NEW YORK (360Dx) – Boca Biolistics, a contract research organization specializing in in-vitro diagnostics, has a new business — as a reference laboratory for high-complexity testing.
Through the new reference lab — created by converting a portion of its existing lab — the company aims to leverage its vast inventory of high-complexity laboratory testing equipment and its team of experienced lab personnel to serve a new client base: hospitals.
"For hospitals, we are going to be a reference lab, but a reference lab for newer emerging technology that hospitals don't have access to themselves at this point," said Joseph Mauro, president and CEO of Boca Biolistics and Boca Biolistics Reference Laboratory.
The new Boca Biolistics Reference Lab will offer hospitals US Food and Drug Administration-cleared testing that Boca Biolistics has supported through its CRO services, as well as testing on equipment from other manufacturers that the company uses for its comparative testing services.
Pompano Beach, Florida-based Boca Biolistics has provided CRO services to test developers such as Vela Diagnostics and Accelerate Diagnostics. For Vela Diagnostics, Boca Biolistics supported development of real-time or quantitative polymerase chain reaction testing, as well as next-generation sequencing. Though its work with Accelerate Diagnostics, Boca Biolistics has supported the development of the company's Pheno system for antibiotic susceptibility testing and antimicrobial management for sepsis patients, according to Mauro.
The company's contract research organization services include providing samples from its biobank for early-stage testing; clinical trial management services from initial study design to final regulatory submission; and comparative testing, through which clients can compare tests they are developing to similar tests already on the market.
"We have a very wide breadth of tests that we offer between all the different platforms we have, probably a few hundred tests, maybe more," Mauro said. "The ones that we are most focused on are the NGS and the qPCR testing from Vela, and the AST from Accelerate, because those are newer types of testing, and we feel lucky that we are able to offer these tests as an early adopter," he said.
Boca Biolistics began building the new reference lab about a year ago. The reference lab is currently CLIA certified, and is in the process of seeking College of American Pathology accreditation, according to Mauro. The expansion involved adding six new full-time staff members. Frederick Keichle, a pathologist who formerly served as a consultant for the company, is the reference lab's medical director, and Ron Carlton is the lab's medical science liaison. The other hires include a technologist to manage lab software, and clinical lab personnel to perform testing.
The reference lab is equipped with the entire Vela Diagnostics suite of tests and Accelerate's AST testing, as well as testing technologies from Hologic, DiaSorin, Abbott, Roche and BioFire, which the company also uses for comparative testing, Mauro said.
Boca Biolistics built the reference lab inside its existing lab in its Pompano Beach, where the company had a surplus of space. The lab is approximately 10,000 square feet, Mauro said.
Boca Biolistics already works with hospitals on clinical trials conducted on behalf of CRO clients, Mauro said. The company aims to form tighter relationships with hospitals through a combination of clinical lab partnerships and reference lab services, and is currently in discussions with several nearby Florida hospitals about using the service. Once the first hospital begins using the service, the company expects further expansion of its lab staff, which currently is made up of approximately 20 full-time lab staff, in addition to front office personnel, Mauro said. The company is focusing on nearby hospitals because some of the advanced testing the company offers, such as the Accelerate's AST testing, is STAT testing, which requires short turnaround times, he said.
By offering new types of testing to hospitals, Boca Biolistics aims to enable hospitals to use advance testing methods before they are ready to decide whether to make the investment to bring equipment into their own hospital labs, Mauro said.
"As a service, we can afford hospitals the opportunity not to have to have people in house who know everything about the test," he said. "We already know these tests because we are helping to develop the diagnostics."
Once hospitals are ready to bring testing instruments in house, Boca Biolistics can help them transition to setting up and managing the new in-house testing platform, he said.
Ideally, as hospitals do that, Boca Biolistics will have newer tests that it can offer to hospitals through reference lab services, Mauro said.
"There is always going to be the next new test that we can offer to hospitals first," he said.