Cholestech Announces FDA 510k Clearance for Alanine Amino Transferase Test.

HAYWARD, Calif.--(BW HealthWire)--Sept. 16, 1999--

Cholestech Corporation (Nasdaq:CTEC) announced today that the Food and Drug Administration has granted 510(k) clearance for the company's new liver function test, alanine amino transferase (ALT).

"We are very pleased to have our ALT test cleared for marketing by the FDA," said Warren E. Pinckert II, president and CEO of Cholestech Corporation. "We plan to begin marketing field evaluations during the next few weeks, and plan to file with the Centers for Disease Control (CDC) for waived status under CLIA by the end of September. We anticipate launching ALT within Europe, and as a moderately complex product in the United States, by the end of this calendar year. We plan to broaden our launch efforts in the United States if ALT achieves waived status."

ALT quantitative measurements are used by physicians in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. With the growing use of effective lipid-lowering therapies comes an increased need to monitor ALT. A side effect of these drugs can be a persistent increase in serum ALT levels, to more than 3 times the upper limit of normal, in about 1% of the patients receiving such therapy.

The company believes that, with the addition of the ALT test, the Cholestech L.D.X(R) System will soon be able to provide a new level of diagnostic testing convenience for healthcare providers involved with monitoring lipid lowering drug therapies.

The Cholestech L.D.X(R) is a telephone-sized device that can conduct multiple simultaneous diagnostic tests from a single drop of blood and provide results, in less than five minutes, that are as accurate as similar tests performed in clinical and hospital labs.

Cholestech Corporation manufactures and markets their proprietary system to healthcare, wellness, and disease management professionals for use in preventative care testing. The Cholestech L.D.X(R) System is positioned to benefit from the increasing emphasis on preventive health care and disease management. Cholestech's portfolio of CLIA-waived products is designed to offer efficient and economic diagnostic screening and therapeutic monitoring options that will ultimately enable people to lead longer, healthier, and more active lives.

Statements in this press release other than historical fact, including statements regarding: the timing and results of field marketing evaluations, the successful completion and potential timing of submissions to the CDC for waived status, whether or not the company's ALT test is granted waived status under CLIA, anticipated commercial launch dates for ALT, and the potential size, scope, or timing of the company's launch efforts are forward looking statements, the accuracy of which is necessarily subject to risks and uncertainties. Risks may include, but are not necessarily limited to: uncertainty regarding market acceptance of the company's new or existing tests, uncertainty regarding whether a CLIA waiver will ever be granted with respect to the ALT test or the timing of waived status if granted, uncertainty of future sales and profitability of ALT or other of the company's products, the timing and success of ALT, dependence upon third party suppliers and distributors, changes in government regulation, competition, risk of product liability or that product liability insurance may be insufficient, and the risks associated with the manufacture of new products, including capacity, acceptable yields, and the ability to meet acceptable product quality standards. Actual results may be affected by additional factors set forth in the company's Securities and Exchange Commission filings including the company's Form 10-K for the year ended March 26, 1999 and 10-Q for the quarter ended June 25, 1999.

Note to Editors: Cholestech L.D.X(R) is a registered trademark of Cholestech Corporation.