$BNGO Reminder: "Approval" for a medical device is not like approval for a drug. With a drug, you need FDA approval after a series of clinical trials. Medical devices can be certified for diagnostic use based upon tests made in any of hundreds of CLIA certified labs. Such testing is now under way for Saphyr for diagnostic use in cancer and innate diseases. Some certification for Saphyr has already been achieved, e.g. by Praxis labs. Once certification for diagnostic use has been achieved by one lab, it can be piggy backed on by others. Certification of devices like Saphyr are much easier to achieve than is FDA approval for a drug. Bionano is currently working with quite a few CLIA labs to obtain certification via their LDTs (lab developed tests.) Insurance codes will follow certification. Our Alka Chaubey and Hannah Mamuzka are experts in getting that done. Management moving fast in the above areas.
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