Rockville medtech company OpGen just got FDA approval for its gene testing product

A genetic testing product from Rockville, Maryland’s OpGen is officially FDA certified.

On Monday, the company said its Acuitas AMR Gene Panel was approved by the U.S. Food and Drug Administration (FDA). OpGen, which primarily focuses on early detection and warning signs to antibiotic resistance from hospital patients, is a research company combatting infectious diseases through its molecular testing and technology.

The Gene Panel, which was the flagship product of OpGen prior to its merger with Curetis last April, tracks 28 genetic antimicrobial resistance markers for bacterial colonies from 26 different pathogens (in other words, it helps determine some of the root causes of antibiotic resistance).

The FDA clearance, which in this case allows hospitals and healthcare institutions to use the medical device in treatment, means that OpGen can take its product to the commercial market. According to OpGen CEO Oliver Schacht, the approval is important both for the company and for the ongoing “silent pandemic” of infections resulting from antimicrobial and antibiotic resistance.

“It’s happening slower, but there’s no doubt that if we continue on this path of indiscriminately using broad-spectrum antibiotics, we’re just going to set ourselves up for a situation where more and more bugs are going to get more and more resistant against more and more antibiotics,” Schacht told Technical.ly.

OpGen’s Gene Panel testing device. (Courtesy photo)

According to Schacht, the Gene Panel is primarily focused in the area of infection control and prevention. The genetic testing allows healthcare providers to determine if an infection is caused by a drug-resistant organism that can spread, or if it’s primarily related to someone’s genetics, meaning doctors can reevaluate treatment and therapy plans.

Previous FDA-approved products, Schacht noted, only tested for five markers, compared to Gene Panel’s 28 markers. Although it can’t treat antimicrobial issues, the product can help doctors figure out next steps.

“With anything that’s [antimicrobial resistance]-driven as a doctor, you still have to use your smarts and say, okay, I can rule out certain things because likely they will no longer work,” Schacht said. “Because there are resistance markers that are indicative of a high likelihood of those antibiotics no longer working.”

OpGen actually submitted the product to the FDA all the way back in May of 2019, although it has been working on the product since the company’s IPO in 2015. But Schacht said the process was delayed due to the pandemic, as the regulatory agency was focused on COVID-19-related vaccines and solutions. The Gene Panel solution was previously available as a research-only product, which meant labs had to independently verify the product’s findings, which could take a few days or weeks. With the FDA approval, results can be collected in two and a half hours.

With this approval, Schacht said the company can begin the commercial rollout of the Gene Panel product. Although it has already had two products clear FDA certification in the past, he noted, this approval will boost the company’s credibility which he says will be an asset in its future capital-raising plans. With the commercialization, he plans for OpGen to grow in revenue and begin the shift from a research and development company to a more commercially-driven firm.

Going forward, the company will be looking at additional markets for the product and move into next-generation sequencing and AI-powered algorithms in medtech, which is where he sees the industry going.

“This is a starting point, not an end point for us,” Schacht said. “And as we continue evolving…we want to be one of the leaders in bringing about that change to molecular microbiology in the [antimicrobial resistance] space.”