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Responding to FDA s Warning, Nanogen Promises to Settle Dispute in September

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Nanogen officials have responded to an FDA warning letter that criticized the firm for apparently marketing its Molecular Biology Workstation without the requisite FDA approvals by pledging to work with the agency to resolve the situation.

The discussions between Nanogen and the FDA are not likely to affect the company's ongoing plan to release its NanoChip 400 System into the same lab market that the FDA said Nanogen's Molecular Biology Workstation is being marketed to improperly.

"We intend to work with the FDA to explain our position and we will modify our marketing or the wording of our website if it is jointly determined to be misleading," Nanogen's chief financial officer Robert Saltmarsh wrote in an e-mail to BioArray News last week. "We have an ongoing dialogue with the FDA and take compliance and the FDA's opinions seriously."

Steven Gutman, director of the FDA Office of In Vitro Diagnostics, which issued the warning letter Aug. 12, declined to discuss the details of the case in an e-mail exchange with BioArray News' sister publication Pharmacogenomics Reporter, but said that "most companies work with FDA to remedy outstanding issues and after informal or formal interactions in most cases these are resolved."


"We have an ongoing dialogue with the FDA and take compliance and the FDA's opinions seriously."

If Nanogen and the FDA don't see eye to eye, Gutman said that the federal body "has a variety of tools that can be applied to encourage conformance with regulations and statutes. Besides warning letters, these tools include seizures, injunctions and civil money penalties," he said.

Also unanswered is the question of the two groups' disagreement on whether the letter Nanogen received is an "untitled letter," as Nanogen stated in an SEC filing last week, or a more serious "warning letter," as Gutman told BioArray News in an interview this week, and as the top of letter itself reads.

"A warning letter tends to be a little more formal than an untitled letter, but they both are considered prior notice that the FDA wants to engage in dialogue with a firm," Gutman said.

Gutman also declined to discuss what may have prompted the letter from the FDA, especially since Nanogen's system has been on the market since 2001.

'Warning Letter'

Nanogen last week disclosed to the SEC that it had received a letter from the US Food and Drug Administration chiding it for the way it has been marketing its 4-year-old NanoChip Molecular Biology Workstation.

The warning letter from the agency's Office of In Vitro Diagnostic Device Evaluation and Safety was delivered to Nanogen on Aug. 12 and called the company's test system "adulterated ... for failure to obtain pre-market 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.

Specifically, the FDA took issue with the fact that some materials on Nanogen's website described the firm's workstation, NanoChip microarrays, and analyte specific reagents as tools for use in clinical diagnostics.

These products "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 pre-market approval requirement. The FDA requested that Nanogen respond within 30 days of receipt of the letter.

In its SEC filing, Nanogen officials denied any wrongdoing, but pledged to work with the FDA to resolve the matter.

The letter does come at a time when Nanogen is having more interaction with the FDA as it prepares its NanoChip 400 System for commercial release later this quarter (see BAN 8/10/2005). The 400 System will be for research use only until it receives FDA approval, which the firm anticipates could occur next year.

"The [NanoChip 400] is an open platform [system] that can be used in both the research market and clinical diagnostic markets," Saltmarsh said last week.

"FDA approval would broaden it to the clinical diagnostic market so we have planned to obtain FDA clearance. We'll determine a timeline and the specifics for FDA marketing clearance of the [system] after we respond to the agency's current questions," he said.

Gutman said that the current issues would not affect the pre-clearance work.

While Nanogen will seek clearance for the NanoChip 400, Saltmarsh said it will not seek FDA approval for the NanoChip Molecular Biology Workstation.

"The MBW has overwhelmingly been sold into the research market so seeking FDA approval of this is unlikely," Saltmarsh said.

In an interview with BioArray News last autumn, Nanogen CEO Howard Birndorf contrasted the two systems. "The molecular biology workstation was never built with the clinical lab in mind," Birndorf said. "It's being used in clinical labs, [but] it was built for the research market. [The NanoChip 400] was built with the clinical research/diagnostic lab in mind" (see BAN 11/3/2004).

The MWB was designed for high-throughput experiments, Birndorf explained, while the NanoChip 400 would allow users to tailor lower-throughput specific assays.

Still, Nanogen isn't the first company with an array-based product to run afoul of the FDA.

Nanogen's letter comes approximately two years after the FDA asked Roche why it believed at the time that its AmpliChip product could 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 approved the AmpliChip as an IVD in January (see BAN 1/5/2005).

The FDA's Gutman recommended that companies with similar products should "should review the ASR regulations and if they have questions about conformance with these, contact the FDA."

— Justin Petrone ([email protected])

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