The impact of the COVID-19 pandemic has reached into quarters that are not historically problematic for makers of diagnostics, including China’s import and export practices for test kits. According to one caller on an FDA diagnostic town hall, export officials in China have a blacklist and a whitelist for test kits, but there is some dispute as to whether kits that are eligible for distribution in the U.S. can get off the blacklist unless that kit is specifically called out via the emergency use authorization (EUA) program.

The question of China’s customs practices arose during the FDA’s June 10 town hall for testing for the pandemic, during which a caller said authorities in China have recently developed a blacklist and a whitelist for test kits for export. Items on the blacklist cannot be exported unless that kit is explicitly listed under the EUA program, the caller asserted, while items appearing on the white list are not subject to the same hold-ups. The FDA recently delisted a number of serological tests that do not hold up to performance standards, possibly an explanation for the action on the part of Beijing’s export authorities.

The caller said the problem is the whitelist is not comprehensive, particularly with regard to kits that are not formally named under an EUA. Distributors are having a problem obtaining those kits, and Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said the agency is aware of the existence of the lists. He said there are FDA staff members with a working knowledge of Beijing’s policies in this regard, and who have “tried their best and made some progress” on ensuring the process does not hamper legitimate imports.

A manufacturer can get on the whitelist while they are still in development, but Stenzel said developers who want to avoid such an impasse might want to do the validation testing in the U.S., “which of course we would support.” There is a limit to the number of kits a developer can ship at a given time, but if a test is on the FDA’s notified list and can be marketed in the U.S., that test maker should contact the agency if they encounter problems at export from China. Stenzel vowed to take such issues up the organizational chart at the FDA.

Stenzel said he has some information suggesting developers can get on the whitelist despite not being listed under the EUA program, adding that while he cannot speak to the export vetting process used by Beijing, the FDA is supportive of tests that have been notified.

60-fold increase in some applications

Stenzel was speaking on the 12th town hall, for the COVID-19 testing program, and noted that his center’s virology branch has received “an unprecedented number of submissions,” amounting to 60 times the normal volume. The agency is prioritizing reviews for some categories of products and test types, among which are home sample collection kits and home testing kits. High-throughput testing systems are also prioritized, thanks to the fact that some of these can process 200 or more patient samples in a single run. “Those applications have significant public health importance” due to the need to increase the volume of test runs, he said, adding that point-of-care tests are also still a priority.

To date, the saliva tests the FDA has seen have exhibited variable performance parameters, and thus the agency has not yet been able to authorize one due to inferior performance. Stenzel said the required performance parameters are comparable to those required for tests employing conventional swab samples. High-complexity labs can validate sample-type specimens for tests that have already been authorized, and a modification to saliva-based test is acceptable so long as the validation data are solid. Stenzel said the agency encourages developers to submit the data for these tests for the EUA program, but noted that high-complexity labs are not required to so per existing policy.

The FDA is continuing to work on specific recommendations for developers for in-home testing, but Stenzel said the agency is willing to engage with developers now. There are several parties that have demonstrated an interest in at-home testing, but the agency is particularly concerned that all aspects of this approach to testing are accurate, including reading and interpretation of results. He said telehealth programs might aid the effort to ensure users appropriately use such a test.

DoJ announces first arrest for COVID false claims for testing

The U.S. Department of Justice announced it has charged the president of a medical technology company in California for taking part in schemes to commit health care fraud in connection with more than $69 million in false claims for testing. The complaint against Mark Schena, president of Arrayit Corp., of Los Altos, Calif., says that this is the first criminal securities fraud prosecution by the department related to the pandemic.

Schena is alleged to have touted Arrayit as the only lab in the world that offers “revolutionary” microarray technology that allowed the company to test for allergens and for the SARS-CoV-2 virus on a drop of blood that is 1/250,000 the volume needed in the now-discredited Theranos testing system. Starting in 2018, Schena and others began paying kickbacks and bribes to patient recruiters and doctors for referrals for unnecessary allergy tests.

Schena and his co-conspirators added COVID-19 testing to the list of fraudulent tests, and then commenced with claims about the offering, which led to a doubling of the company’s share prices. The press release does not indicate that this was a qui tam action.

No Comments