Indiana University of Pennsylvania, Indiana Regional Medical Center, and Takara Bio USA, Inc., a wholly owned subsidiary of Takara Bio, Inc., are collaborating to bring better and faster COVID-19 testing to rural communities in the United States and around the world.

Stakeholders at IRMC and IUP identified a critical need for increased COVID-19 (SARS-CoV-2) detection. As a result, Narayanaswamy Bharathan, chair of IUP's Department of Biology, began COVID-19 testing at IRMC in May 2020, using IUP equipment in an IRMC laboratory.

He has completed testing of more than 15,000 COVID-19 samples since that time.

Narayanaswamy Bharathan in a laboratory

Since May 2020, Dr. N. Bharathan, chair of IUP's Department of Biology, has completed testing of 15,000 samples for COVID-19 at Indiana Regional Medical Center.

In July 2020, Bharathan finished developing a new detection protocol that incorporates RT-qPCR reagents developed by Takara Bio. The aim of the three-way collaboration is to share the new testing protocol with rural medical centers, increasing the accessibility and speed of COVID-19 testing in underserved areas.

Takara Bio is a leading provider of biotechnology equipment and life science 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. Together with its subsidiaries, Takara Bio is committed to preventing disease and improving the quality of life for all through the use of biotechnology.

“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 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,” Driscoll said.

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.

“The IUP/IRMC/Takara Bio USA collaboration is all about working together to advance COVID-19 testing in rural America, in communities that have financial challenges, and in countries that are in desperate need,” Bharathan said. “This is not just a Pennsylvania pandemic, or an American pandemic; it is a global pandemic, and this local work will help people all over the world.”

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.

“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.

Since July, Bharathan has tested more than 10,000 samples with the Takara Bio's “extractionless” process and has provided important information to the company on testing in rural settings.

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.”

“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 at 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,” Lou said.

Bharathan's work at, and with, IRMC, in addition to supplying local testing and same-day results, has also led to important research data that can be used moving forward related to microbial genomics, Bharathan said.

In addition to his testing work, Bharathan has trained three laboratory technicians to work at IRMC with the IUP equipment.

“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.

Bharathan is authoring a paper about his work and the resulting findings for international scientific journals. Takara Bio USA has also invited him to share his successes with other researchers and biomedical professionals through a virtual seminar, with the goal of getting the message out to other medical centers in other rural parts of the country.
As a result of the ongoing success of the collaboration, Bharathan will continue to work at IRMC through May on a part-time basis.

About Takara Bio USA, Inc.

Takara Bio Inc., a world leader in biotechnology research and development, offers a host of life science research solutions, from enzymes and GMP-grade reagents to contracted cell and gene therapy manufacturing services and is the developer of the RetroNectin reagent, a world standard in gene therapy protocols. Takara Bio is committed to preventing disease and improving the quality of life for all people through the use of biotechnology.