New Rapid Diagnosis Tool for Cardiovascular Disease - National Research Council Canada

Dr. Anthony Shaw wants to shine infrared light through your blood. And it could save your life. He's the lead scientist on a ground-breaking NRC project to use infrared spectroscopy for the rapid analysis of the tell-tale blood chemicals pointing to cardiovascular disease.

"We're making a clinical device and we're going to show that it works," says Dr. Shaw, a research scientist with the NRC Institute for Biodiagnostics (NRC-IBD) in Winnipeg. "We think it can revolutionize clinical diagnosis."

Light ID

Spectroscopy is the science of measuring the emission and absorption of different wavelengths (spectra) of visible and non-visible light. Spectroscopy has traditionally been used in the physical sciences to probe the composition (what is there and how much?) of materials ranging from medicinal ingredients to the stars in the sky. More recently, spectroscopy has been adapted for use in a wide range of biological research areas, such as biochemistry and toxicology, addressing the same fundamental questions for ever‑more complex samples.

Infrared spectroscopy (IR spectroscopy) uses the infrared portion of the electromagnetic spectrum to investigate the composition of a sample. By passing infrared radiation through the sample, and seeing which wavelengths are selectively absorbed by the sample, we build up a "spectrum" of absorptions that serves as a unique chemical fingerprint of the sample.

Scientists at NRC-IBD are using the mid-IR spectroscopic fingerprint of various biological fluids as the basis to perform many common clinical tests, including cardiovascular risk panels, blood tests, and urine tests, opening the door to routine diagnostic testing without the need for any chemical reagents.

Dr. Shaw's team recently received an honourable mention as part of the NRC Business Case Challenge 2005 (see the NRC Highlights for another story describing the competition).

In the past decade, infrared (IR) spectroscopy [see sidebar] has dramatically changed how substances are analyzed in chemistry labs. And the technique is now already widely used in the agricultural industry. Today IR spectroscopy is used to assess the quality, for example fat and protein levels, of foodstuffs from milk to wheat.

However, this proven technique has yet to break into the lucrative and highly competitive clinical diagnosis market. Anyone who has been to the lab for a blood test has used the services of this market.

Dr. Shaw plans on offering an alternative. His team's first gambit into this market is a proprietary technique for using IR spectroscopy to measure the lipid panel. This is the hit list of blood fats that physicians use to assess your risk of heart disease. The lipid panel includes low and high-density cholesterol, triglycerides and total cholesterol.

"What we do is simply measure the spectrum of a single drop of blood serum, and quantify each component based on its unique molecular fingerprint," says Dr. Shaw.

The enormous advantage of this approach is that it doesn't use chemical reagents, which are used to detect and/or measure substances and chemicals found in solutions, such as blood. For example, to get a lipid test a physician sends a blood sample to a lab for analysis. There the sample is mixed with various chemical reagents, one for each desired test, to produce the results.

However, with the IR spectroscopic technique the testing can be done at the point of care and produce a result in less time than it takes a patient to skim a magazine article in the waiting room. Dr. Shaw says that each IR spectroscopic test will be cheaper and faster than current methods, and with no chemical waste.

"If the physician gets the results immediately it means that the patient gets feedback then and there. This not only improves treatment, since the appropriate care is prescribed immediately, but also saves the patient returning several weeks later to get the results," notes Dr. Shaw.

There's a huge global market for this type of analysis, with more than 200 million lipid panels ordered annually in the U.S. alone. However, notes Dr. Shaw, it's an industry that's resistant to the kind of change he's proposing. Presently, the clinical chemistry industry operates on a "razor blade" economic model. Similar to razors and ink jet printers, the industry makes its profit on the sale of the consumable part of the product, in this case the chemical reagents.

Since Dr. Shaw's approach doesn't use reagents, the reception among traditional clinical chemistry industry players has been hesitant. But among potential users, including cardiologists, there's been a groundswell of interest.

Which is why he's partnered with a U.S.-based spectrometer manufacturer to develop the product. He's also established a business partnership with a clinical chemist who has experience in technology commercialization. Together, they're presently working on a prototype and hope to have the device into a variety of physicians' labs by early 2006 for initial clinical testing.

And while Dr. Shaw pursues his dream of seeing patients' get their blood lipid levels tested while they wait, scientists at the U.S. Centres for Disease Control in Atlanta can hardly wait for the results.

"They love it," says Dr. Shaw of CDC-Atlanta officials' response to the technology. "They think it has huge advantages, and they're keen to work with us as the devices move into clinical labs – including theirs."