DÜSSELDORF, Germany – The current market is small and the laws are not clear, but two major medical device manufacturers moved into roadside testing for drugs-of-abuse with product introductions at MEDICA, the world's largest trade fair for medical devices.
Draeger Medical (Lübeck, Germany) showed a medicalized version of a test it launched in the law enforcement market earlier this year, while Philips Personalized Healthcare (Eindhoven, the Netherlands) introduced a hand-held drug test technology for law enforcement that it said will later prove to be a breakthrough in medical diagnostic applications.
Neither product will be released commercially until next year.
Both companies have an eye on the upward curve of roadside alcohol tests that reached 50 million units this year worldwide.
As public awareness for the dangers of driving while under the influence of drugs increases, the companies are betting that public tolerance for such behavior will fall and remove any remaining legal barriers to widespread roadside screenings.
In Victoria, Australia, random roadside screenings revealed that one driver in every 200 was legally drunk but that one in every 46 was high on something else.
Both products are saliva-based tests that can be performed through the driver's window and return a positive-negative result for opiates, cocaine, amphetamines, methamphetamine and THC, the active ingredient in the market-leading drug-of-abuse, marijuana.
This contrasts with alcohol testing that returns a quantitative result used for legal thresholds of a driver's impairment.
The Draeger test also includes a test for benzodiazepines, which are found in driver-impairing prescription drugs such as valium.
While sharing this common ground, the two testing platforms diverge significantly.
The Draeger test is a sophisticated adaption of the familiar test-strip technology, while the Philips test is based on the familiar technology of a DVD reader but adapted for an advanced application.
Recalling that the consumer products division of Royal Philips Electronics played a role in the development of digital versatile disc (DVD) technology, and that it is working on the next generation, Jos Rijntjes, general manager for point-of-care cardiac testing with Philips' Health Care Incubator in Eindhoven, said a DVD player "actually is a source for beautiful, and cheap, optics."
The MAGNOtech platform Philips has designed quietly over several years for diagnostic assays uses the disposable injection-molded plastic cards common to point-of-care diagnostics.
The first application is for saliva drug testing, he said, in cooperation with Concateno (Oxfordshire, UK), a leading provider of such tests and the only one currently offering a hand-held analyzer being used in Australia.
In parallel, Rijntjes said Philips' POC group is developing medical applications.
Two distinguishing features of the new DVD-based technology platform are manipulation of targeted solutions sandwiched in the assay card, and then the fast optic scan of the resulting reaction with agents in the solution.
A sponge swab gathers the saliva sample and placed into a cartridge is squeezed onto the assay card.
A magnetic field in the reader forces the liquid to interact with agents in the solution that bind themselves to the targeted drug compounds, if present in the sample.
"The trick is that we move these particles, which now have a magnetic property because of the nano agents bound to them, through the solution 100 times faster" than a natural diffusion model, Rijntjes said.
The second technique, he said, is the ability to scan the surface of the card and see only the particles that are bonded.
A second magnet gathers the particles bound with the agents identifying them as a positive reaction in a circular patterns centered on the sandwiched assay layers. A light-emitting diode laser (LED) scans the surface and its wavelengths are reflected to a detector.
"It is so sensitive, and fast," Rijntjes said, requiring just 90 seconds for the roadside drug test.
And, critically, he said the lightweight scanner is truly hand-held, bringing the device to the patient, or in this case, a suspected perpetrator of a traffic violation.
The medical applications for the new DVD-optics platform are unlimited, he said, adding that after trying saliva and urine assays, the Philips POC development team decided to focus on blood-draw applications.
"We only need a 15 microliter droplet and in five minutes we can give results," Rijntjes said, for example for patients with chest pains using a cardiac troponin marker. "It is 100 million times more sensitive than a common glucose blood test," he said.
The device will prove valuable for its ease of use and for its portability, he said. "It can be used where speed is critical, and it can go where it is needed," he said, citing as examples a physician's office for screenings, or with a visiting nurse into a patient's home.
Neither the MAGNOtech platform nor the assay tests developed by Concateno have either a CE mark or FDA approval.
The partners also will be seeking a CLIA waiver so personnel not trained with a specific medical skill set can do the test.
Karon Hawthorne, marketing manager for the Philips project with Concateno, said the test will be commercially available at the end of 2009.
Concateno works in two of the world's few markets with a mandate for drug testing, she said.
Britain's Home Office has since 2001 required drug testing of all prisoners to separate those who may benefit from drug counseling from those whose crimes were influenced by other factors.
"Curiously, in the United Kingdom we do not have legislation allowing roadside drug testing and therefore can not prosecute based on results of testing," Hawthorne said.
She said Concateno receives about £2.5 million ($3.7 million) on the Home Office contract and another £500,000 ($743,000) in the Victoria, Australia, program.
"There have been a lot of articles recently in the UK about roadside testing for drugs," she said, "Clearly the issue is moving up the agenda."
David Browning, CEO of Philips Personalized Healthcare in Eindhoven, said a joint development agreement for the project with Concateno was started in 2005, with a public announcement for a partnership in January 2006.
An agreement to jointly sell the drug test product was signed in June 2007.
He said Philips started early and is committed to Concateno because "they are the market leader." At Philips, we see that it is critical to set the standards in a market that we enter," he said. "This hand-held unit and the technology onboard is going to become that standard, versus the test strips used widely today."
As for the new diagnostics being developed for medical markets, Browning said, "I cannot speak to what we are working on, but we will be announcing something by the end of 1Q09."