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...
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,...
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...
This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Cookie settingsACCEPT
Privacy & Cookies Policy
Privacy Overview
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.
