Medical Device Daily Contributing Writer

Biomarkers have the potential to transform the diagnosis, treatment and monitoring of disease. But for this to happen, sensitive, low-cost, high-throughput screening systems are needed to detect and measure them.

A start-up company, QuadraSpec (West Lafayette, Indiana) has developed a system based on compact disc technology, which it said will overcome the tremendous measurement problems that have been thrown up by proteomics. The technology involves seeding the surface of CDs with antibodies and using lasers to measure the increase in the height of the surface when/if proteins in a blood sample bind to them.

The company will launch its first product – in the veterinary diagnostics market – early next year. It then plans to start a program to validate breast cancer biomarkers discovered by different research groups at the same time and said it will be able to offer tests for less than $2 each.

“The technology provides a way of exploiting the chemical history in the blood,” Fred Regnier, one of the inventors, told Medical Device Daily’s sister publication BioWorld International. “There are more than 1 million chemically distinct features in blood, and patterns of 10 to 100 proteins can tell a huge amount about the status of health, disease onset and progression, and the efficacy of drug therapy.”

While using biomarkers in this way is not a new idea, the concept has not made it through to clinical practice. Regnier, a professor of chemistry at Purdue University (Indianapollis), said there are two main reasons for this.

“Typically biomarkers are discovered in small groups of people and it is not certain that they are representative of the population as a whole, and currently only very expensive but low-throughput equipment is available to detect patterns of biomarkers.”

He added, “Validation is the issue, and the technology is not there to do that.”

Compact discs store digital information as billions of microscopic pits, representing binary ones or zeros, in concentric tracks across the disc. On QuadraSpec’s BioCDs each ring of pits can be seeded with an antibody.

After the CD is exposed to a blood sample, the disk is read to detect where there is increased mass, thus showing if, and how much, of any individual protein biomarker has bound.

The advantage of BioCD over other technologies currently in development, such as biochips, is the number of biomarkers a single disc could screen for, the price and the fact that it allows the volume of any biomarker to be measured.

Regnier claims also that the technique is far more sensitive than other optical techniques, such as surface plasmon resonance or integrated waveguides.

The BioCD technology was spun out of Purdue University to QuadraSpec in 2004. The company raised $1.5 million in seed funding and $6 million in its first private round in November 2005.

QuadraSpec has since developed a reader for the BioCDs that is roughly the size of a Sony Discman. Using that, the company claimed it is possible to measure up to 1,000 antigens, biomarkers, or other molecular species, and said the technology is scalable far beyond that point.

The overall aim is to develop the technology for carrying out doctor’s office tests to support personalized medicine. “The FDA is not ready for this yet, but we are suggesting you can use the technology to detect [disease] earlier, and in monitoring of therapy,” Regnier said.