78.5 F
San Fernando
Saturday, May 21, 2022

First Home COVID Test In Valencia

Digital diagnostics company Ellume Inc., an Australian company with U.S. operations in Valencia, developed the first at-home COVID-19 test approved by the U.S. Food and Drug Administration.Ellume’s test kit is priced at $30 and doesn’t require a prescription, great news for a populace facing stay-at-home orders and an overburdened health care system.“The world needs access to fast, affordable, easy-to-use home testing,” Dr. Sean Parsons, chief executive of Ellume said in a statement. “Ellume’s COVID-19 Home Test delivers this important first line of defense … enabling the U.S. to respond to the pandemic in its most urgent stage.”The company plans to scale up manufacturing this month to deliver millions of tests, roughly 100,000 per day. By mid-2021, Ellume expects to manufacture and deliver 20 million test kits to the U.S. market.Ellume has not announced which retailers will carry the test as of press time, but said shipments will begin to arrive in early January.The FDA on Dec. 15 issued an emergency approval authorization for the test on adults and children age 2 and older. Data submitted to the government entity showed Ellume’s test to be 96 percent accurate.

The company was able to fast-track test development with a $30 million grant from the U.S. National Institutes of Health Rapid Acceleration of Diagnostics initiative.“It’s all about catching people before they’ve had the chance to spread it to other people in their household or in their communities,” Parsons said in a subsequent recorded interview shared with the Business Journal. “The point of this testing is, while we’re looking to vaccinate the community, to enable as few people to get coronavirus and as few people to die as we possibly can, to minimize the impact of coronavirus.”Patients will need a smartphone to take this test, according to Ellume’s statement. The test analyzer connects to the user’s phone via Bluetooth and provides step-by-step instructions before displaying results.

The entire process takes about 15 minutes, Ellume staff said, and can be shared with local public health departments to make contact tracing faster and more efficient. Components include a sterile nasal swab, dropper, processing fluid and Bluetooth connected analyzer.

Ellume’s core technology uses ultra-sensitive optics, electronics and software for immunoassay reporting. Immunoassay is the procedure of testing for a specific antibody or antigen in the blood and other fluids, according to Lab Tests Online.“The core technology in the home COVID test has been a long time coming,” Parsons explained. “We founded Ellume in 2010 after the swine flu pandemic to create a breakthrough, high-performance diagnostics for influenza and other infectious diseases..”

Featured Articles

Related Articles