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CLIA Inspection: A highly anticipated day

As many of you know, we received our CLIA designation back in March of this year for our first CLIA test, the Clinical Exome Test. While this is not a catchy name with a clever acronym, it does a pretty good job of conveying exactly what the test is, I believe. What you may not know is that you do not get inspected by State regulators before you receive your CLIA and State certificates, you get audited afterwards. So, while highly confident in our data submission package for CLIA application, until you get audited, there is still a bit of doubt as to whether you are truly good enough. Similar to asking someone to marry you, when proposing, generally you are pretty confident in the response. But there is always that little bit of doubt…

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Tour EdgeBio Labs

Here at Edge we have designed our next generation sequencing lab from the ground up, with the goal of providing top quality, scalable services in a highly controlled environment.  We utilize the latest technologies in order to maintain our position at the cutting edge of next generation sequencing.  This virtual tour will take you through our various laboratories to give you a look inside our operation.  In each room there are clickable icons that provide details about the various instruments and products that we use.  Please take a minute to look around and see what we have built.

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Clinical Exome Sequencing Services for Labs and Hospitals for in-House Interpretation

We would like to thank Genomeweb for their recent articles regarding the announcement of our CLIA status. If you missed the articles from Genomeweb you can view them here:  Clinical Exome Sequencing and EdgeBio Recieves CLIA Certification

Request a Quote for your Exome Sequencing Project

 

A few weeks ago we received our CLIA certification for next generation sequencing and will offer clinical exome sequencing for large labs and hospitals that can do their own in-house analysis. We will supply aligned sequencing data and leave the interpretation to the customers themselves.

Recieving CLIA Status

EdgeBio CLIA labIt 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.