Posts From the monthly archives: "May 2014"

In a continuing effort to refresh the content of our research report, Commercial Trends for Biomarker-Based IVD Tests, we have begun to look at the companies that had tests cleared by 510(k) or approved by PMA during 2013. Roche led all companies in total number of tests released during 2013, when combining the…(Read More)

Vermillion, developer of the 510(k)-cleared OVA1 test, has recently opened its own CLIA lab, called ASPiRA Labs (source: company press release). The lab will initially focus on providing the OVA1 test, but will eventually “expand to other gynecologic conditions with high unmet need.” Did Vermillion learn some hard lessons from getting clearance of…(Read More)

We conducted analyses of the revenue and market capitalization of publicly-traded IVD and LDT companies (see below). Here are the key takeaways and assumptions drawn from this comparison: – Dx product sales (IVD) grew at 3 times Dx service sales (LDT) from 2011-2013. – Specialty LDT companies are valued for current revenue; Specialty IVD companies…(Read More)

We have been discussing for some time in this blog the commonly held belief that biomarker testing is primarily being done using laboratory-developed tests as opposed to FDA-cleared and approved tests. There hasn’t yet been conducted, at least to our knowledge, a comprehensive analysis of growth of LDT developers that provides solid…(Read More)

In a previous post we looked at revenue growth for publicly-traded LDT developers, as the first step in attempting to better understand the market size and segmentation for LDTs. In this post we have pulled together some sales information for publicly-traded developers of FDA-cleared and approved tests for comparison. For clarity, we…(Read More)

In last year’s edition of our report, Commercial Trends for Biomarker-Based IVD Tests, we predicted growth in multiplex biomarker tests, and we can now report that tests cleared during 2013 support this prediction. Over half of all biomarker-based tests cleared by 510(k) during 2013 measure more than one target, and the…(Read More)


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