Omega Bio-tek announces collaboration with Ipsum Diagnostics in the fight against COVID-19. Omega Bio-tek will supply its Mag-Bind Viral DNA/RNA 96 Kit as a vital element in Ipsum Diagnostics’ approved RT-PCR-based SARS-CoV-2 assay. The US Food and Drug Administration granted Emergency Use Authorization (EUA) to Ipsum Diagnostics for RT-PCR-based SARS-CoV-2 testing on April 1, which includes the Mag-Bind Viral DNA/RNA 96 Kit for viral RNA extraction. The Georgia Department of Health also issued an agreement with Ipsum Diagnostics to expand its state-wide testing utilizing the approved assay.
Ipsum Diagnostics recognized Omega Bio-tek when other nucleic acid purification kit manufacturers could not supply a viral RNA extraction kit due to the high demand worldwide. The urgency in obtaining a sustainable RNA extraction kit was critical to validate the workflow for the FDA approval.
“Ipsum Diagnostics reached out to us with interest to purchase our kits on a Saturday, and we were able to process the order, provide robotic scripts, and offer pickup at our location that same day. We had already increased our manufacturing production of the magnetic beads and our Mag-Bind Viral DNA/RNA Kit, which included working weekends,” said Travis Butts, Vice President of Omega Bio-tek. “We believe our ability to timely provide a reliable viral RNA purification solution was essential in giving Ipsum Diagnostics the ability to speed up their validation process with the FDA.”
Foreseeing the shortage of RNA extraction kits worldwide, Omega Bio-tek ramped up production of the Mag-Bind Viral DNA/RNA 96 Kit during the beginning of the pandemic. Currently, the company has increased production to provide reagents for 2 million patient tests per month in an effort to support several Laboratory Developed Tests (LDTs) globally, with anticipated further increase in production to 6 million tests by the middle of May.