Point-of-Care Technologies
POC testing takes on immunochemistry
  Sidebar: What CLIA Wrought Thyroid Disease Facts In the United States, the quality of patient testing is ensured through the body of regulations that implemented the Clinical Laboratory Improvement Amendments of 1988 (CLIA). For physician office laboratories (POLs), however, enactment of CLIA has proven to be a two-edged sword. While the legislation addressed concerns about the quality of patient testing, it also made it difficult for POLs to maintain testing...
POC connectivity standard approaches the finish line
Last year, the Connectivity Industry Consortium (CIC), an IVD industry group comprising device manufacturers, information system vendors, and healthcare providers, set out to establish standards that create a universal way to integrate point-of-care (POC) data with laboratory information systems. Now, a year later, the CIC has managed to accomplish that goal, and new connectivity standards are on their way to being formally accepted and published. The need for such standards was made apparent...
Connectivity of diagnostic systems: A better future is in sight
    Ray Jones is program director for medical information systems at Colorado MEDtech/RELA (Boulder, CO). A central issue for point-of-care (POC) diagnostic devices in recent years has been the connectivity of individual devices to other diagnostic systems or information systems. Each individual vendor has generally implemented a connectivity solution specific to its own product. In certain cases, the vendor provides other data management products specific to the same...
Betting on innovation
W. Vickery Stoughton is chairman and CEO of Careside Inc. (Culver City, CA), manufacturer of a platform instrument for point-of-care testing of blood samples. He can be reached via stoughtonv@careside.com.   The IVD industry is replete with entrepreneurs and start-up companies, many with outstanding technologies or products in the pipeline. Unfortunately, for some of these companies the costs and tribulations of developing products for a highly competitive market will...
GlucoWatch receives FDA approval
  Glucowatch Biographer by Cygnus (Redwood City, CA) The movement toward bringing a truly noninvasive method for measuring blood glucose levels to market has just taken a big step forward. In March of this year, the GlucoWatch Biographer from Cygnus Inc. (Redwood City, CA) became the first noninvasive glucose monitor to clear regulatory hurdles and receive approval for marketing in the United States. The system will be sold as a prescription device for adults with diabetes. The...
LifeScan fined for defective glucose monitor
        For the second time in less than two years, FDA has hit a major IVD manufacturer with a substantial fine for noncompliance with the requirements of the agency's quality system (QSR) and medical device reporting (MDR) regulations. In the most recent instance, LifeScan Inc. (Milpitas, CA), a wholly owned subsidiary of Johnson & Johnson (New Brunswick, NJ), pleaded guilty in federal court to civil and criminal charges relating to a government investigation of the...
New rule boosts POC drugs-of-abuse testing
  Manufacturers of drugs-of-abuse tests for use at the point of care (POC) are preparing for a shake-up in the U.S. workplace testing market. Test services in this $450 million market are dominated by 66 laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMHSA). The largest of these laboratories are LabCorp (Research Triangle Park, NC), Quest Diagnostics Inc. (Teterboro, NJ), and LabOne Inc. (Lenexa, KS). The Department of Health and Human Services (...
Microfluidics-based lab-on-a-chip systems
  Miniaturization and automation have revolutionized the world of microelectronics. Whereas computers once were room-sized, steady technological advance has led to laptops, palmtops, and even game consoles that are much more powerful than were those behemoths of the 1950s and 1960s. But until recently few of these cutting-edge engineering technologies have been applied to the needs of the medical diagnostics laboratory. Consequently, much laboratory work long remained—and some still...
Automating POC instrumentation: A systems view
Paul Harris and Joanne Stephenson By bringing together advanced componentry and technical sophistication, the current generation of point-of-care instruments is making significant headway toward improving clinical diagnostics. Among clinicians, the gradual growth of point-of-care (POC) testing represents an opportunity to dramatically improve the quality of patient care for a variety of diseases and conditions. Especially in settings where clinical decisions are time critical, healthcare...
Industry consortium developing standards for POC device connectivity
Dirk Boecker and Emery J. Stephans Point-of-care (POC) testing is among the fastest-growing segments of the IVD industry. As of 1998, there were roughly 150,000 CLIA-licensed POC-testing sites in the United States alone, and the worldwide market was estimated to be about $1.7 billion. The U.S. portion of that market was roughly $1 billion and growing at a 12–16% annual rate via the deployment of new tests and the displacement of traditional central-laboratory work. Advances in...