FDA Plans New Regulations for More Reliable Diagnostics

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On July 31st, 2014, the FDA announced that they would be taking two steps to ensure the reliability of diagnostic tests. First, the FDA has issued guidance on the development of in vitro diagnostic companion devices. These are tests designed to be used in conjunction with a medication to identify patients who may or may not benefit from the treatment. Secondly the FDA is notifying Congress of their intention to publish oversight framework for laboratory developed tests (LDTs).

The reasoning behind these two changes is to help bring diagnostic tests in line with similar FDA-approved products. The FDA has historically exercised discretion about these kinds of devices and tests, but as the technology grows, regulations must keep up. These new guidelines will also hopefully help stimulate early collaborations between laboratories and the FDA, which will help improve development and access of new therapies.

How does this affect Genelex and YouScript?

On the first point, the YouScript Personalized Prescribing software doesn’t count as an IVD companion device according to the FDA’s rules. IVD companion devices are designed to provide “information essential for the safe and effective use of a corresponding therapeutic product.” While YouScript is designed to optimize medication regimens, it is not essential for the use of any medications, nor is it linked to one specific medication.

On the second point, about LDTs, this would eventually affect Genelex DNA testing. Genelex DNA testing would indeed fall under the heading of an LDT (although the YouScript software itself does not). However, this does not mean that immediate changes are needed. The FDA has made it clear that the first five years of the new regulations will be spent regulating Class 3, high risk LDTs, mainly in the oncology sector. Genelex DNA testing would be considered to be lower risk, which means the laboratory has ample time to plan for this transition.

Furthermore, the FDA has made it clear that they will work closely with CLIA so accreditation for both processes can be done at the same time as often as possible. Genelex laboratory testing is CLIA accredited. Additionally, we have more strict documentation and oversight in place than other labs may as we are also CAP and NYSDOH accredited. This would make any additional information sharing requirements the FDA may have more easily done.

These new FDA requirements will not adversely affect Genelex DNA testing or the YouScript Personalized Prescribing System and will hopefully help spur greater reliability and collaboration in the industry.

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