“We should have had enough, but we couldn’t get sufficient cells to complete the testing,” he recalls. Knowing cells must have been lost somewhere, he retraced the steps of processing the cell sample.
What he found gave him an idea that would become Cell Disk, a revolutionary way to collect cell samples.
Cell Disk is a simple yet innovative design that allows researchers to access the bottom of a centrifuge vial directly in order to avoid losing valuable cells in a sample. The technology comprises a centrifuge vial with a screw-off bottom. The elegant design of the Cell Disk enables medical professionals to use the same vial for both the biopsy and laboratory testing, simplifying the testing process and reducing chances for error.
To understand why that simple feature could make an important impact on precision medicine requires a basic understanding of advancements in diagnosing and treating cancers.
The Problem: Losing Cells in the Process
Not long ago, all cancers were thought to be largely the same, and biopsies served the relatively simple purpose of confirming a malignancy.
Today, clinicians have a far better understanding of the different types of cancers and how they can be treated. Knowing the type of cancer a patient has, along with his or her genetic makeup, has the potential to lead to very effective treatments.
This personalized precision approach to medicine necessitates significant genetic and pathological testing that exposes cancer cells to multiple potential treatments to determine which could prove most effective.
“We study the tumors to get a diagnosis on a microscopic level,” says Tian. “And we need material to do the genetic testing.”
A lot of material, microscopically speaking. Reaching a precise diagnosis by observing the tumor cells’ reaction to different treatments requires that multiple samples be available for the tests.
For some tumors, getting a core sample is a routine procedure. But for others, especially central lung and pancreatic lesions, the only way to collect material is through a process called fine needle aspiration biopsy.
As the name indicates, the process involves using an extremely fine needle and syringe, inserted directly into the tumor to draw out cells. The process can be painful to the patient and carries a slight risk of complications, which are magnified in patients suffering from advanced, aggressive cancers. But fine needle aspiration is the only option.
Once cell material is collected, it’s processed in a laboratory to prepare it for testing. One of the key steps in this process is running the material through a centrifuge to create what researchers call a cell pellet, which they make into a cell block to conduct the tests.
Tian, who performed molecular testing as a pathology resident at Wake Forest Baptist Medical Center, knows how important cell blocks are to finding the best treatment for a tumor.
“The cell block makes it possible to perform the modern molecular testing needed to find the most effective treatment for each patient,” said Tian, who is now associate director of pathology at Janssen, a pharmaceutical company.
Given the nature of fine needle aspiration biopsy and the effects of repeated procedures on very sick patients, Tian was continually frustrated when cell blocks did not contain enough material for the testing. It was a well-known problem in pathology circles, but most accepted it as a fact of life.
“But I thought that there had to be a better way,” Tian recalls.
His conviction led him to retrace his steps, looking for the lost cells. He found them—literally—at the bottom of the centrifuge vials.
Technicians typically extract cell pellets using one of two methods: either digging them out with a tool or using fluids to float them to the top. Both methods hold the potential for error and—despite technicians’ best efforts—much of the cell material was being left in the vial, inaccessible and wasted.
The Solution: Rethinking an Old Product
The solution seems so simple.
If the centrifuge vial makes extracting fully intact cell blocks too difficult, why not rethink the vial itself? Instead of digging them out or floating them to the top, why not just unscrew the bottom of the vial?
With this idea, Tian invented what came to be called the Cell Disk, taking it to the Center for Technology Innovation & Commercialization at Wake Forest Innovations for development. The simple design consists of a conical vial with a small cavity at the bottom where the cells aggregate to form the cell pellet. To collect the cell pellet, a technician needs only to unscrew the bottom.
“It was a ‘Why didn’t anyone think of this before?’ kind of moment,” says John Druga, licensing director at the Center, who is partnering with Tian and others to prototype, test and refine Cell Disk to demonstrate its value in an actual laboratory setting.
The reason no one thought of the Cell Disk before is simple: there was no need—until now.
Druga explains, “Genetic testing was not a prevalent form of cancer testing until recently, so breaking the cell pellet and leaving material behind was no big deal.”
But the emergence of medical cytology and genetic testing of cancer cells has caused the centrifuge vial—essentially unimproved for more than a century—to finally show its age.
Cell Disk has the potential to be an important tool in the increasingly complex fight against cancer. By streamlining the process of creating cell blocks and keeping them intact, it gives researchers the material they need to conduct extensive genetic testing on an individual level.
“Cell Disk makes it that much easier to find the right drug for the patient,” Druga says.
Most importantly, the invention helps provide enough material so doctors don’t have to go perform multiple fine needle aspirations on patients.
“We don’t want to keep going back to sick patients and poke them with needles to perform more tests,” says Druga. “While Cell Disk is a simple, almost low-tech invention and a long-overdue improvement to a standard, nondescript laboratory tool, its most important influence will be felt well beyond the lab as it makes the process of diagnosing and treating cancers faster and more efficient, giving patients a better shot at getting better.”
Download a non-confidential summary about Cell Disk or learn about other novel medical devices in development through Wake Forest Innovations by visiting our technology portfolio or contact Wake Forest Innovations by emailing innovations@wakehealth.edu or calling +1.336.713.1111.
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