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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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While You Were Waiting...The $1,000 Exome.

It’s been quite some time since my last blog post. We’ve been rather busy over the summer, so let me fill you in on what has happened. At Edge, we have been diligently working on our CLIA certification and offering, with our latest test offering a CLIA exome on our Illumina HiSeq2000 platform using either the Agilent SureSelect capture or Roche Nimblegen capture. Over the coming weeks the staff at Edge will be releasing a series of blog posts relating to targeted resequencing methodologies. They will relate specifically to Project Design, Research & Clinical applications, “Tools of the Trade”, Data Delivery and then a summary “Cheat Sheet”. They will be information heavy, with lots of tables and data to digest, so try not to read them right after a large meal.

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A LIMS Case Study with EdgeBio and Genologics

Recently, we participated in a case study with Genologics.  The focus was on us, EdgeBio, a growing sequencing and bioinformatics services business. Given we work in an expanding lab environment that includes three different sequencing platforms and associated, highly configurable workflows - we needed something to solidify project management and organize sample data and metadata.

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