MassDevice New Year’s Special | Don Hardison

Don Hardison
CEO, Good Start Genetics

Earlier this year, Don Hardison leveraged the knowledge gleaned from his years as Labratory Corp. of America’s (NYSE:LH) COO as an executive-in-residence with VC shop Flagship Ventures to dig into opportunies int he diagnostics space. He’s now at the helm of one of his finds, Good Start Genetics, which soon into his tenure landed an $18 million Series A round. The Boston-based company is developing a pre-pregnancy genetic test designed to screen for a panel of genetic disorders, including sickle-cell anemia and cystic fibrosis. Hardison told MassDevice at the time that Good Start will use the financing to commercialize the test, which he expects to hit the market some time next year.

Last week we asked Hardison for his input on the genomics space and the impact of a challenge to Myriad Genetics’ patents on a pair of genes linked to breast and ovarian cancer. Here’s his emailed reply, edited for grammar and clarity:

I think the role of the Food & Drug Administration in regulating diagnostic tests is one of the bigger issues broadly affecting genomics this year, and will continue to play a role until it’s resolved.

Also the situation around gene patents (i.e., the Myriad lawsuit) is obviously a big deal. Who knows how that will play out, but it’s certainly affecting diagnostic companies. Same thing for 2011, as there is uncertainty in what it could all mean.

Companies that own gene patents seem to be taking a very cautious view of going after companies who are clearly violating their patents.

Another interesting development is around the whole area of next-generation sequencing and the use of that technology for whole genome sequencing (and for more targeted uses, such as what we are doing).

Part of this is FDA-related, as the companies which have a direct-to-consumer strategy have come under close scrutiny.