Point-Of-Care Chemistry Ready To Transform Labs

This POC instrument suite offers a new value-added proposition for lab medicine

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CEO SUMMARY: Following on the heels of our prediction about web-based test ordering/results reporting, here’s another equally revolutionary development. CARESIDE, Inc. is ready to launch a point-of-care instrument suite for routine, high-volume chemistry and hematology tests. Early peeks at this technology reveal its potential to revamp the organization of both hospital and commercial laboratories.

WITH THE NEW MILLENNIUM comes innovative point-of-care technology which will decentralize laboratories and change the way clinical labs are currently organized and operated.

The technology is CARESIDE, Inc.’s revolutionary system for doing point-of-care (POC) chemistry and hematology tests. The company is now showing its POC chemistry solution at medical meetings throughout the country. It expects to ship its first instruments to customers within 90 days.

The CARESIDE Analyzer™, as the company calls its chemistry instrument, comes with 36 FDA-cleared or exempt tests and parameters. CARESIDE’s goal is to eventually offer a total of 55 chemistry and hematology assays.

As the POC chemistry analyzer comes to market, CARESIDE expects to have a POC hematology analyzer ready sometime during first quarter 2000.

“We plan to have three components to the CARESIDE lab system,” said W. Vickery Stoughton, Chairman and CEO of CARESIDE. “There will be a chemistry analyzer, a hematology analyzer, and a software solution which will connect both of these instruments to other lab instruments, as well as the various information systems in the lab or health- care enterprise.”

THE DARK REPORT predicts that CARESIDE’s POC analyzers will cause a radical change to the existing system of core lab/stat lab systems operated by both hospitals and independent commercial laboratories, for a fundamental reason. CARESIDE’s point-of-care analyzers are capable of performing the majority of high-volume, routine tests in a near-patient setting.

It appears that these instruments possess robust design quality and will deliver accurate results in a cost-effective manner. As a point-of-care solution, CARESIDE’s analyzers will allow doctors to get results in just 15 minutes, instead of waiting for the typical two to 24-hour turnaround needed in today’s clinical laboratory environment.

Decentralize Lab Operations

“From the beginning, our goal at CARESIDE has been to bring high-quality testing closer to the patient, and in the process, decentralize laboratory operations and reduce the cost of laboratory services,” explained Stoughton.

To accomplish this, CARESIDE used a classic application of the 80/20 Rule. “Most laboratorians know that a small number of routine, high-volume assays make up the majority of diagnostic tests performed each year in the United States,” noted Stoughton. “We identified the top 70 tests, by volume.

“Virtually all of these are routine chemistry and hematology tests,” he continued. “We designed our POC analyzers to perform these tests. This now makes it possible to reconfigure the organization of clinical laboratories in both hospital and commercial lab settings and move these tests out of core labs.”

Moving Chemistry Tests

The chemistry analyzer that CARESIDE developed is an elegant, simple solution for moving chemistry tests out of the centralized, high-volume laboratory. It is also compact, taking up less than one square foot of tabletop.

From first glance, it closely resembles the original MacIntosh computer of 1984. A plastic exterior case holds the touch screen window and a slot to accept the individual test cartridges.

THE DARK REPORT, in a site visit to CARESIDE’s headquarters in Culver City, California, watched the analyzer operate. It can hold up to six cartridges of a single patient’s blood at one time. Most cartridges contain one test, but some cartridges are capable of two or three tests. Under refrigeration, cartridges have a shelf life of about 18 months.

Test cartridges are a little smaller than the typical business card, and about 3/8 of an inch thick. The single use cartridge contains the reagent and uses channels to properly prepare the specimen, whether it’s serum, plasma, or whole blood. Sample sizes are small, about 75 to 100 microliters of whole blood.

Once the operator has loaded the cartridges and input patient information and test orders, the analyzer automatically launches cycles for heating, centrifuging, and several types of reading. Used cartridges eject from the side into a waste container. The entire process takes about ten to 15 minutes. Other details about this analyzer are listed in the side- bar on the opposite page.

Simple Analyzer To Use

“This is a very simple analyzer to use,” stated Thomas H. Grove, Ph.D., Executive Vice President of Research and Development. “It has been designed so that non-technical personnel, after appropriate training in the device, can operate and maintain it.”

Despite its ease of use, the CARESIDE Analyzer is actually a highly- sophisticated instrument, capable of meeting the expectations of the most sophisticated laboratorian. Dr. Grove explains. “Not only do we offer a comprehensive test menu, built upon the best testing technology, but we have invested considerable effort in the information management capabilities of the instrument itself.

“For example, we have embedded all the relevant quality assurance/quality control requirements affecting lab opera- tions, such as CLIA,” he said. “It is easy to develop Levey-Jennings charts and set the parameters for testing. We believe our analyzer can meet the needs of even the most demanding laboratorian.”

As of press time, CARESIDE’s chemistry analyzer has pre-market clearance for professional laboratory use of the CARESIDE Analyzer and 36 blood tests. There is a 510K submission with the FDA to obtain authorization for its use in point-of-care settings and physician office laboratories.

The hematology instrument is expected to be ready for market during the first quarter of 2000. CARESIDE is filing FDA applications sequentially for additional assays in chemistry, coagulation, and immunochemistry.

Marketing Trials

Marketing trials are about to start in a variety of settings. These trials will be undertaken at hospitals, large integrated healthcare systems, nursing homes, physician group practices, and home health care agencies. Marketing trials are intended to go beyond clinical trials data and demonstrate the effectiveness of the instrument system in actual day-to-day clinical use.

“Our planned menu of approved assays is intended to cover 80% of the types of blood tests ordered on an outpatient basis,” noted Dr. Grove. “We are now building up a sales force to introduce our products to laboratories throughout the United States.”

Cost of the CARESIDE Analzyer will be under $10,000. Individual test cartridges will have a retail list price of between $4.25 and $8.25, depending on the type and number of tests that a particular cartridge can run.

“Once final clearances are in place for our complete POC system,” stated Dr. Grove. “we expect it to be used by commercial laboratories, hospitals an
integrated delivery systems, physician offices, nursing homes, and similar care environments.”

End of Centralized Labs

Expect CARESIDE’s POC system to get a lot of attention, once laboratorians have a chance to evaluate it. THE DARK REPORT predicts that this new point-of- care technology, along with future competing products, will effectively mean the end of centralized laboratories doing routine testing.

This will change the structure and organization of hospital laboratories. It will also force independent commercial labs, including the two blood brothers, to radically revamp the way they provide lab testing services to physician offices.

For example, SBCL was preparing to put the CARESIDE system into some of its phlebotomy stations, located in physician office buildings. This would give it the capability to do rapid turnaround on routine testing and give it a competitive advantage over rival laboratories. It is uncertain whether Quest Diagnostics Incorporated, the new owner of SBCL, will pursue this business strategy.

Revolutionary Technology

Laboratory executives and pathologists should understand that this type of point-of-care testing technology is revolutionary. CARESIDE is first to market with its solution, but others will follow. During the next 24 months, this will become a highly competitive field.

The cumulative effect of pushing routine testing closer to the patient will be the end of centralized clinical laboratories as we know them today. It will bring about a change in the structure of both hospital labs and independent
commercial laboratories.

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