By Tom Henderson
Small Times Senior Writer

Jan. 15, 2002 — Officials of Osmetech, a British maker of an electronic nose approved for use by the U.S. Food and Drug Administration in November, are hosting a series of potential American partners this week.

They hope to sign an agreement soon and begin distribution this year of a point-of-care sensor to detect urinary-tract infections.

A second device, to detect bacterial vaginosis (BV), is currently undergoing FDA trials. Company officials hope to submit it for approval in April and begin marketing the sensor before the end of the year.

Andrew Onderdonk, a professor of pathology at Harvard Medical School and director of microbiology at Brigham and Women’s Hospital in Boston, has been part of both FDA trials.

“In the case of urinary-tract infections, we’ve been looking for a reliable screening method for a long time,” Onderdonk said. “There are other screening methods out there, but they don’t work very well.”

He said that about 50 million tests for urinary-tract infection are performed each year in the United States. They can take days or even weeks to come back from the lab, versus an almost instantaneous result from Osmetech’s electronic nose.

Onderdonk said FDA tests on the sensor showed a 96 percent success rate for urinary-tract infection and preliminary tests show similar results for the BV sensor.

“This will be a point-of-care instrument that will become the gold standard,” Onderdonk said. Clinical trials are also being conducted at Johns Hopkins Hospital in Baltimore.

Osmetech was founded in 1994 as AromaScan, based on research at the University of Manchester Institute of Science and Technology. It went public on the London Stock Exchange the same year.

It bases its sensors on conductive polymers. As vapors bind to the polymer, its conductance changes. Proprietary software developed by the company interprets that change and makes a diagnosis, said James White, the company’s chief executive.

He said the company wants to concentrate on developing and testing other sensors, including one for detecting pneumonia in an intensive-care setting and one with various wound-care applications, and leave the actual marketing and selling of devices to a partner.

The prototype devices are about the size of the bottom of a coffee cup and incorporate up to 48 polymer sensors. The number of sensors and their characteristics are specific to each approved application.

White said that the FDA approval in November was critical in keeping his company afloat. On Nov. 23, the London brokerage firm of Teather & Greenwood Ltd. issued a “strong buy” recommendation.

White said Osmetech, headquartered in Crewe, near Manchester, had pinned its global efforts on U.S. approval.

“FDA approval is a benchmark for health care, globally,” he said. “Once you get that, you can take aim at other markets. You start at the top and work back. You talk to people in Japan and they say, ‘Do you have FDA approval?’ And it’s the same in Europe.”

Onderdonk said that having a BV sensor approved would give Osmetech “a huge market to go after.”

Current methods of detecting it at the point of care are so unreliable, he said, “you’d almost do as well by flipping a coin.” He said that primary-care physicians can test for PH levels, look for discharge and seek abnormal clue cells in a tissue smear. But in practice, he said, most doctors make their diagnoses based on their patients’ description of symptoms.

Onderdonk said that the BV sensor will eliminate costly and time consuming lab tests done routinely to corroborate point-of care diagnoses.

“At Brigham and Women’s we do 75,000 to 80,000 lab tests for BV each year, and 80 percent of them are negative,” he said. “The real value to the test is it can tell you which ones are negative.”

BV is generally a mild infection, but untreated it can spread to the uterus or fallopian tubes and cause serious health problems, such as fetal complications in pregnant women and higher risks of post-operative infections in women having hysterectomies or abortions.

Onderdonk said that clinical trials for the BV sensor end in February, with reports to the FDA to follow.

Osmetech employs 30 at its headquarters, has three employees in Boston to support U.S. testing and has 10 contract researchers, in Cleveland, Seattle and Boston.

White said that the company was delayed getting a product ready for market because it was too unfocused in the years after its founding. “They tried to go into a wide range of areas, including industrial applications, before the technology was robust enough,” he said.

He was hired three years ago to focus the company’s technology and decided to take aim at the health-care market. He was elevated to chief executive a year ago.

The company doesn’t expect to generate revenues from its sensors until 2003. Officials say it had enough cash reserves as of early January, about $5.8 million, to last eight or nine months. And they say it has secured an equity line of credit of $7.2 million for a U.S. firm to take it into 2003.

White said he doesn’t expect to have to tap into that line of credit, anticipating a deal with a large U.S. partner.

“We had a bump in interest when we applied to the FDA last April, and in November, when we got approval, there was quite a bump in interest,” he said.

“There are a number of people keen to do something. We’re looking to find the right partner, rather than settling on the first person through the door with a check.”

Osmetech is one of at least a dozen firms marketing electronic noses, including Cyrano Sciences Inc. of Pasadena, Calif., Alpha MOS of France and AppliedSensor of Sweden.


Tom Henderson at [email protected] or call 734-528-6292.


Easily post a comment below using your Linkedin, Twitter, Google or Facebook account. Comments won't automatically be posted to your social media accounts unless you select to share.