Functional Biosciences achieves CLIA Certification of Compliance

Functional Biosciences, a Madison-based biotechnology company, has been awarded its CLIA Certification of Compliance from the Wisconsin Department of Health.

Achieving CLIA compliance was no easy task, according to Kym Larson, laboratory director for Functional Biosciences.

“It’s actually a very long process,” she said. “There’s a long laundry list of requirements to even apply for certification. It’s a long road, not a six-month or a one-year process.”

She says it took the company three years to pull together the necessary parts — outlining processes, putting quality assurance in place, training staff and finding skilled personnel.

CLIA — or Clinical Laboratory Improvement Amendments — regulate labs, requiring them to be certified by the state as well as Center for Medicare and Medicaid Services.

The certification marks a significant change for the company, as it can now do more with the human cell samples it receives. It currently works with research labs, corporations, and government labs that need DNA sequencing services.

“We could work with samples before if it was a research base; what it does now is opens a door to work with human clinical samples for diagnostic reasons,” Larson said. “It opens up a very large door for us, to work with hospitals and patients.”

Functional Biosciences focuses on Sanger sequencing, which allows for the sequencing of small parts of a genome.

The company has been around since 2003, and “has always been relatively small,” according to Michael Flanagan, president of Functional Biosciences. It currently has eight full-time employees.

“CLIA is gonna help us open doors that were closed to us before, so I’m excited about that,” Flanagan said. “Our goal was to accomplish it — we put the effort in and got it done.”

Flanagan added that securing Laurence Berg, a staff pathologist at Gundersen Lutheran, as medical director was crucial to getting the CLIA certification.

“We have a great partnership with our medical director,” Flanagan said.

Moving forward, Larson wants to “grow our business, so we can add more and more services as we go.” She wants to expand partnerships so as to work with national and international clients.

“From there, we would look to expand more services that pertain to DNA sequencing,” Larson says. “For a small company like ours to achieve CLIA is a huge undertaking, that’s the key to all of this.”

–By Alex Moe
WisBusiness.com