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.

IVD Developer Vermillion Opens CLIA Lab

by John Audette | May 27, 2014 | Marketing, Test Developers, News

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 ...

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:

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 developers of FDA-cleared and approved ...

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, a comprehensive analysis of growth of ...

AstraZeneca Reveals All; Provides Detailed Support for Biomarker Use In Clinical Trials

AstraZeneca has just published an incredibly revealing and useful paper in Nature Drug Discovery, in which a thorough analysis of AZ's clinical trial successes and failures is presented.

Biomarkers and Commercial Strategy: Comparing The Three Leading Breast Cancer Panels

In the course of reviewing the new targets that made their way into FDA-cleared tests for the first time during 2013, one of the more interesting examples was the Prosigna® panel released by Nanostring last year.

Multi-Biomarker Tests Dominated 2013 FDA Clearances

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.




Pharmacovigilance and Safety Biomarkers

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