HAYWARD, Calif., Feb. 8 // -- Cholestech Corporation (NASDAQ:CTEC), the nation's leading provider of health management solutions for chronic disease, announces the launch of its new Dermatology Kit for use in monitoring the key health indicators of Accutane patients -- lipid and liver functions.
The need for accurate, real-time cholesterol and liver testing in Accutane patients is underscored by a recent study released by the University of California, San Francisco, and published in the Archives of Dermatology. The study concluded that abnormalities in cholesterol and liver enzymes in Accutane patients are even more prevalent than anticipated. Of the 13,772 patients monitored, all of whom began with normal lipid levels, 44 percent developed high levels of triglycerides, 31 percent developed high cholesterol levels and 11 percent developed abnormal liver tests. These alarming statistics make a strong case for testing in doctors' offices using instrumentation certified by the Cholesterol Reference Method Laboratory Network (CRMLN), the accuracy standard set by the Centers for Disease Control.
Launching this month, the Dermatology Kit from Cholestech contains everything dermatologists need to monitor the cholesterol and liver enzymes of Accutane patients during regular office visits. The kit features the Cholestech LDX(R) lipid and liver screening system, which is CLIA-waived and CRMLN-certified. The Cholestech LDX enables physicians prescribing Accutane to obtain laboratory-accurate blood results during routine office visits in under five minutes with a simple finger stick.
Each Dermatology Kit also includes 25 QuickVue Urine hCG pregnancy test kits from market leader Quidel Corporation. These pregnancy test kits allow dermatologists to comply with the FDA-mandated iPLEDGE program that requires those prescribing the drug to create a verifiable link between a negative pregnancy test and the dispensing of Accutane to female patients of childbearing age.
The real-time in-office risk assessment provided by the LDX system lets physicians determine the appropriate therapeutic course of action for elevated total cholesterol, triglycerides and ALT-AST (Alanine Aminotransferase- Aspartate Aminotransferase) levels without delay, allowing dermatologists to more effectively manage the severe side effects often exhibited by Accutane patients.
The Cholestech kit also addresses patient convenience. Since the kit allows for all testing to be done in the physician office lab, treatment can move forward immediately without the delay associated with sending blood samples to off-site labs, which can take several days for results to be returned. Receiving lab results in a timely manner avoids the need to reschedule office visits and postpone treatment.
"Many patients can benefit from the use of Accutane but their health must be protected with regular monitoring. Providing dermatologists with a comprehensive kit that provides real-time diagnostic tools for use during office visits creates a win-win situation for both doctors and patients. The urine hCG test kits provided, coupled with the LDX, have helped make this Dermatology Kit a convenient all-in-one resource for doctors," said Warren E. Pinckert II, Cholestech President and CEO.
About the Cholestech Dermatology Kit
The Cholestech Dermatology Kit contains everything necessary for conducting timely and accurate in-office cholesterol, liver and pregnancy testing, which includes the following items:
o (1) LDX System
o (5) Boxes of Lipid Profile Cassettes (enough for 50 tests / 10 tests per box)
o (5) Boxes of ALT AST Cassettes, 10 tests per box
o (1) Multi-Analyte Controls
o (25) Quidel QuickVue Urine hCG Test Kits
The Dermatology Kit also includes a Cholestech starter kit, which comes with every purchase of an LDX. The starter kit includes:
o (1) Printer to Print Test Results
o (1) Roll Printer Labels
o (200) Lancets for Fingersticks
o (4) Vials of Capillary Tubes (200 tubes / 50 per vial)
o (4) Vials of Capillary Plungers to Push Blood out of Vials
o (1) 35 Micro Liter MiniPet Pipette(TM) (draws the controlled fluid out of the vial)
o (1) Bag of 50 Pipettes
o (1) Accessory Tray
o (1) Optics Check Cassette
The MSRP for the Dermatology Kit is $2,850, a savings of $168 if the contents are purchased separately.
Cholestech is committed to enabling people to lead longer, healthier and more active lives. Cholestech provides easy to use, accessible diagnostic tools and information to health care practitioners in over 35 countries around the world. Cholestech offers efficient and economic diagnostic testing for cholesterol and related lipids, blood glucose and glycemic control, and liver enzymes at the point of care. Health care providers can use the CLIA-waived Cholestech LDX(R) and GDX(TM)* Systems and the hs-CRP test, which is cleared by the FDA for use in moderate complexity labs, to initiate and monitor the progress of patient therapy. By providing effective disease management solutions, Cholestech's goal is to be a leading provider of diagnostic tools and information for immediate risk assessment and therapeutic monitoring of heart disease, inflammatory disorders and diabetes. *The GDX system is 510(k) cleared for prescription home use and, accordingly, is CLIA waived.
NOTE: Cholestech LDX is a registered trademark and Cholestech GDX is a trademark of Cholestech Corporation. All other trademarks mentioned in this document are the property of their respective owners. For more information about Cholestech and its products visit us on the Web at www.cholestech.com.
Source: Cholestech Corporation
Web site: www.cholestech.com/
NOTE TO EDITORS: For information from expert, Warren Pinckert, call Heather Battaglia of HLD/Blankman Public Relations, +1-516-536-6811