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Cholestech Corporation and Bayer Diagnostics Announce Co-Marketing Agreement to Increase Diagnosis of Cardiovascular Disease and Diabetes

Bayer Corporation, Diagnostics Division and Cholestech Corporation

(NASDAQ:CTEC), announced today the launch of a joint national program aimed at increasing the "in-office" diagnosis and management of diabetes and cardiovascular disease. The "Risk Management Program" is designed to offer more than 100,000 physician office laboratories and acute care facilities access to the Bayer DCA 2000 + Analyzer for diabetes management and the Cholestech L-D-X System for lipid management, through both companies.

CLIA-Waived Microalbumin Urine Dipstick

Diagnostic Chemicals Ltd offers a high negative predictive value rules out diabetic nephropathy.  The ImmunoDip combines the simplicity of a dipstick with the accuracy and reliability of monoclonal antibody technology.  The American Diabetes Association recommends that this test be done annually in all high-risk patients with positive results confirmed by more specific methods .

Microcoagulation System for Point-of-Care

International Technidyne has added the ProTime3 POC device to its ProTime Microcoagulation System.  This device monitors the Prothrombin Time (PT) of patient’s blood.  This is critical for patients who are on Coumadin therapy.  This test may be performed in the physician’s office, a clinic, or at the home by the patient or caregiver.  

Self-Adhesive Lab Report Labels

Data Management, Inc offers adhesive ‘medical forms on a label’ come in several sizes and may be used to easily manually record results on a patient’s chart.

Medical Automation Systems Announces Vendor-Neutral Point-of-Care Data Management Position

Medical Automation Systems (MAS; Charlottesville, VA) has announced that they positioned themselves with all of their business partnerships and strategic alliances so that all point-of-care devices can be integrated into the company’s state-of-the-art RALS^®-Plus data management system.

“Our goal from the inception of our business in 1994 was to provide data management solutions for all point-of-care testing,” said Gregory A. Menke, MAS President and CEO.  “We started the business supporting just critical care applications , then we added the glucose  analyte  with RALS-G and  now we have come full circle back to a total vendor neutral position for all point of care applications with RALS-Plus.”

In the Spring of 2001, MAS plans to launch the first version of RALS-Plus, a modular designed, vendor-neutral information management system.  The devices included in the initial launch will be all of the Roche Diagnostics glucose devices including the new AccuChek Inform, the Roche CoaguChek Pro DM for coagulation, the Roche Chemstrip 101 and the AVL Opti for blood gas.  Additional devices, such as Biosite’s Triage System for cardiac and congestive heart failure markers, ITC’s Hemachron coagulation devices, Bayer’s Clinitek 50 urinalysis device, and a full range of manual tests will be introduced in versions of the RALS-Plus software scheduled for release throughout the first year.  Ultimately, RALS-Plus will interface to all manufacturer’s point-of-care devices and applications, including glucose.

MAS will continue to support the relationship they have developed with Roche Diagnostics over the past three years.   “We have nearly 250 RALS-G glucose data management customers connected to Roche devices throughout the U.S. and Canada and we will continue to support those customers and the Roche sales and marketing efforts,” Menke says.  “We greatly value the relationship we have developed with Roche over the past several years and have no desire to change that.”

Medical Automation Systems (www.medicalautomation.com) is a privately held company formed in 1994 by licensing RALS^®, a Remote Automated Laboratory Systems technology from the University of Virginia. The company is based in Charlottesville, Virginia and currently employs 115 people.  

Careside and Quest terminate exclusive contract and explore point of care opportunities

Careside Inc. of Culver City, California and Quest Diagnostics of Teterboro, New Jersey has terminated the exclusive distribution and supply contract they both inherited when Quest acquired SmithKline Beecham Clinical Labs in 1999. Careside, an offshoot of SmithKline informed Quest it was nearing attainment of all developmental milestones for contract activation, but Quest was not ready for contract activation. Hence, Quest exercised its right to cancel the contract. Careside is assisting Quest in its evaluation of the POC market and Careside’s POC technology.

Glucose Meter Calibration – Instrument added to assay

To help in meeting CAP requirement for calibration verification, Streck Laboratories has added an analyzer to the Sugar-Chex Control assay.  LifeScan FastTake is now included on the assay with the LifeScan One Touch II and SureStep Pro; Bayer Glucometer Elite, Glucometer III, Glucometer Encore and Encore QA Plus; Medisense Precision G, Precision QID and Precision PCx; Roche Accu-Chek, AccuChek Advantage and Accutrend. Sugar-Chex Control is available at three levels to test the daily quality control of glucose meters and to provide a quick method to verify calibration. The control has a 15-month closed vial stability and a 30-day open vial stability when stored at room temperature. It performs like whole blood, eliminating the matrix affect often seen in aqueous products. 

Hand-Held Device for Measuring Bilirubin in Infants

The handheld BiliCheck (SpectRx, Norcross, GA) for measuring bilirubin in newborns.  The device is held against the infant’s forehead and completes the test in 15 minutes.  The measurement is conducted through the skin; no blood is drawn.

New Whole Blood Analyzer

The INRatio system (Hemo/Sense, Milpitas, CA), a whole blood analyzer designed for patient use that measures prothrombin time (PT) and calculates the international normalized (INR).     

New Device from Hemoscan

The Hemoscan (Cytometrics, Philadelphia, PA) a portable device for measuring hemoglobin, hematocrit and white blood cell count, through a thermometer-like probe placed under the patient’s tongue. 

Immunoassay System Cleared for Marketing

The FastPack System, a point-of-care blood testing system from Qualigen, Inc. (Carlsbad, CA) has received marketing clearance from FDA.  The automated analyzer performs quantitative immunoassay tests for total PSA and provides results in less than 15 minutes.

FDA Gives Nod to Diabetes Control System

LXN Corporation (San Diego, CA) has received FDA clearance to market its In Charge Diabetes Control System, a home test that measures both glycated protein and blood glucose using a small, hand held meter.

H. Pylori Test Receives CLIA-Waived Status

Trinity Biotech’s (Dublin, Ireland) Uni-Gold H. pylori test has received waived status from the CDRH, which allows sites with certificates of waiver to perform the test at point-of-care using whole blood samples.  The company’s Uni-Gold H. pylori test screens for the presence of IgG antibodies to the bacterium Helicobacter pylori. 

Hand-held Cholesterol Monitor Given 510(k)

Lifestream Technologies (Fort Collins, Colorado) has received 510(k) clearance from FDA to market the Cholestron Pro, a hand-held instrument that screens and monitors blood cholesterol levels from one drop of blood in about three minutes.

Sunquest-Data Critical Agreement

Sunquest Information Systems has signed an agreement with Data Critical Corp. under which Data Critical will market Sunquest’s Clinical Event Manager, a wireless, Web-enabled clinical alerting system that automatically sends clinical data to clinicians via pager or e-mail.  

Lifecan Introduces SureStepFlexx Glucose System

LifeScan Inc. has introduced the SureStepFlexx blood glucose monitoring system with DataLink connectivity options that are also compatible with LifeScan’s original One Touch II Data Dock hospital system.

LabPortal.com has introduced an Internet-based clinical laboratory connectivity product

LabPortal.com has introduced an Internet-based clinical laboratory connectivity product for integrated delivery networks in hospitals and regional commercial laboratories.  The product allows physicians to order laboratory tests and access results from any computer with a Web Browser.  Advanced functions include verification for medical necessity and checks for coding discrepancies.