IVD Technology Magazine | IVDT Article Index
Originally published January 1996
NEWS
Plucking the point-of-care plums
Most point-of-care (POC) devices are coming from small, often single-product companies that skip nimbly between the feet of their slow-moving corporate-giant competitors. To stay on top of the food chain, some of those giants have been scooping up their smaller rivals, through acquisitions and licensing agreements that benefit both. Haemoscope Corp. (Skokie, IL), for example, drew a crowd at this winter's American Heart Association (AHA) meeting in Anaheim, CA. Their instrument has become a staple item at many transplant centers, yet no more than a handful of people man the corporate headquarters. A typewriter-sized device that reads whole-blood coagulation to distinguish between routine blood loss and heavier bleeding during surgery, the product now is making its way into smaller-scale surgical sites and birthing centers, says Carole Cohen, a member of the Haemoscope force. Her husband Eli, a college professor turned entrepreneur, is part owner of the company.
There is a general industry- wide failure to miniaturize and render more portable the machinery for which some corporations are so famous, from blood-gas to lipid analyzers, affirmed representatives from C. R. Bard, Inc. (Billerica, MA), Sigma Diagnostics (St. Louis), and Sony Electronics, Inc. (Montvale, NJ), who gathered at AHA's meeting. Some attribute this to a cumbersome corporate hierarchy--company cultures that stifle instead of spur this kind of research.
"But it isn't a matter of just reducing the size," says one. Turning the same instrument used by laboratorians into a near-pocket-sized version "isn't even the same technology." It's easier just to scour the terrain for new technology than to modify traditional large devices.
Jay M. McDonald, MD, chair of pathology at the University of Alabama at Birmingham, has been studying this relatively new industry-- POC testing--as a growth area over the past several years. In an analysis published last year in the journal Clinical Chemistry, he predicted a rise in POC testing, and not just at the bedside. Home care will be its next stop. This development, he asserted, is "here to stay."
Although McDonald based his conclusions on a careful academic review, his own 780-bed medical center provides convincing evidence of the trend. A majority of beds have some kind of POC testing system, he noted. At any given time about 100 are equipped with a handheld analyzer that uses a biosensor to test blood within two minutes. The telephone-sized device, called the i-STAT system from i-STAT Corp. (Princeton, NJ), requires only two to three drops of blood to perform a panel of blood tests.
To maintain quality assurance, periodic testing is conducted on the i-STAT system, as well as on other POC machines. A "Bedside Testing Office," which McDonald helped institute, monitors and evaluates this emerging technology as it is implemented and used. In the future, big buyers--like McDonald's medical center--are going to consider not only cost, capability, and service but also "user interaction," including a hotlined home base, so that hospital staff more safely can assume a laboratorian-type role, McDonald pointed out in his article.
But couldn't a small company with a really good POC system provide the same support? Not likely, says noted industry-watcher Kenneth B. Lee, Jr., cochair of international life sciences at Ernst & Young (Palo Alto, CA).
Lee, who has been studying the transformation of biotech companies from small to major, believes most follow a common trajectory. A scientist, usually an entrepreneurial corporate maverick or an academician with a hot idea, takes an innovation from concept to reality. If the newborn product makes it through the regulatory maze that defeats so many, it is "swing-factor time"--the period in which effective marketing can spell the difference between success and failure.
This is when many companies lose their toehold, Lee says. "Those who have that pioneering spirit are often people who don't do well in a structured environment," he explains. They need a larger corporation to keep the momentum going and to market the product.
That's a problem a product named the Piccolo currently may be facing, according to a profile printed in the Wall Street Transcript last January. Produced by Abaxis, Inc. (Sunnyvale, CA), the Piccolo system is billed as the first portable blood analyzer and boasts a single-use reagent rotor that allows for a panel of 12 blood tests.
According to Chuck Caterino, Abaxis's director of sales and marketing, the Piccolo won't compete directly with the i-STAT system, which is largely in hospitals, but will chase the physician-office market instead.
Abaxis is something of an industry phenomenon. The company went public in 1992, three years after its founding, with only a prototype to show investors. Stock was priced at $11 a share, a relatively high price for a company with an unproven product. Now Abaxis appears to be in the crucial swing-factor period, following FDA clearance of the Piccolo last year. As of November 30, the stock was selling at $5.50 a share, half the initial public offering price.
In i-STAT's case, that transition may, in part, be eased by a recent agreement with Hewlett-Packard (Lawrence, MA), which forges both a technological and a marketing collaboration between the two companies. Under the agreement's terms, HP will market the i-STAT system in Europe, Africa, and the Middle East. Future applications could combine it with HP's new wireless communications system, which relays data to a palm-sized computer that physicians can carry.
And the i-STAT system has benefited in another important way: word of mouth. When it was tested in Canada, the emergency-room personnel at University of Alberta Hospitals liked it so well that it was placed in neonatal intensive-care units, too, notes Thomas Mock, PhD, of the university's biochemistry department, who helped conduct the validation studies.
The i-STAT system performed so well in terms of the linearity and precision of its hematocrit measurement from samples of whole blood that it now flies on patient-transporting helicopters, too. The system proved about as reliable as the Kodak Ektachem 700 xr, which depended on a central lab, Mock says.
This new POC product has captured a sizable chunk of the hospital market. It is in more than 600 hospitals already.
Johnson & Johnson Clinical Diagnostics (Rochester, NY), which bought the Ektachem technology, is fighting to keep its grip, though. According to Richard Lees, the division's communications director, the new Ektachem DT60 System is portable enough to serve currently on military cargo ships and planes. It can be hauled into mobile army and navy hospitals without any interference with the reportable results, he adds.
But i-STAT does not consider the DT60 to be much of a competitor, says Michael Wagner, i-STAT's market- ing communications manager. J&J's desktop unit is more cumbersome, not "something you could fit in a fanny pack" like i-STAT's, he contends. --Anne Scheck
