been companion diagnostic testing for cytochrome p450 (CYP) mutations. Indeed this was the topic of the very first post. Testing for these mutations is increasing rapidly, but CYPs remain in a funny place. They are acknowledged in FDA-approved…(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)

In a recent post we introduced the idea of the Personalized Medicine Scorecard, and to further develop these rankings we promised to analyze the pipelines of each company in the Scorecard. Download the Scorecard Whitepaper here. As a first step in this effort, this week we present an analysis of the oncology pipelines for three…(Read More)

We have just completed the latest data update to BiomarkerBase, which includes the following new information: 3,199 Biomarkers (unique Target/Disease combinations) 10,224 Clinical Trials 9 Diseases As we mentioned in our last product update post, this is the second of a few product updates in October. That brings the grand total in…(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)

Thanks to one of my LinkedIn contacts, I was introduced to a newly released “scorecard” that ranks pharmaceutical and biotechnology companies based on their precision medicine efforts. In essence, the organizations who made the cut are the ones moving precision medicine forward. They’re the ones focused on leveraging biomarkers to develop new therapies.  The…(Read More)

CMS has finally released its plan for market-based reimbursement of lab testing, and early reaction from industry seems to be that large test providers such as Quest and LabCorp will benefit most from the new system. The new system requires that “applicable laboratories” report to CMS rates from private payers for lab tests and…(Read More)


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