By Manas Mishra
(Reuters) – Fluxergy Inc said on Thursday it had received an important quality designation from the European Union for its COVID-19 test, a promising sign as the California-based start-up still waits for U.S. authorization a year after filing the application.
The company, which received the CE mark, is now looking for partners to launch the product in the region and other markets that accept the quality clearance, Chief Executive Officer Tej Patel told Reuters.
But it is still actively pursuing emergency use authorization (EUA) in its domestic market for the product, a molecular or PCR test that can process results in an hour.
The company, which was formed about eight years ago and employees about 80 people, filed for an EUA with the U.S. Food and Drug Administration in March last year amid surging demand for COVID-19 tests.
The application was still stuck in the FDA’s backlog because Fluxergy never had a product launched in the market before, Patel said, adding that the agency was also inundated with different applications.
Since then, the United States has authorized several PCR tests, antigen tests which are typically faster but less precise than molecular tests, and antibody tests to measure immune response.
However, Patel said he believed the company’s product still has a place in the United States’ testing efforts.
“Most RT-PCR tests are still done in labs, so there is need for rapid testing for RT-PCR. So that’s why we’re not too worried.”
To scale up manufacturing, the company received a $30 million investment from the co-founder of Kingston Technology, a maker of computer memory products and the principal investor in Fluxergy.
The company said it had now expanded manufacturing capabilities for its testing system to up to 1 million per month.
(Reporting by Manas Mishra and Shariq Khan in Bengaluru; Editing by Maju Samuel)
