NEW YORK, Aug. 19 (GenomeWeb News) - Nanogen disclosed in an SEC filing today that it has received a letter from the US Food and Drug Administration stating that it requires FDA approval to market its NanoChip microarray platform.
The warning letter from the agency's Office of In Vitro Diagnostic Device Evaluation and Safety, sent to Nanogen on Aug. 12 and available here, said that the company's "test system" is "adulterated ... for failure to obtain premarket approval and misbranded ... for failure to notify the agency of your intent to introduce the device into commercial distribution as required" by the FDA's 510(k) clearance process.
Though the FDA describes the communique as a "warning letter," Nanogen calls it an "untitled letter." An untitled letter is an informal, advisory communiqué and not quite as severe as a warning letter, which is also informal and advisory in nature. But warning letters are issued for violations of regulatory significance - offenses that may lead to agency enforcement action if not promptly corrected.
The Nanogen letter notes that the company's NanoChip Molecular Biology Workstation, NanoChip Microarray, and analyte specific reagents "appear from the information on your website to be marketed to work together as an integrated test system." This test system "is a medical device," according to FDA regulations, "because it is intended for use in the diagnosis of disease or other conditions," the letter stated.
"A review of our records indicates that you have not obtained clearance or approval for this test system as a whole or for the components separately," the letter said.
The FDA also cited "contradictory statements" in Nanogen marketing materials that "suggest that these products are intended for research use, while others indicate that they are intended for use in clinical diagnostic applications."
The company "appears to be suggesting that its NanoChip System comprises research-use only devices," but "it is not apparent that Nanogen is complying with the requirement applicable to research-use only in vitro diagnostic devices," FDA said.
The agency noted in the letter that the NanoChip platform "does not appear" to qualify as a class I system, which would exempt it from the premarket approval requirement.
FDA has requested that Nanogen respond within 30 days of receipt of the letter.
Nanogen said in its SEC filing that it believes its products "comply with the FDA requirements and we intend to provide a response to OIVD in a timely manner."
The letter comes to Nanogen around two years after the FDA asked Roche why it believed at the time that its AmpliChip product can be marketed as an ASR. The eventual result of that letter was the decision by Roche to forego its original plan to release the product as an ASR and instead to seek FDA clearance for the AmpliChip as an in vitro diagnostic. The FDA cleared the AmpliChip as an IVD in January.