How the American Gene Technologies® COVID-19 Lab Could Help Cure HIV

The company is generating significant revenue via PCR rapid testing service

At American Gene Technologies® (AGT), creativity cures in more ways than one. 

In response to the COVID-19 pandemic, AGT™ CEO Jeff Galvin decided to turn “lemons into lemonade” by creating a COVID-19 testing lab. This new testing lab provided security for the in-person staff running experiments in the company’s research lab while also generating more than $10M in funding for its HIV cure program.

At the beginning of the pandemic, accessing COVID-19 PCR testing was excessively difficult. Turnaround times in the central laboratories regularly exceeded seven days, and long lines at specimen collection centers made headline news. Suspected exposure barred employees from completing in-person tasks until their test results came days, or even weeks, later. Since AGT™ was already in human trials with a potential HIV cure, eliminating COVID-19 spread within the company would keep the team healthy and focused on advancing its potential HIV cure, AGT103-T, towards approval and commercialization.

The COVID lab team rose to the challenge. To build the lab, the company turned to two of its younger team members. They were tasked with two directives: build the company a safe CLIA COVID-19 testing lab from the ground up and make connections to local medical organizations to support AGT™ funding efforts. 

The team had to get the lab CLIA certified, which is no small undertaking, before providing testing to its own employees. The CLIA lab certification process is stringent and involved, but AGT™ was able to move through the certification seamlessly and rapidly due to its existing expertise in molecular diagnostic tools and quality control infrastructure. 

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Soon after CLIA certification, the company began testing its 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. Galvin and the lab team realized they had more than enough testing capacity to offer molecular PCR tests to its employees and the public. 

“Major lab companies perform well in the summer when demand for testing is at a seasonal low, however, when demand picks up, their turnaround times begin slipping. Two, three, or even five days of lead time for a test that only takes about four hours to run is simply unacceptable when companies need to stay ahead of a COVID outbreak that can put their employees at risk and cripple operations,” stated Luke Williams, one of the leads on the COVID lab project and a Generalist at the company. 

The AGT™ CLIA-certified lab testing process is modular and scalable to up to 3,000 tests per day. The testing program deploys robotics to automate the process, reduce human inputs, increase processing speed, and virtually eliminate the chance of false results caused by human error. The organization’s testing capabilities are also fully mobile and can be deployed to offsite locations like offices and mass testing sites. A custom cloud-based ordering and reporting system was specifically designed and programmed to efficiently and affordably meet any testing need, anywhere.

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Over the course of a year, the COVID lab team worked together to acquire business partners and learn what these partners needed from the COVID testing lab. This learning period empowered the team to rapidly refine the lab’s practices, which led to the creation of an agile, responsive testing service that met critical business community needs and resulted in a high degree of lab client retention. 

Each new business partner utilizing the lab became a reliable addition to the AGT™ revenue stream, which then flowed into the company’s HIV cure program.

“Our lab has built-in surge capacity. So even when demand skyrockets, we have the capacity to keep our commitment to our business partners. Our reliably fast turnaround times give local businesses a better alternative to the big players in diagnostics, and doctors appreciate that proceeds go to a great cause,” added Williams.

The company’s decision to provide rapid COVID-19 PCR testing helped protect community businesses, the community at large, made a significant contribution to public health in Maryland and also generated more than $10M in non-dilutive funding, all while achieving the company’s mission to reduce human suffering from disease. 

The AGT™ mission lies at the nexus of nature and human nature. Productivity in this space requires bold, inspired decisions—which is how the company started a diagnostics wing that keeps its community safe and its research arm in full swing. 

Looking ahead, the company is excited to begin offering new diagnostic tests, which will  expand the company’s revenue stream to power its phenylketonuria (PKU) and immuno-oncology programs. 

If you need a COVID-19 PCR test, want your results quickly, and would like to support AGT™ in its goal to cure HIV and monogenic disorders, visit www.myresultnow.com and find a partner clinic near you.