Cholestech files petition with Centers for Disease Control and Prevention to classify tests as waived under CLIA '88.HAYWARD, Calif.--(BUSINESS WIRE)--Feb. 13, 1995--Cholestech Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CTEC CTEC Course and Teacher Evaluation Council (Northwestern University, Office of the Register) CTEC Certified Technical Education Center CTEC Certified Technical Education Center (Microsoft) ) announced today filing a petition with the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation ) to reclassify Verb 1. reclassify - classify anew, change the previous classification; "The zoologists had to reclassify the mollusks after they found new species" class, classify, sort out, assort, sort, separate - arrange or order by classes or categories; "How would you its total cholesterol, HDL cholesterol HDL cholesterol n. See high-density lipoprotein. HDL Cholesterol About one-third or one-fourth of all cholesterol is high-density lipoprotein cholesterol. , triglycerides Triglycerides Fatty compounds synthesized from carbohydrates during the process of digestion and stored in the body's adipose (fat) tissues. High levels of triglycerides in the blood are associated with insulin resistance. and glucose tests from moderately complex to waived under CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a '88. The petition was filed pursuant to a December 19, 1994 announcement that the CDC has resumed reviewing requests for waiver of specific CLIA requirements for laboratory testing devices under existing CLIA regulations. The December 19 announcement also included guidelines that the CDC will use for verifying performance characteristics related to accuracy and precision of the testing device. Under these guidelines the test system must demonstrate adequate accuracy and precision, that it "is simple" and "has an insignificant risk for an erroneous result." Commenting on the submission, Warren E. Pinckert II, Cholestech's president and chief executive officer said, "We are pleased that the CDC has lifted the moratorium on classifying testing devices as waived tests. We have been working with the CDC on this issue and are now happy to make a submission addressing the specific CLIA requirements and the recently published guidelines. We believe our data package demonstrates the Cholestech L.D.X System is simple to use and has a low probability of giving an erroneous result. "Everyone should understand that the review process is new to both the CDC and to the companies that will submit requests for waiver. Since the process is new, we expect there will be questions and even possibly requests for additional data from the CDC. We will work closely with the CDC and assist them as best we can in the review process." Continuing, Pinckert stated, "Given the new process and criteria, it is impossible to predict how long the CDC review process will take or if the Cholestech tests will meet the new criteria and be classified as waived. Moreover, the December 19 letter notes that a final rule on waived test criteria has not been established and published. Therefore, if final rule criteria differ from current criteria, any test receiving waived classification under the current process would be re-evaluated against any new regulations or criteria published in the final rule." On the effects of waived classification, Pinckert said, "Because of the significantly reduced fees and regulations, we believe waived classification would yield three benefits. First, will be a reduction in the operating cost of performing tests on our system to our existing domestic customer base. Secondly, potential users who previously have found the cost of using our system too high in relation to the number of tests they perform may now find testing profitable. Lastly and most importantly Adv. 1. most importantly - above and beyond all other consideration; "above all, you must be independent" above all, most especially , we believe that lower cost of testing will result in more access to preventive health care and ultimately in lower health care costs in general." Cholestech Corporation is committed to helping people lead longer, healthier and more active lives by promoting simple, quick and accurate monitoring of blood-detected diseases and disorders in the point-of-care setting. Cholestech Corporation develops, manufactures and sells diagnostic systems worldwide. CONTACT: Cholestech Corporation Lola Moenich, 510/293-8096 |
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