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Kalorama: Vendors Try Small Footprint for New Clinical Test Products at AACC 2016

NEW YORK, Aug. 11, 2016 /PRNewswire/ -- From coffee-cup sized testing machines to a powerful handheld glucose reader, the introduction of new point-of-care (POC) diagnostic solutions was an evident trend at the American Association for Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo, which took place August 1–4 in Philadelphia, Pennsylvania, according to Kalorama Information.  The healthcare market research firm said that more diagnostic manufacturers have pursued approval of POC test devices over the past ten years, contributing significantly to the growth of the overall diagnostics market.   The firm found that the trend of increasing introduction of transportable, portable, and handheld instruments has resulted in the migration of POC testing from the hospital environment to a range of medical environments. The healthcare market research firm's recent report, The United States In Vitro Diagnostic Market.

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"Point of care is an attractive entry point where smaller innovators feel they can make a difference, and we saw that at the Expo," said Bruce Carlson, Publisher of Kalorama Information.

Abingdon, Nova Biomedical Corporation, Haemonetics Corporation, Spartan Bioscience, and Alere are among the companies that have worked to produce U.S. Food and Drug Administration (FDA) approved and CE Marked (free marketability in the European Economic Area) POC tests.

  • Abingdon Health's ADxLR5 Lateral Flow Assay reader is a next generation FDA-registered and CE-marked reader that incorporates a 10.1 inch touch screen with graphical user interface and icon driven software.  The reader also features USB ports and Ethernet connection. The company claims the sample draw with interchangeable and cleanable inserts allows for the reading of a wide range of devices.
  • Nova Biomedical Corporation's new StatStrip Glucose Xpress 2 as well as StatStrip Glucose are according to the company the only hospital glucose meters able to read glucose without interference from other medications that affect reads, and are for use with critically ill patients. Use of any other strip-based glucose meter with critically ill patients is considered "off-label" by the FDA and Centers for Medicare and Medicaid Services, according to the company's presentation.
  • Haemonetics Corporation's TEG 6s analyzer uses thrombelastography technology – a method of testing the efficiency of blood coagulation -- that the company claims significantly improves ease of operation while measuring the same viscoelastic properties – relating to both viscous and elastic characteristics – of blood coagulation. The all-in-one cartridge system delivers a comprehensive picture of interruption of blood flow (hemostasis) in near real time, giving invaluable insight so more targeted treatment can be delivered.  Its TEG Manager software allows secure remote access to patient results and analyzer/user administration.  The new TEG 6s system can be readily deployed in either near-patient or lab settings.
  • The epoc Blood Analysis System from Alere delivers blood gas and electrolyte results in about 30 seconds, according to the company.  It is a wireless and user-friendly bedside testing solution using smart card technology.  One of its key selling points is its shape (it is smartphone-sized) and its integration; wireless data integration delivers critical laboratory values seamlessly into the laboratory information system (LIS) and electronic medical record (EMR) in seconds.
  • The Spartan Cube is, according to Spartan Bioscience, the world's smallest DNA analyzer.  About the size of a coffee cup, the Cube's sample-to-result technology fully integrates DNA collection, extraction, and analysis, with an intuitive interface.  Spartan Cube preliminary assay menu includes Strep A – clinical, Legionella – water testing, and a PGx (personalized medicine test) assay for drug development.
  • Life Diagnostics' SPARCL is, according to the company, an ELISA solution that provides results in 45 minutes using a no-wash-step technology.

The healthcare market research firm's recent report, The United States In Vitro Diagnostic Market, contains information on point-of-care companies in the U.S. market and estimates of various segments of the POC market including pregnancy, glucose, infectious disease and other POC.  The report also looks at reimbursement trends.  The report can be found at http://www.kaloramainformation.com/United-States-Vitro-10133262/.  Kalorama publishes global reports as well.

About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.  

Contact:
Bruce Carlson
(212) 807-2622
bcarlson@kaloramainformation.com

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SOURCE Kalorama Information