Takara Bio’s technology enables Indiana University of Pennsylvania and Indiana Regional Medical Center to develop a faster COVID-19 test for rural communities

Takara Bio USA, Inc., a wholly owned subsidiary of Takara Bio Inc., is collaborating with Indiana University of Pennsylvania (IUP), and Indiana Regional Medical Center (IRMC) to enable better and faster COVID-19 testing for rural communities in the United States and around the world.

Many rural communities have been struggling to keep up with the demand for COVID-19 testing. Although medical and laboratory personnel are doing their best to process samples, current detection protocols are expensive and slow, and they can expose laboratory personnel to the novel coronavirus (SARS-CoV-2). Furthermore, underserved communities have been hit especially hard by supply chain issues with sample processing components.

Stakeholders at IRMC and IUP initially identified a critical need for increased COVID-19 (SARS-CoV-2) detection in their community. As a result, Dr. Narayanaswamy Bharathan, chair of IUP’s Department of Biology, began COVID-19 testing at IRMC in May 2020 and has since processed more than 15,000 COVID-19 samples.

In July 2020, Dr. Bharathan finished developing a new testing protocol that incorporates RT-qPCR reagents developed by Takara Bio Inc., a world leader in biotechnology research and development that offers a host of life science research solutions, including reagents for detecting SARS-CoV-2 that have been used in multiple lab-developed COVID-19 tests permitted under FDA Emergency Use Authorizations.

“The IUP and IRMC partnership is extremely important for our community, and we are very pleased to see this partnership extended with Takara Bio USA,” IUP President Dr. Michael Driscoll said. “It’s very gratifying to be part of an initiative that has the potential to impact communities throughout our nation and our world. On top of their commitment to excellence in the classroom, our faculty are incredible researchers, many with very meaningful and deep connections to companies and scientists all over the globe who are doing cutting-edge work and study.”

Bharathan has a long-standing relationship with Takara Bio USA, including using the company’s RT-qPCR-based detection products at IUP for teaching and research.

Takara Bio’s PrimeDirect™ Probe RT-qPCR Mix makes it possible to bypass a time- and labor-intensive step in the current gold-standard RT-qPCR detection method: extracting viral RNA from nasal fluid samples.

Takara Bio’s extractionless method also minimizes reagent usage and supply chain issues, and importantly, decreases technicians’ exposure to the live virus during the RNA purification step—all while maintaining high accuracy and sensitivity of detection. The Takara Bio reagents and protocol significantly reduce the time to results.

The three-step extractionless PrimeDirect Probe RT-qPCR protocol allowed faster, cheaper, and higher throughput testing for COVID-19 in rural communities.

“What used to take five hours to get results from 50 samples now takes 45 minutes, and it reduces the chance of error because samples are handled less and the opportunity for contamination is reduced,” Bharathan said. “There’s also no need to stabilize patient swab samples in transport media, so that reduces costs and time.

“This short turnaround time is very good news for rural America, and for countries that desperately need testing but are limited in financial resources,” Bharathan said. “In addition to finances, there are supply chain issues related to getting the reagent needed in traditional tests to the testing facilities. Our extractionless protocol removes those challenges,” he said.

Dr. Hilliary Creely, interim dean of IUP’s School of Graduate Studies and Research, has been steering this effort, guiding the logistics and legalities related to the IRMC partnership.

“This has been a Herculean effort, and the workers in the project have been inventive and flexible,” Creely said. “When issues have surfaced, we have addressed them together. IUP has been a source of the equipment that the IRMC lab has needed, Takara Bio ensures a steady supply of the reagents, and IRMC remains key to the success of this initiative, especially with IRMC’s CLIA certification that allows them to perform testing on patient samples.”

Takara Bio USA plans to hold a virtual seminar during which Dr. Bharathan will share the collaboration’s successes with other researchers and biomedical professionals.

“This partnership has been a vital piece in our ability to care for the region. The ability to find resources and brilliant minds in our own backyard is what makes this community truly great,” President and CEO of IRMC Stephen A. Wolfe said.

“While COVID-19 vaccines are a welcomed light at the end of the tunnel, we know it will take some time until we can vaccinate enough people to reach herd immunity,” President of Takara Bio USA Carol Lou said.

“Going forward, COVID-19 surveillance will remain essential to monitor and prevent sudden outbreaks. Rapid, direct detection on a large number of samples lowers the burden of testing, making it easier for everyone, especially those in underserved communities, to remain safe. Our collaboration serves as a model for how we can scale up these efforts in similar communities worldwide.”