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

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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.

We are currently in the process of negotiating and finalizing agreements with several labs to provide the sequencing portion of their clinical exome tests.  “What we’re not going to do is have the capability to provide genetic counseling or the ability to interpret data to make clinical or therapeutic recommendations,” CEO Dean Gaalaas said.  "Say you have a genetic group or a lab group that has that capability but doesn't have access to a sequencer, or doesn't have bioinformatics. They want to be able to send out samples, get exome data and have an aligned file. But [they] know how to mine [the data] and when [they] see mutations, [they] know how to deliver that result either back to the attending physician or to the patient themselves," he explained.

We can provide services on multiple platforms including SOLiD and Ilumina HiSeq. However, we anticipate that the majority of our clinical sequencing will be done on the Illumina  Gaalaas stated “I think it's fair to say that the market has spoken, particularly with exome sequencing, and the norm is doing paired-end 2x100 base pair sequences, and unfortunately the SOLiD platform just doesn't have that chemistry availability."

As we move forward, EdgeBio will be focused on building relationships with labs looking for clinical sequencing data and have the ability to interpret and make decisions based on that data.  In addition we will be looking to expand our clinical sequencing capabilities and offer new services based on which areas of need develop in our customer base.  Managing Director of GeneDx, Sherri Bale, will serve as the clinical laboratory director for EdgeBio.