BIRMINGHAM, England, Aug. 23, 2002 — Diagnostic tests on patients at or near the site of their care face three major barriers if they’re ever to become a reality: continued funding, approval from U.S. and European regulators and eventual “manufacturability.”
At Brunel University in London, Professor Wamadeva Balachandran’s research team expects its Doctor-on-a-Chip (DoaC) to be commercially viable by 2005.
Originally called a Lab-on-a-Chip, people confused it with the plethora of other labs-on-a-chip being developed around the world, so he changed the name to DoaC, saying his product is a very specific lab-on-a-chip subset.
Balachandran is talking with potential investors and licensees. “I think whoever comes on board as the licensee will have to be responsible for getting the FDA approval. Our role, as a university, is to do the R&D and clinical testing.
He explained that the European Union has its own approval process for such devices, but “if FDA approval is given, you can sell it anywhere in the world. If you really want to market it successfully you’ve got to have the FDA approval.”
“In U.K. universities, we have to work on a shoestring budget until we can dangle a carrot to attract more funding,” he said. “Hence we’ve done some preliminary work to demonstrate at least one aspect of the chip.” But, Balachandran said, the overall problem is “trying to determine how much intellectual property detail I can provide the VCs. We’ve applied for a patent and the examination is now under way.”
Professor Calum McNeil of the Institute of Nanotechnology, and the University of Newcastle upon Tyne estimated FDA approval would take “at least two years from a commercial prototype,” which, he added, could need as much as “another two years to be clinically tested.”
“The diagnosis market is huge,” said J. Malcolm Wilkinson, managing director of Technology For Industry Ltd. in Cambridgeshire, England. “But it takes time to develop the technology, get the regulatory approval and then change the paradigm of the health care laboratories/clinical staff.”
Bob Mariner, managing director of VLSI Research Europe Ltd. in Bedford, has a more positive view.
“There are of a number of organizations working on products for bio-analysis using MEMS based technology such as this,” he said. “If the final product proves to be effective and reliable it will drive a fundamental change in medical diagnosis.” Mariner warned of an “excess of exciting prospects and a lack of viable products.” But, he added, “use-once medical sensors such as these will probably” could remedy that situation within the next five years.
Portable analysis devices reduce the time and cost spent obtaining routine medical tests, Balachandran said. “The concept here is doctors can do this while still talking with their patient.” The doctor would place a drop of the patient’s blood on the front end of a polymer chip, the size of a credit card and wait five or 10 minutes for the chip to do its tests and display the results.
Early models of the chip will check for various kinds of viral infections sequentially — the health care worker keying in whichever type of virus he thinks it is, and if a negative response results, keying in another possibility. Eventually, Balachandran expects the DoaC will have the ability to automatically to run through a whole series of tests for various viruses.
Perhaps the biggest obstacle Balachandran’s DoaC will face will be when it comes time to manufacture and distribute the chips, McNeil said. “In the U.K., for a microsystem, the facilities for that type of volume just don’t exist. I would imagine it would have to go to Singapore or Taiwan to actually get made and then bring it back and repackage it here or in the States and then try to sell it. And that’s a major problem.”