Same-Day RT-PCR COVID-19 Testing

AGT’s Same-Day RT-PCR COVID-19 Testing Program is Helping People Safely Return to the Workplace

Jeff Galvin, the CEO of American Gene Technologies, has always made investing in his team and the BioHealth Capital Region (BHCR) a top priority. 

In the latest sign of the company’s commitment to its employees and the region, AGT recently announced the creation of a Clinical Laboratory Improvement Amendments (CLIA)-certified lab that is actively providing RT-PCR testing for COVID-19. 

AGT’s new COVID-19 testing capability provides less expensive, more convenient, and highly accurate same-day COVID-19 to its own staff and the general public. RT-PCR testing is the “Gold Standard” of COVID-19 tests; AGT’s testing program was designed to help its employees and other local organizations’ staff return to and remain safe in the workplace.

“It’s my personal belief that the key to any successful business is the people. It’s always been AGT’s philosophy to invest heavily in our team members to make sure we can maximize their ability to be productive. We have a high standard for people that we allow to join our company, but then we also provide an environment where they can not only meet our standards but also surprise us,” stated Galvin.

“We’ve always invested in great facilities, and our CLIA lab is part of our commitment to our team and the surrounding community. Human beings react to environments, and we want to create the very best atmosphere to inspire innovation,” he added. “People are what it’s all about. I listen to our team. People need to feel heard and to be continually challenged so they can jump in with both feet. A big part of that is knowing you’re safe at work.”

When COVID-19 emerged, AGT, like many other area businesses, had to move most of its team into a virtual work environment. That is, everyone but essential staff that had needed to remain in the lab to keep AGT’s leading-edge cell and gene therapy pipeline moving forward. 

AGT created stringent safety protocols to keep its lab team safe to protect its essential lab staff. However, one employee reported possible COVID-19 exposure and was subsequently sent home.

“We said okay, go get a RT-PCR test, and if you’re negative, you can come back to the office. Well, they got the test fairly easily, but it took 14 days to get the result. So we paid that employee for two weeks because it was the right thing to do to reduce their stress levels. The problem became obvious quickly: if we suspected any COVID exposure, we’d lose our team member for an extended period of time, so we decided that bringing testing in-house was the right move for our team and our business. Who better to create a COVID-19 testing lab than a company that really understands the technology and the process?” stated Galvin.

Galvin had already been speaking with Marc Elrich, Montgomery County, Maryland’s County Executive, about solving the region’s COVID-19 testing challenges. Both Galvin and Elrich agreed that if any region could solve these COVID-19 testing issues, it was the BHCR with its rich network of biopharma companies, government agencies, and large research universities. 

Galvin and AGT rose to the challenge, and after receiving CLIA certification, began testing their employees. AGT found that their test could get highly accurate COVID-19 test results in as little as four hours. Eventually, the company scaled up its testing capacity to 1,000 tests per day. With only 40 employees, Galvin and his team realized they had more than enough testing capacity to offer molecular PCR tests to AGT employees and the public. 

The CLIA-certified lab testing process is modular and scalable to up to 3,000 tests per day or more. The testing program deploys robotics to automate the process, reduce human inputs, increase the processing speed, and virtually eliminate the chance of false results caused by human error. AGT’s testing capabilities are also fully mobile and can be deployed to offsite locations like offices and mass testing sites.

The testing program was specifically designed to efficiently and affordably meet any testing need, anywhere. 

Existing 15-minute rapid COVID-19 testing has a 15% false-negative rate. To be fully confident in a negative result, an individual would need to get the 15-minute rapid test twice, which would cost approximately $240. AGT’s RT-PCR test is far more sensitive and accurate as AGT’s testing approach isolates and amplifies the RNA before running the PCR. AGT’s test costs less than a 15-minute rapid test and provides highly accurate results with just one test. AGT’s RT-PCR program offers a convenient, accurate, and affordable testing option with much faster results than competing PCR testing options.

The CLIA-lab certification process is stringent and involved. AGT moved through the certification seamlessly and rapidly due to its existing expertise in molecular diagnostic tools and quality control infrastructure. 

Once the CLIA-lab and testing capabilities were up and running at AGT, the company began reaching out to the community, contacting doctors and testing service providers that needed same-day test results at a lower cost. To facilitate general public testing, the company created an online system for appointments and other test facilitation needs. AGT stood up this testing capability in about a month; the CLIA-certified lab was up-and-running by mid-January 2021. AGT has continued to build out its network of partner clinics. 

Luke Williams, Marketing Specialist, has led AGT’s COVID-19 testing community outreach efforts.  

“There’s a shortage of fast, affordable diagnostic testing right now. If clinics and community health organizations are willing to jump in, we can make same-day RT-PCR testing the standard for COVID-19 testing in the DC metropolitan area” stated Williams.

“We look for partnerships wherever we can make a difference. For example, one of our clients works with diplomats in Washington D.C. that are not covered by the CARES Act or insurance and need fast access to RT-PCR test results for international travel. “Rapid” tests just don’t cut it. There are also quite a few clinics in the Washington D.C. metro area that work closely with the HIV community; offering our tests to their patrons would carry an added benefit, since all the proceeds from our testing program will go toward supporting our clinical-stage HIV Cure Program,” stated Williams.

All of the proceeds from AGT’s COVID-19 testing program will help fund the company’s lead therapeutic candidate, AGT103-T, a single-dose, autologous cell therapy intended to cure HIV. The program is currently in Phase I human trials.

“In an environment where diagnostic testing is dominated by large, for-profit entities that return results in 2-5 days, we’re offering the top-shelf RT-PCR test with same-day results for a lower price while supporting a good cause. We have drastically improved upon the standard for COVID testing, so the sky’s the limit as far as who can benefit from our testing program,” Williams added.

“Providers should really think about who they are choosing to do their testing. Choosing AGT for their testing is similar to donating to finding cures for serious diseases. Community means a lot to us at AGT, and our testing program reflects this. It’s really a win-win-win,” shared Sasha Whitaker, Digital Marketing & Communications, at AGT. 

“If we can get this line full, we’ll be helping one thousand people a day,” shared Galvin. “I want people not to be worried about coming into the office. Social contact is really important. People are getting overwhelmed at home and are stressed out. We want to enable them to come back to a great work environment to do what they love, no matter where they work.” 

The AGT environmental monitoring approach is ideal for organizations looking to safely bring employees back to the workplace while reducing the potential for spreading the novel coronavirus inside of the office.

“Our mission is to cure cancer and HIV and to prevent deaths from diseases. Our team will work on any idea, including COVID-19 testing, to create a better future for society,” he added. “We have the best RT-PCR testing that’s available. There’s a lot of noise out there around COVID-19 testing, but our employees are regularly tested three times a week and are walking around the office feeling confident they aren’t spreading COVID. They can go home on the weekends to their families feeling good about that too,” stated Galvin.

“We think our COVID-19 test can make a great contribution to this area. We can scale up to any testing need. This is what can happen when you gather really smart, disciplined, passionate people at an organization—you can really change the world,” shared Galvin. 

Companies Already Using the RT-PCR testing program

To learn more about AGT’s affordable, same-day RT-PCR testing program, please contact:
Luke Williams at [email protected]