Roche Leads The Way In Biomarker-Based Test Releases

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...

IVD Developer Vermillion Opens CLIA Lab

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...

IVD vs LDT Market Comparison:Key Findings

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...

Part 1. LDTs: A Market Perspective

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,...

Part 2. IVDs: A Market Perspective

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...

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