FDA has granted Acon Laboratories emergency use authorization for an over-the-counter COVID-19 test as the demand for diagnostics surges in the U.S. The federal agency has now authorized more than 400 COVID-19 tests and sample collection devices since March of 2020.
The San Diego, CA-based company said the Flowflex COVID-19 Antigen Home Test is a simple nasal swab test. It may be used for self-testing by individuals aged 14-years-and-older, or with adult-collected nasal swabs from children as young as 2-years-old.
“We believe at-home diagnostic tests play a critical role in the fight against COVID-19,”FDA’s Director Jeff Shuren, M.D. and J.D., wrote. “We will continue to offer support and expertise to help with the development of appropriately accurate and reliable tests, and to facilitate increased access to tests for all Americans.”
FDA said the authorization for the test could significantly increase the availability of rapid, at-home tests and is expected to double rapid at-home testing capacity in the U.S. over the next several weeks. FDA said Acon had plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022.
As of press time, Acon could not be reached for comment.
A report from Reuters noted there was a nationwide shortage of rapid tests as the Delta Variant rages on.
Another factor driving the increase in the demand for COVID-19 testing is President Joe Biden’s mandates that were announced early last month. One of the mandates would require companies with more than 100 employees to have unvaccinated workers tested weekly for the virus.
The demand is definitely having an impact on the diagnostic companies and labs alike.
LumiraDx’s Chief Product Officer Pooja Pathak, spoke about the surge and how the company was meeting the demand. The company, which recently went public through a special purchase acquisition corporation merger, said its current test strip capacity is 28 million increasing to 35 million to 45 million by end of year.
“We are seeing increased demand from existing customers as their testing needs increase and also new customers in cases where their current suppliers are unable to meet demand,” Pathak told MD+DI via email. “It’s difficult for any of us - whether we're in the diagnostics industry, healthcare administrators or policymakers - to really predict what's going to happen with the pandemic. However, it does seem clear that continued testing is going to be very important to getting us back to a new state of normal, to opening economies, to allowing us to control the spread, all keeping people healthy and safe. During this time, LumiraDx has been fortunate to be able to meet our customer needs and haven’t had customers on backorder. We have significant capacity to support expanded testing as needed.”
Pathak added, “over the last 18 months, LumiraDx as a company, and diagnostics as an industry, have done a lot of work to build up manufacturing capacity, to improve the supply chain, and to expand our product offering. This ‘crisis innovation’ is also making lab-style tests in the community more affordable and could transform wellness and public health long after the pandemic passes.”