Posts From the monthly archives: "January 2016"

Diagnostic tests with algorithms seem to slow review periods on average. Share this Image On Your Site <p><strong>Please include attribution to with this graphic.</strong><br /><br /><a href=’…(Read More)

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…(Read More)

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. The first quartile (bottom of box) Third quartile (top of box) The median (horizontal line within box) The mean (diamonds) Share this Image On Your Site <p…(Read More)

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.  Unfortunately this does little…(Read More)

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, which is what Amplion is all about. Good news: The…(Read More)

We are excited to be attending a full conference schedule in 2016 focused on conferences designed for the diagnostic , biomarker, biotech personalized medicine, biopharma and healthcare audiences. We are interested in sharing our core expertise in biomarker data applied to topics including: personalized medicine, biomarker intelligence, companion diagnostics and competitive intelligence.  Below you will find…(Read More)


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