Variability in Reimbursed Amounts for Biomarker-Based IVD Tests

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...

Is This a Big Opportunity for Diagnostic Test Developers?

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...

FDA Finally Provides Better Evidence of LDT Risks

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...

Biomarker Data Update: 3,199 Biomarkers, 10,224 Trials, 9 Diseases

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...

Real-Time COVID R&D Tracking

As COVID-19 infections continue to spread, organizations with technologies or devices that can support new drug, vaccine, or test development have a life-saving contribution to make. The Amplion Intelligence Platform can alert you to new COVID-19 trial activities in real-time and automatically match you to partners who need your unique capabilities immediately. It’s already tomorrow somewhere, so let us help you start today.  Learn More

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