Variability in Reimbursed Amounts for Biomarker-Based IVD Tests

by John Audette | Nov 30, 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.

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.

FDA Finally Provides Better Evidence of LDT Risks

by John Audette | Nov 16, 2015 | LDT Regulation, News, Regulation

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.

Personalized Medicine Pipelines: AstraZeneca, Genentech, and Novartis

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 Scorecare Whitepaper here.

Upcoming Congressional Hearing on Lab Test Regulation

by John Audette | Nov 04, 2015 | LDT Regulation, News, Regulation

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).

CMS Plan for Test Pricing Seems to Favor Large Labs

by John Audette | Nov 01, 2015 | Marketing, News, Reimbursement

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.




Pharmacovigilance and Safety Biomarkers

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