Six companies had their first biomarker-based tests cleared by FDA in 2013, and while they (and the tests they released) were quite diverse in many respects, company size is not one of them. Philips Healthcare is the one large company represented, and the remaining...
NanoString will utilize IP from a 20-gene expression assay developed by the Lymphoma/Leukemia Molecular Profiling Project (LLMP) to develop a companion diagnostic test to support clinical validation of Celgene’s REVLIMID®. NanoString could receive up to $45...
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...
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...
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...
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