EDITOR'S PAGE
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This legislation represents a major triumph for the IVD industry. For a long time, clinical laboratories have taken away business from IVD manufacturers by developing and performing home-brew tests without undergoing the same regulatory processes as manufacturer-developed IVDs. The bill levels the playing field by making labs as accountable as IVD manufacturers.
Since labs that develop home-brew tests would be considered manufacturers under this bill, they would be required to comply with manufacturing standards, such as FDA’s quality system regulation (QSR). Even though the bill exempts FDA from conducting biannual inspections of such labs’ facilities, this exemption would not relieve the labs of their responsibility of meeting the requirements. Labs would have to be as compliant to QSR as all other manufacturers, especially under the watchful eye of the IVD industry.
The bill would also require labs to submit information regarding the analytical and clinical validity of their home-brew tests, which FDA would review and compile in a database. If the data do not demonstrate such validity, labs would have to start over and submit a formal 510(k) or PMA in order to gain market approval for their home brews.
While the IVD industry has been calling for such regulation of home-brew tests, this bill could create side effects that could negatively affect the IVD industry. For example, FDA could end up conducting two full evaluations for all home brews: a first review of the database to determine analytical and clinical validity, and a second review of a lab’s 510(k) or PMA. This double-review framework would place enormous burdens on FDA, bog down the entire premarket review process, and stall market entry of other IVDs.
Of course, such concerns could be moot. Labs would have to start spending an inordinate amount of time, energy, and money to comply with QSR and submit a 510(k) application. Once labs realize the enormity of these tasks, many of them may decide to discontinue developing their home-brew tests and instead purchase them from IVD manufacturers.
But there is a potential downside to all of this. If labs that develop home-brew tests decide to discontinue doing so, innovative, cutting-edge tests for certain rare diseases will no longer be available to patients. In order to rectify this situation, FDA could consider implementing provisions similar to the Humanitarian Use Device Regulations.
While the Kennedy bill is a step in the right direction, many issues such as the review process of labs’ home-brew tests and the availability of tests for uncommon conditions still need to be resolved. IVD manufacturers should contact their representatives in Congress to ensure that amendments addressing these issues are adopted into the Kennedy bill. Only by doing so will this vital piece of legislation truly respond to the needs of the IVD industry and labs, and the patients that both of them serve.
