Startups
Tech + Health Month 2021

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

The OpGen Gene Panel product tests for causes of antimicrobial and antibiotic resistance in hospital patients. The FDA approval, CEO Oliver Schacht said, will help it move away from research and development and into a commercial company phase.

OpGen CEO Oliver Schacht. (Courtesy photo)
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.”

Companies: OpGen Inc.

Before you go...

Please consider supporting Technical.ly to keep our independent journalism strong. Unlike most business-focused media outlets, we don’t have a paywall. Instead, we count on your personal and organizational support.

3 ways to support our work:
  • Contribute to the Journalism Fund. Charitable giving ensures our information remains free and accessible for residents to discover workforce programs and entrepreneurship pathways. This includes philanthropic grants and individual tax-deductible donations from readers like you.
  • Use our Preferred Partners. Our directory of vetted providers offers high-quality recommendations for services our readers need, and each referral supports our journalism.
  • Use our services. If you need entrepreneurs and tech leaders to buy your services, are seeking technologists to hire or want more professionals to know about your ecosystem, Technical.ly has the biggest and most engaged audience in the mid-Atlantic. We help companies tell their stories and answer big questions to meet and serve our community.
The journalism fund Preferred partners Our services
Engagement

Join our growing Slack community

Join 5,000 tech professionals and entrepreneurs in our community Slack today!

Trending

An overlooked part of entrepreneurial ecosystems? The lawyers

DMV labor force, by the numbers: 7x the legal jobs — and salaries to match

15 virtual and in-person tech community events for September

This Week in Jobs: Build a new career with these 24 open roles

Technically Media