NEW YORK ─ SDI Labs on Tuesday announced an agreement with medical supply firm Medi-Wheels Diagnostics for the manufacture and global distribution of SDI's over-the counter rapid antigen test kits.
Under the agreement, the antigen test kits will bear the Medi-Wheels Diagnostics brand name and be sold in packs of two.
Financial and other terms of the agreement were not disclosed.
The partnership enables Medi-Wheels to immediately distribute 150 million kits per month. The firm will increase its manufacturing capacity by approximately 750 million units per month over the next month, or so, and has a goal to reach 2 billion units per month by the end of the second quarter, Garden Grove, California-based SDI said.
Medi-Wheels has also committed $200 million to build a 200,000-square-foot factory in Dallas to produce 1 billion rapid test kits per month, SDI added.
Medi-Wheels, which offers a broad range of medical products from numerous manufacturers, provides PCR testing, and has approximately 2 million individuals enrolled in a weekly COVID-19 testing program for corporations, universities, and other organizations, SDI said.
SDI Labs noted on its website that it is awaiting US Food and Drug Administration Emergency Use Authorization for its antigen test.
In April 2020, it received FDA EUA for a PCR-based assay for the qualitative detection of a region in the SARS-CoV-2 ORF1a/b gene in nasopharyngeal or oropharyngeal swabs.