The lab I work for purchased a new automated diagnostic machine about a year ago and I had the luxury of validating the device for use. It is called nanoString DX digital analyzer and prep station, the test is called Prosigna and it is a prognostic for the recurrence of breast cancer. The most time consuming part was developing the required Individualized Quality Control Plan (IQCP). Normally you would just follow the regulations for quality control provided by CLIA, CAP, CLIS, FDA, etc. which would consist of the usual controls, lot to lot testing, and accurate record keeping, but in this case the device ran off of kits that had built in controls and the machine itself uses a proprietary algorithm that will either confirm or deny the test, if it is confirmed the results will print out but if the control is denied the results will not print out. The device is 510(k) FDA approved. The problem I ran across was that NJ requires strict quality control documentation and the fact that the algorithm is proprietary the company would not release the results from the controls to the user. All I needed was to show documentation that the controls passed, but the report that prints out only gives a score pertaining to the Prosigna test. I tried talking to the company and they were adamant about not releasing the control data, the only way around it was to create the IQCP which is an extensive document detailing how we would be able to maintain quality control standards for the high complexity test. The IQCP had to be approved before we were able to run tests. In order to save time and money, for non-STAT cases the solution was to receive specimen Saturday-Wednesday at noon, run all samples and controls on Wednesday, and release results on Friday. For STAT cases controls will be run when case is received. The problem with this “solution” was that the kits are expensive and having this new way of running controls wastes an entire kit. Kits include all reagents, plastics, probes, and cartridges. This small detail forces the company to buy extra kits they would not need to buy if they were located in a different state. This continues to be such a hassle and I’m sure that if the company had to do it again they would just go with the competitor Oncotype DX because their system is easier for the lab to get validated and would not have to spend extra money just to run the necessary controls required for NJ state.

3 day turn around time PER KIT:
Day 1 – Tissue Macrodissection and Digestion/Incubation
Day 2 – RNA Isolation and Probe/Incubation
Day 3 – Digital Analyzer and Report release

Controls can be run starting from the end of Day 2 – Probe/Incubation.

The question I propose:
Should a medical device company worry about the regulations required of labs of individual states if they are going to be selling the device in those states? Keep in mind that the above device is 510(k) FDA approved and the only restriction was that the necessary control data is considered proprietary and not released to the user, a crucial quality control problem for the lab.