Chart of the Week: Unique Biomarkers Used by Top Pharma

These are the drug developers using the largest number of unique biomarkers in their clinical trials, unique biomarkers being defined as those biomarkers that aren't being used by any other drug developers.

Chart of the Week: Algorithms Slow Test Review Period

Diagnostic tests with algorithms seem to slow review periods on average.  

[Infographic]: A Visual History of LDT Regulation

We've covered the LDT regulation evolution for some time now.  To give some perspective we've created the following infographic showing the history of LDT regulation.  To use it in your own content check out the code snippet below the infographic.  We only ask that you include attribution to ...

Chart of the Week: Test Approval - Experience Counts

The most experienced test developers get their tests through the process of FDA approval or clearance 70 days faster on average and 90 days faster on median.

Chart of the Week: Average Review Time for FDA Approved/Cleared Tests

The FDA review process has a major impact on the time-to-market for tests and, therefore, on diagnostic companies' willingness to invest in developing innovative tests for submission. The development of innovative diagnostic tests is critical to delivering on the promise of personalized medicine, ...

10 Diagnostics Innovators: Smaller Companies Are Leading the Way

As we have previously reported in this blog, innovation is not a major focus for many of the largest diagnostics companies.  With but a few exceptions, the focus for the largest companies tends to be on selling instrumentation and on developing “me-too” tests, which are low risk and high volume.  ...




Pharmacovigilance and Safety Biomarkers

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