University of Arizona scientists are working on ways to make the needle biopsy — a common way to test for cancer — a much more effective diagnostic tool.
Researchers at the UA and Banner-University Medical Center Tucson have developed a new kind of biopsy needle that can gather seven times more tissue with essentially the same minimally invasive procedure, as well as cauterize biopsy wounds to head off complications.
The UA has filed to patent the device and licensed it to a company formed by its faculty inventors, Dr. Michael C. Larson, a resident physician in the Department of Medical Imaging at the Banner-University Medical Center Tucson, and Dr. Charles Hennemeyer, assistant professor of medical imaging and division chief of vascular and interventional radiology at the UA College of Medicine.
The business side of the startup company, Data Driven Diagnostics Sciences Inc., or D3 Sciences, is led by CEO Nicholas Lim, who also is a volunteer in Tech Launch Arizona’s Commercialization Partners program.
Needle biopsies allow physicians to take a sample of a tumor or other tissue of concern as a less-invasive alternative to a surgical biopsy.
But they often take too little tissue to develop a comprehensive diagnosis, prompting doctors to prescribe broad-spectrum chemotherapy drugs that can have serious side effects, the UA researchers say.
“Even if we stab eight to 10 times, to try to get enough tissue, it’s just a miniscule amount of tissue that gets to the lab that ultimately will determine what type of chemotherapy, or radiation or surgery is appropriate,” said Larson, who started his residency at Banner in 2016.
The larger tissue samples will allow oncologists to prescribe targeted genetic and molecular tests as part of a growing trend toward “personalized” medicine, the researchers say.
Larson said he and his colleagues have found past efforts to develop a larger-volume biopsy needle system, but more recent research has been focused on getting more results from small samples.
“In our patent search, we came across a few somewhat similar things, about people trying to get more tissue, but it seems like more and more people have just been trying to push the limits and do more with less,” he said.
In contrast, D3 Sciences’ initial marketing slogan is, “Do more with more.”
Unlike traditional biopsy needles, which extract a tiny core of tissue, D3 Sciences’ needle rotates to take more tissue, while applying vacuum pressure from the back end.
“It actually cuts and spins so instead of just a cylinder of tissue, we get a coil or a spiral — a Slinky, essentially, Larson said.
Once a sufficient sample is taken, the needle cauterizes, or burns, the edges of the wound as it is withdrawn, to prevent bleeding or other complications.
The prototype of the new instrument, initially named Triopsy Edge, features a cutting blade and cauterizes the tissue with a probe heated with electrical current.
It could take years and millions of dollars to take the new biopsy needle through clinical trials to the patients’ bedside.
But Larson says he and other company officials believe its current needle could qualify for fast-track approval by the U.S. Food and Drug Administration under 510(k) clearance for medical devices that are substantially similar to approved devices in safety and effectiveness.
In the future, the device could employ radio-frequency (RF) technology, which can cut through and cauterize tissue more precisely, Larson said.
But because RF surgery technologies are widely patented, D3 Sciences will look to partner with another company to incorporate RF tech into a future version of its biopsy needle, he said, adding that such a new design may not qualify for fast-track FDA approval.
D3 Sciences was formed after Hennemeyer and Larson brought their idea to Tech Launch Arizona’s National Science Foundation Innovation Corps program, where they were paired with Lim as their mentor.
Through participating universities, the NSF’s I-Corps program prepares scientists and engineers to extend their focus beyond the laboratory to help drive NSF-funded, basic-research projects to market.
Lim says the company’s overarching goal is to accelerate diagnosis and therapy, noting that repeat biopsies are frequent and have been shown to increase the cost of care by more than 24 percent.
Doug Hockstad, assistant vice president of Tech Launch Arizona, said that as cancer therapies evolve toward more personalized and individualized approaches, diagnostic and prognostic testing will develop with increasing speed.
“This next generation biopsy instrument has the promise to deliver the tissue samples needed to perform these leading-edge tests,” Hockstad said.
