Science news from the Bond LSC



Patented photoacoustic invention capable of fast, inexpensive, early detection of melanoma

January 3, 2012 | Denise Henderson Vaughn

Research at MU has yielded a new tool to aid the fight against metastatic melanoma and that tool is now poised for commercial development. Bond Life Sciences Center investigator John Viator has invented a device that can detect single melanoma cells in a blood sample at a fraction of the cost of current cancer tests. He recently signed royalty and licensing agreements with the university, clearing the way for his newly formed company, Viator Technologies Inc, to take advantage of this intellectual property and go into production.

Melanoma, an aggressive cancer, is characterized by skin growths that of themselves aren’t seriously dangerous, but it can become a quick killer if cancer cells detach and enter the bloodstream, then lodge and grow elsewhere in the body. When melanoma cells metastasize in this manner, patients often live less than a year, and fewer than 20 percent live five years.

Viator

“It’s extremely important to catch metastatic melanoma at an early stage,” said Viator, an associate professor in MU’s Biological Engineering Department.

But finding metastatic melanoma as it spreads through the body has not been overly successful in the past. Detection with MRI or CT imaging equipment requires tumors that are at least a few millimeters in diameter (similar to a grain of rice), at which size they already consist of millions of cells.

With Viator’s test, “we’re looking in the blood system for single (melanoma) cells that are propagating through the body,” he said. “This is much more effective because you’re looking for a cancer sooner than you could ever detect it with an imaging test,” he said. “That’s good for the patient and its good for the clinician, because if you can find cancer when it’s just at the cellular level, then you’re fighting a small number of cells versus trying to fight a tumor the size of a softball that’s growing around your kidney.”

Viator has developed a prototype device, which, when refined into a commercial product, should be about the size of a small copy machine. “You would take blood samples and put them in, and 10 minutes later you would have either a readout or some indication of the state of that blood sample, whether it has cancer in it or not,” he said.

Compared to current testing technology, this new machine will have “lots of advantages,” said Viator. “It’s (relatively) inexpensive, fast, compact, easy to use, and offers earlier detection. It has the potential to really change a lot of the things in the management of cancer.”

Laser and ultrasound technologies merge to create photoacoustic testing

The scientific underpinning for this invention involves photoacoustics, or laser induced ultrasound. Viator uses this tool in conjunction with the properties of density, light, heat, and color to cause cancer cells to react in a manner that makes them detectable and different from surrounding cells.

A first step in the testing process is to use a centrifuge to separate a patient’s blood into white blood cells and red blood cells. Melanoma cells are about the same density as white blood cells, but less dense than red blood cells, so melanoma cells are naturally thrown in with white blood cells as the blood separates.

The resulting batch of white blood cells (plus any cancer cells present) is then pumped through narrow tubing that contains a tiny glass box, where the cells are hit with a short pulse of high-intensity laser light as they pass by. Since white objects reflect light, the white blood cells are not affected, but any cell with pigment will absorb the light. The intense laser beam heats such a cell rapidly, causing thermo-elastic expansion, which in turn causes the expanding cell to emit a measurable pressure wave. Detection equipment senses this photoacoustic wave and thus locates the cancer cell.

Using this method, a pigmented melanoma cell stands out “like a big black 18-wheeler running down the freeway among thousands and thousands of white Priuses,” Viator said. Pigmented melanoma cells can be separated from the healthy white blood cells and then individually tested using biomolecular assays or imaging.

“Not all melanoma cells are the same. You can do some molecular tests and find out (things such as) do they have this genetic type? Or do they have these cell surface markers? We know that such-and-such a cell responds really well to this type of drug, so you could personalize your cancer therapy, potentially, by capturing the cells you’ve detected in the blood sample, and understanding the disease better,” Viator said.

Viator
John Viator

New drugs and new device together might revolutionize treatment

Currently, treatment tools for melanoma include surgery and a drug, interferon, which is only about 20 percent effective, said Viator. But two new melanoma drugs have been approved this year, and a dozen more are in phase three trials.

“So the availability of melanoma therapies is going to explode,” Viator said. “The more therapies there are, the more valuable this (photoacoustic technology) will be, because it can track response to disease. Are tumor cells increasing or decreasing over time? Is the medicine working? So you could try one treatment and if the blood tests are showing that you’re getting sicker because you have more of these cells, then you switch over to the other drug. So you’re not just fighting blindly. You’re using targeted therapies and using this tool to make sure that what you’re doing is effective.”

Initially, Viator’s device will only detect and monitor metastatic melanoma. But his lab is continuing research, with the goal of using photoacoustic methods to detect other cancers such as breast cancer and prostate cancer.

Low cost machine makes “a convincing case”

In offering the machine for sale at a clinic or hospital, Viator expects to persuade “the business people” by arguing “we can find it (melanoma) sooner, and we can find it cheaper.” With an initial outlay somewhere around $100,000, the machine should compete aggressively with MRI equipment, at over $1 million. Viator thinks clinic accountants will see the logic in “rather than patients doing an MRI twice a year, at $4000 a pop, why don’t you do this four times a year, at $200 a pop?” he said.

“The accounting people are going to look at it and say, if we do so many of these tests per year, not only is it better for the patient, but we actually make our money back. So I think it’s a convincing business case as well as a very convincing clinical case. Everybody wins.”

Due to the machine’s comparatively low cost, “I think we can make this type of early cancer diagnosis much more accessible,” Viator said, because it could be available in places where medical facilities can’t justify purchasing a much higher-priced MRI machine.

Required FDA testing is slowing commercial availability

Unfortunately for cancer patients, they will have to wait a few years to be tested with this new device, because it must pass FDA tests for safety and effectiveness before it can be sold to clinics. “Safety is not a big deal,” said Viator, because patients only have to provide a blood sample. “But with efficacy, we have to prove that we’re doing what we say we’re doing,” which involves testing cancer patients’ blood and correlating the results with their disease status.

Viator is confident that these required tests will demonstrate his device is highly reliable. The machine can grab and save any suspect cell, therefore these cells can be examined microscopically or genetically to confirm their identity.

FDA testing is expected to reveal the percentage of “false positive” test results. Based on current lab results, Viator hopes and believes that false positive results will be insignificant. If so, then the machine could be used preventatively, “like a cholesterol test,” to screen for melanoma cells during a patient’s annual physical.

Researchers can begin using invention soon

The FDA does not require completion of these tests before the machine can be used for research purposes, which means scientists in academia or industry could use the device for cancer studies as soon as it is produced. Thus, companies testing new cancer drugs would be able to use the machine to assess their drugs’ effectiveness.

According to Viator’s timeline, the desktop device should be available to researchers by the end of next year, and then after two or three years it may be commercially available for clinical use, he said.

New corporation will commercialize intellectual property

Viator Technologies Inc. formed in March; that company now has exclusive license to commercialize the intellectual property involved with the device and its patent. The university owns the patent; the institution will be paid royalties on any future sales. Because he is the inventor who generated the intellectual property, Viator, as an individual, will also receive a percentage of patent royalties.

“So if the company is successful in selling this thing, a percentage of sales comes back to the university,” Viator said.

At this time, only the prototype has been built; no product has been produced for sale, and no orders have been received. And the product name? “We’re still kicking that around,” he said.

“There are still a lot of unknowns. The whole thing about commercialization has to do with risk, convincing other people to take risks, minimizing risks, so there’s still a long way to go,” Viator conceded.

On the flip side of the risks and the unknowns, the bottom line is that this machine could offer the win-win scenario of detecting cancer very early for a comparatively low cost. Viator is betting his career and his future on it.

“I think it could do a lot of good. I really do,” he said.