It was with great anticipation and excitement that we received our Certificate of Compliance yesterday from the US Dept. of Health and Human Services Centers for Medicare and Medicaid Services. This, paired with our compliance letter from the State of Maryland, means we have been deemed a CLIA lab and can begin to offer our Clinical Exome test under CLIA guidelines. It’s been quite a journey to get here and everyone is quite excited to receive this designation and achieve this milestone.

When we set out to open our sequencing services back in 2008, we put some milestones in place to track our progress. The first was easy; could we build and operate a next-generation sequencing (NGS) lab and also offer Sanger sequencing services. Initially, as a products company that focused on Sanger sequencing, we thought that would be easy to stand up Sanger services as we slowly built our NGS pipeline and customer base. It was the first of many misconceptions that would unfold over the next three-plus years. We quickly found that the Sanger services market was quite mature and very hard to break-in. We had no customer base, no sample acquisition infrastructure and no economies of scale that would allow us to be competitive. In other words, we had no clue what we were doing while many others had it down to a science, if you’ll forgive the pun.

Fortunately, NGS as a service was just getting started and all the companies jumping in seemed to have as much (or little) knowledge as we did. We quickly abandoned our focus on Sanger (although we still offer it) and focused our attention on a burgeoning NGS market. We started out by building out what we felt like was, and still do today, a state-of-the-art facility and hiring top notch managers for both the wet lab and bioinformatics. They were able to build fantastic teams on the fly and we set off to build an offering to mirror our best in class consumables for Sanger sequencing.

Fast forward to the end of 2011 and we felt we had achieved an important milestone: a consistent revenue stream from NGS services focused in the research setting with a strong customer list and repeat business. This we felt was validation that our offering was strong. It was at the end of last year that we set out on our next milestone: achieving CLIA status. This we felt, was important in many ways, not just because we believe that NGS can be a powerful tool in the fight against genetic disease such as cancer or neurological disorders (to name a couple) but also because it was the natural evolution of our company’s mission and vision.

So today we get to celebrate another important milestone in the three-plus year history of our Services division. Everyone at EdgeBio deserves credit in some form or fashion for helping us to achieve this goal. And rest assured we will celebrate!

For me, I have already looked out into the next milestone: building a customer pipeline and delivering a product that people will want to refer and return to use.

CLIA #21D2039005 MD State License 1853

Best,

Dean