Three inside one: biobank, CRO, reference lab

That year Mauro was invited to a worldwide Zika conference in Washington, DC. “Keep in mind that a company like mine and people like me normally do not get invited to events like that,” he says, noting that such spots are usually reserved for academicians, researchers, and makers of diagnostic tests. “However, I presented all of the specimens that we were collecting.” At that point, Boca Biolistics had already been in discussion with the FDA as diagnostic companies were clamoring to get Emergency Use Authorization approvals.

He says about a dozen assays became available relatively quickly because of the samples they provided, which allowed for EUAs. “I feel we are indirectly making a contribution to patient testing and clinical evaluations. We’re not making the tests, and we’re not doing the research, but we’re providing important resources for both.”

“It’s an incredible story,” Dr. Kiechle says. “In the year and a half I’ve been here, I’ve already written two abstracts for Zika and one abstract for dengue based on data we’ve collected in the Dominican Republic. And there is still so much more information to pull out. It is like sitting on a gold mine.”

When proposals have been considered and samples gathered, clients can elect to have testing done at Boca Biolistics Reference Laboratory.

“Our newly acquired CAP accreditation is helping this part of the business to grow. It took us a lot of time and effort to get it, and we are very proud of that distinction,” Mauro says. “Diagnostics companies are now saying, ‘You’ve given us the research samples and you are doing clinical trial collection. Now can you also do testing for us as part of the submission package?’ The answer is yes. We can do all manner of comparative testing.”

Clients can specify the platform or platforms on which they want an assay tested—Abbott, Roche, Hologic, DiaSorin, Bio-Rad, Cepheid, Accelerate, and Gold Standard Diagnostics. “We are bringing on new platforms from new manufacturers in 2020,” he says.

“We proceed to test the samples in our lab, generate the data, and provide it to the client along with the rest of the samples we collected. Now they can take that entire package and, if they don’t need anything further, submit it to the FDA,” Mauro says.

Boca can handle submissions to the FDA on behalf of a company, he says. “We do have the capability to do the biostats on the data that come out. We are able to submit to FDA and we have done that process, though infrequently, for some smaller companies. The larger companies have their own regulatory staff and typically do it in-house. But can we do it? Sure. Everything from selling research samples, clinical trials, and then comparative testing. That’s really what makes us different.”

Offering a closer look at the reference laboratory, Mauro says: “We don’t do a lot of clinical testing yet, but now with CAP accreditation we hope to expand in that area. But most of the testing we do is research based or in response to diagnostic companies that need us to do testing on their samples or their assays to make sure they work.”

For comparative testing, sometimes clients’ requests are instrument specific. “For example, a company might say, ‘We need to do testing but we want it done on the GeneXpert.’ Great. We’ve got that,” Mauro says. “Sometimes they’ll say, ‘We just need another competitor that is an approved assay, so tell me what you’ve got.’ If we have it, we have it. If we don’t, we network with another reference lab that does. We’ll work with one of our partner labs and say, ‘We’ve got this study, we’re going to do this component, then we’ll send the samples to you to do the other component.’ The reference labs we’re working with see that as good revenue. It’s diagnostic. They’re not billing insurance, Medicare, or Medicaid. They’re basically getting a check from industry and that’s very attractive.”

Most of the testing currently falls into three categories: tropical diseases (much of which revolves around dengue studies), oncology, and infectious diseases. It is oncology services that Mauro foresees enabling the company’s expansion. “The oncology space is hot—has been for years—but recently it’s through the roof. Our clients are putting a great deal of money into oncology research, liquid biopsy specifically. As a result, we are putting a substantial amount of our resources—revenue and staffing—into oncology. Then we will drill down a little more, mainly looking at doing liquid biopsy.”

He and others at Boca are talking now with companies about three or four contract projects of more than $1 million each. “Initially we are going to help with the collection of solid tumors—biopsies or resections—from all over the world,” Dr. Kiechle says. “We’re also going to collect plasma specimens over a period of six months or five years, depending on the client. In those specimens we’ll be looking for circulating tumor DNA to see how well they predict disease and/or relapse versus using usual cancer biomarkers. So that’s phase one.”

Boca is partnering with a next-generation sequencing laboratory (one Mauro hopes to acquire) so that collected specimens can undergo genomic testing. “That’s the last piece of the puzzle for us—to have a component of our lab that can do NGS testing. This way we can add value to specimens,” Mauro says. “If a researcher is looking for 100 breast cancer tissue sets with specific biomarkers, the whole genome sequencing will already be done. Would that help? Of course. So again, we’re back to the concept of trying to be that one-stop shop.”

Boca is also guiding other labs to mine the value in their own specimens. “More and more frequently, hospital labs and other reference labs are looking to develop or implement a biobank for themselves that would allow an additional stream of income,” Mauro says. “Instead of just testing samples, they could be selling samples that are valuable for research. Right now they are throwing those samples out. We don’t see it as a conflict. Helping a lab to generate extra income or just preserve a resource it already has instead of discarding it definitely pushes research forward.”

Turning the sale of specimens into a new income stream for labs requires minimal work and resources, he says. “We have one lab that employs a licensed tech to pull samples and ship samples to clients. But when the tech is not doing that, he’s working for the lab in other capacities. So it’s a full-time salaried employee who is generating even more money for the lab—a financially viable asset.”

Mauro calls this revenue “bottom-line” money because it is selling samples that otherwise would be discarded. “And just throwing them out, logging biohazards, and so on, adds up to revenue that you have to spend to get rid of the samples. So a lab is saving a little bit. And in today’s health care economy of diminishing reimbursements, every single dollar counts.”

Valerie Neff Newitt is a writer in Audubon, Pa.