Obtaining Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA)
A Customer Success Story.
What began in 2013 as a small toxicology laboratory founded by healthcare providers and professionals in Indiana quickly expanded into a state-of-the-art toxicology and molecular biology facility. Patients Choice Laboratories was founded by experts who collectively have over 60 years of laboratory and healthcare experience. They could not have known it then, but their expertise would one day be called upon as they find themselves at the epicenter of the state of Indiana’s response to a global pandemic.
When the COVID-19 pandemic reached Indiana, Patients Choice Laboratories was not sure whether to pursue COVID-19 testing. When it was announced in May that Eli Lilly and Company would cease development of COVID-19 testing in the state of Indiana, Patients Choice Laboratories realized the critical need to bring in authorized testing for the public. They began investigating the quickest route to ascertain an Emergency Use Authorization (EUA) from the FDA for COVID-19 testing.
The most vital step in successful and repeatable COVID-19 testing is the isolation of high-quality SARS-CoV-2 RNA from patient samples. Due to the massive scale of testing necessary, high throughput processing products and procedures, such as kits and automation, would be needed for successful RNA isolation. Jerome Nypaver- Director of Laboratory Operations at Patients Choice Laboratories – began looking at industry giants who already had EUA- approved RNA isolation kits and methods. Mr. Nypaver thought a straightforward approach to gaining the EUA for Patients Choice Laboratories would be to adopt the same kits and methods as those larger companies. However, these groups could not provide them the supplies and support needed due to the worldwide demand for viral RNA isolation kits.
Nypaver recalls, “We went to [Company A] … and they said, ‘no, sorry we can’t help you’… We went to [Company B] …and they said, ‘you know, we have stuff but it’s on backorder. Plus, it’s coming from Germany… good luck’.”
Nypaver, faced with gridlock and frustration, approached Omega Bio-tek – a company they use for other nucleic acid extraction kits. Omega Bio-tek had recently announced the launch of its Mag-Bind® Viral RNA Xpress Kit (M6219-2304) to address the increased demand and shortage for exceptional high throughput purification of viral RNA. Omega Bio-tek assisted Patients Choice Laboratories with scripting and optimization utilizing the new kit on a Hamilton Microlab® VANTAGE automated liquid handler. With this configuration, Patients Choice Laboratories was able to process 384 patient samples, or four 96-well plates, in 75 minutes.
“Omega came through in making sure we have consistent supply. We ended up being one of the only places in the state of Indiana who were consistently having the ability to extract…consistently running thousands of samples a day,” said Jerome Nypaver, Director of Laboratory Operations, Patients Choice Laboratories.
On August 27, 2020, the U.S. Food & Drug Administration (FDA) granted patients Choice Laboratories the Emergency Use Authorization (EUA) they had been working hard to secure.
Patients Choice Laboratories needed to quickly and efficiently obtain Emergency Use Authorization from the FDA to provide coronavirus disease 2019 (COVID-19) testing. They needed a supplier that could reliably deliver viral RNA extraction kits for their COVID-19 testing method. Major suppliers denied Patients Choice help because they lacked inventory due to mass disruption in global supply chains.
“The biggest obstacle was there were no extraction kits, there were no plastics, there were no KingFisher’s ™, there was nothing that was like a KingFisher- there was nothing out there…” said Jerome Nypaver, Director of Laboratory Operations, Patients Choice Laboratories.
Omega Bio-tek supplies, and continues to supply, Patients Choice Laboratories with much-needed RNA extraction kits, allowing them to consistently run thousands of samples per day. Omega Bio-tek worked with Patient’s Choice Laboratories to script and optimize the Mag-Bind Viral RNA Xpress Kit on a Hamilton Microlab® VANTAGE to meet their high-throughput, high-quality viral RNA extraction requirements for COVID-19 testing. Patients Choice was granted the Emergency Use Authorization (EUA) by the FDA.
“Omega was there when no one else really could be there. The flexibility… the ease… made it an easy option for us to ultimately go and get our own FDA EUA approval with the Omega kit,” said Jerome Nypaver, Director of Laboratory Operations, Patients Choice Laboratories.
Patient’s Choice Laboratories is one of 15+ laboratories that have been granted EUA by the FDA using Omega Bio-tek’s kit.