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Learning from failure: What Theranos, Interleukin Genetics, & Courtagen can teach us about IVDs

In the aftermath of the Theranos downfall, dozens of pundits have performed virtual autopsies of where CEO Elizabeth Holmes went wrong, generally highlighting a lack of full disclosure about the technology its labs were using. In the beginning of July, Interleukin Genetics announced that it was laying off more than half of its staff amid a decision to halt sales of its genetic test for periodontal disease risk. Just a few weeks later, Courtagen Life Sciences announced it would no longer offer its next-generation sequencing (NGS)-based tests for neurological disorders due to difficulties with reimbursement and the regulatory environment.

These three companies and others like them share a common thread: an (apparent) failure to plan appropriately for their IVDs from the beginning.

Developing and commercializing an in vitro diagnostic (IVD) is a complex enterprise involving numerous tasks accomplished by a variety of specialized and knowledgeable individuals. Generally, the process can be broken down into product concept development and validation, diagnostic development/engineering, regulatory requirements, market access planning, and commercialization planning and operations. Each of these overarching processes is similarly subdivided into tasks and deliverables. Importantly, while these are often thought of as discrete tasks, in reality they are significantly intertwined and overlap in time (or should be).

I think that the failures of Theranos, Interleukin Genetics, and Courtagen Life Sciences highlight mistakes that are made commonly by IVD companies and can serve as examples for companies focused on remaining relevant in the extremely competitive IVD industry.

The rest of this my piece is published here:

Sorry for the redirection, but since it is being published I want to make sure I point everyone in the right direction. If you do like the piece, please let me know here and I can write more on this topic or similar topics.