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10 Diagnostics Innovators: Smaller Companies Are Leading the Way

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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 to advance personalized medicine.

Fortunately, however, there are some diagnostic companies willing to take risks to develop cutting edge tests that move personalized medicine forward.  This post is focused on these companies, and the goal is to recognize them for their willingness to innovate.

We decided to update our analysis of the number of novel biomarkers that have been released in FDA-cleared and approved tests over the last 12 years, and to look at the companies that developed these innovative biomarkers to identify the leaders.

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Interestingly, the majority of the leaders are smaller companies.  Among the largest diagnostics companies globally, only Abbott Diagnostics and Roche Diagnostics show up on the list.

Nanostring tops the list in terms of total number of new biomarkers released, but all are in one panel for prognosing breast cancer.  The company that has been the most consistently innovative is tiny Kronus out of Idaho, which has developed five new diagnostic biomarkers over the last 10+ years, and which has never gone more than three years without releasing a test with a novel biomarker going back to 2004.

Inova, MBL, Exact Sciences, and Astute Medical are all small companies that have released two or more novel biomarkers into the healthcare system over the last decade, and they are being rewarded for being innovators.  The diagnostics industry is starting to follow the trend in pharmaceuticals, whereby the large companies license in or acquire the innovative products developed by smaller companies.

Astute Medical is an excellent example of this.  Astute developed an assay for acute kidney injury which uses two novel biomarkers, and Astute has begun signing lucrative licensing agreements with large diagnostic companies including Ortho Clinical Diagnostics and bioMerieux.

It will be interesting to see if this trend continues, and if the smaller companies continue to drive innovation.

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