Diagnosis On-demand: Houston Methodist Develops V-chip Medtech Device

Methodist Hospital Houston wants to make disease diagnosis as simple as a pregnancy test.

That’s the idea behind the “V-chip,” a credit card-sized medical device being developed at the hospital that is designed to allow doctors and other caregivers to immediately diagnose as many as 50 diseases with just a drop of blood or urine.

“This is the frontier” of chemistry and diagnostics, says Lidong Qin, the chip’s inventor and a principal investigator at Methodist. “V-Chip is accurate, cheap, and portable, and can do 50 different tests in one go.”

V-chip, which is short for “volumetric bar-chart chip,” is composed of two thin pieces of glass that slide together. One plate has a series of grooves cut into it. The other has wells that contain up to 50 different antibodies to specific proteins, DNA or RNA fragments, or lipids of interest, along with hydrogen peroxide, the enzyme catalase, and a dye. When a blood or urine sample is added to the plate with the grooves, the virus or other pathogen in the sample binds to the antibody for that particular disease in one of the grooves. That, in turn, activates the catalase enzyme, which splits the hydrogen peroxide into water and oxygen. The oxygen then pushes the dye up the grooved channel. The greater the amount of the substance of interest, the farther the dye is pushed in that channel. The results can be read like a bar chart with different levels of dye for each groove.

In essence, the chip is a small, convenient version of a standard assay called ELISA (for enzyme-linked immunosorbent assay).

It’s still early days for the V-chip. To further the chip’s development, Methodist, in the last two months, signed two research sponsorship agreements with a private medical device company and a health IT startup interested in commercializing the device. And, before it could get into the hands of medical professionals, the device would still need to jump regulatory hurdles, including clinical trials, for eventual approval by the FDA.

Qin says the device can detect infectious diseases, such as cholera, following a natural disaster when power and sanitation systems are shut down or insulin levels for soldiers on the battlefield. It also could be used to do routine checks for important parameters like cholesterol levels in patients in villages without access to modern healthcare facilities.

The chip’s uses even extend beyond medical diagnosis. “This could be used for water purification, if you find an appropriate marker,” says Joanne Mitchell, director of Methodist’s tech transfer office. “This is a broad platform.”

Typically, such tests are done in a laboratory environment using large, complex equipment such as mass spectrometers. Or caregivers reach a diagnosis through fluoroscopy analysis, which must also be done in a lab.

The potential market is huge. Point-of-care diagnostics is expected to grow to $16.5 billion in 2016, according to BCC Research in Wellesley, MA. Such diagnostics can include glucose monitoring—the largest segment—blood chemistry analysis, and diagnosing infectious diseases or tumors. Eliminating even a few days of waiting for a laboratory—when one is available—to come back with results is significant, especially one when treating patients with fast-moving diseases like cholera.

The development of a diagnostic laboratory-on-a-chip has long been a goal of medical researchers. Because of the importance of rapid diagnoses for the military and in areas without lab facilities, for instance, the Defense Advanced Research Projects Agency, or DARPA, and the National Institutes of Health have been funding a number of research teams. For instance, grant funding has helped GE Global Research, the technology development arm of General Electric (NYSE: GE), and University of Washington scientists to develop a diagnostic device, the size of a pack of playing cards, to detect infectious disease with a nasal swab.

In a similar project, Singapore’s Agency for Science, Technology and Research (A*STAR) and Veredus Laboratories launched a biochip that can spot dengue fever, malaria and 13 other diseases from blood or serum samples.

Mitchell claims, however, that none of the other point-of-care diagnostic devices on the market provide the ease of use or are as efficienct as the V-chip.

Qin at Methodist first came up with the V-chip’s design nearly four years ago and has since acquired patents on the technology and tested it using blood samples from hospital patients.

Last year, the NIH gave Methodist $2.1 million in grants to help further develop the V-chip for such uses as indicating the presence of drugs in urine and measuring blood biomarkers associated with liver cancer. Methodist says those projects are ongoing.

Ramesh Kesanupalli, founder and CEO of Sparsa, a health IT startup that is launching in August, is helping Methodist with commercialization plans of the device. “The V-chip is going to be a very critical part of what we want to do,” he says.

Kesanupalli sees the V-chip as a health management tool. Adult children could use it to make sure elderly parents are properly taking their medications, he says. Or women and their doctors could search for breast cancer biomarkers at quicker intervals than the two-year cycles that most insurers will authorize mammograms. The data, he says, would be easily uploaded and shared in Sparsa’s Web platform, which is designed to be a centralized portal of health data.

“We’re taking the prototype and talking to manufacturing partners about how to convert it to something where we can do large-scale manufacturing,” Kesanupalli says.

Kesanupalli is a longtime Silicon Valley entrepreneur—one of his companies, Network24, was bought by Akamai for $200 million in 2000—who created Sparsa after watching the inefficiency in his wife’s cancer treatment. He had moved her from a hospital in San Jose to one in Los Angeles, but she couldn’t begin treatment for three days because health records had not been transferred.

The second company Methodist is partnering with is Biomet, an Illinois company that manufactures orthopedic devices and biologics products. Adam Finley, the company’s project manager in product innovation, says the Chicago-area company is testing the chip for diagnostic abilities related to earlier detection of biomarkers in patients that might point to their needing one of the company’s prostethic devices or biologic treatments.

“It’s our goal to look at the diagnostic world to see what could help our products,” he says. “We look to foster a relationship that way. The V-chip is pretty cutting edge and cold make a great pairing with our products.”

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