As of Friday, March 27th an Austin-based biotech firm, Luminex announced on that it has received emergency use authorization from the U.S. Food and Drug Administration for a new diagnostic test designed to detect the coronavirus.
This new test allows for up to 96 samples to be analyzed at a time, Luminex said they can differentiate COVID-19 from other illnesses like the flu and produce results in about four hours.
These tests are designed to be administered in a medical facility and requires the use of the company’s existing analysis machines in a clinical lab setting.
Under the emergency use authorization, the company said it is planning on manufacturing about 300,000 new tests on a monthly basis.
Under certain agency guidelines, the FDA is allowing emergency use authorization for unauthorized medical solutions to be utilized under certain agency guidelines when the country is facing major public health threats.
Last month, the FDA announced that it would consider emergency use authorization for all proposals involving diagnostic devices for the coronavirus. A similar policy was adopted in 2016 in relation to the Zika virus, according to the agency’s website.
“We are partnering with our customers at clinical laboratories to address the global pandemic, providing fast, reliable, scalable, multiplexed tests that can help stem the spread of COVID-19 disease, while also ensuring that our tests are cost-effective,” Homi Shamir, president and CEO of Luminex, said in a written statement.
Shamir hinted that Luminex was working with Chinese government officials to offer a diagnostics solution to China during the company’s quarterly earnings call in February.
He said the company, which has about 700 of its 1,300 employees based in Austin, made changes to its internal operations, such as increased shifts and about 20 new local hires, to develop and manufacture the new test.
“We immediately shifted resources from other developments into this area,” Shamir said.
Shamir said the company was able to shift its operations to focus on COVID-19 solutions thanks largely to a $642,000 grant that it received from the Biomedical Advanced Research and Development Authority at the U.S. Department of Health and Human Services.
The company said earlier this month that it was ready to submit two newly developed coronavirus diagnostic tests to the FDA for the agency’s emergency use authorization, and said four clinical laboratories — including Baylor Scott and White Health in Temple — have conducted testing using the new products.
Both of the new tests require the use of the company’s analysis machines.
Shamir said the company is planning to submit an application for emergency use authorization for its other test sometime next week.
That test could produce results in two hours, according to the company.
During a Thursday press briefing, Deborah Birx, the White House coordinator for the coronavirus response, said innovations coming from the private sector can significantly contribute to the country’s fight against the coronavirus.
“We continue to have these new platforms added for laboratory testing, and these become critical platforms for states that have very low rates and very low rates needed to test,” Birx said.
