Celera Files U.S. Regulatory Application for KIF6 Genotyping Assay
ALAMEDA, CA - January 03, 2011
Celera Corporation (NASDAQ:CRA) today announced that it has submitted a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for its KIF6 Genotyping Assay, a new molecular In Vitro diagnostic (IVD) test designed to detect a marker for risk of coronary heart disease (CHD) independent of traditional risk factors and aid clinical evaluation when statin treatment is being considered.
"We're pleased to have filed for regulatory approval on our KIF6 Genotyping Assay in line with our year-end goal," said Kathy Ordońez, Chief Executive Officer of Celera. "This test has been designed to contribute to the prediction of risk for coronary heart disease and response to statin therapy".
Celera is seeking regulatory approval to perform the KIF6 Genotyping Assay on Abbott's m2000™ instrument system. More than 870 m2000 systems have been placed in laboratories worldwide. In June 2010, Celera signed a Declaration of Conformity and applied the CE mark to a real-time PCR (polymerase chain reaction) test for detection of a variant in the KIF6 gene, allowing the test to be marketed in the European Union and other geographic areas that recognize the CE Mark. In September 2010, Celera and Abbott signed an exclusive distribution agreement allowing Abbott to market and distribute Celera's CE-marked KIF6 diagnostic test for use on the CE-marked m2000 system in the European Union, other geographic areas that recognize the CE mark, and elsewhere worldwide, excluding the U.S.
Research on KIF6
The association between KIF6 and event reduction during pravastatin (Pravachol®) therapy has been demonstrated in three prospective, placebo-controlled randomized clinical trials of statin therapy for the prevention of CHD events: the secondary prevention Cholesterol and Recurrent Events (CARE) study; the primary prevention West of Scotland Coronary Prevention Study (WOSCOPS); and the PROspective Study of Pravastatin in the Elderly at Risk (PROSPER) study. Additionally, a genetic study of PROVE IT?TIMI 22 reported that in patients who experienced an acute coronary syndrome (ACS), high-dose atorvastatin (Lipitor®), compared with standard dose pravastatin, was significantly more effective at reducing CHD events in KIF6 carriers than in noncarriers. To date, a differential benefit of statin therapy for KIF6 carriers versus noncarriers has only been reported for atorvastatin and pravastatin therapy.
The KIF6 gene variant has also been reported to be associated with increased risk of CHD in prospective population cohort studies. This gene variant was associated with increased risk of CHD in Caucasian and African American participants of the Atherosclerosis Risk in Communities (ARIC) study of 13,907 middle aged Americans, and with increased risk for myocardial infarction (MI) in both the Cardiovascular Health Study of 4,522 Americans, aged 65 or older, and the Women's Health Study of 25,283 women older than 45 years and without a previous history of CHD.
The increased risk of CHD events observed in KIF6 carriers has been shown to be independent of other well-known CHD risk factors, including smoking, hypertension, cholesterol level, age, and sex.
Celera is a healthcare business delivering personalized disease management through a combination of products and services incorporating proprietary discoveries. Berkeley HeartLab, a subsidiary of Celera, offers services to predict cardiovascular disease risk and improve patient management. Celera also commercializes a wide range of molecular diagnostic products through Abbott and has licensed other relevant diagnostic technologies developed to provide personalized disease management in cancer and liver diseases. Information about Celera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.celera.com.
Copyright© 2011 Celera Corporation. All Rights Reserved. Celera is a registered trademark of Celera Corporation or its subsidiaries in the U.S. and/or certain other countries.
Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "plan," and "could," among others. These forward-looking statements are based on Celera Corporation's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Celera notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to: (1) the risks that Celera may not receive required regulatory approvals to commercialize a diagnostic product for KIF6; (2) Celera is using novel and unproven methods to discover markers for the development of new diagnostic products, which may not be successful; (3) Celera's scientific discoveries may not be replicated in studies by other investigators, which may negatively impact the acceptance of, or reimbursement for, its diagnostic products; (4) the diagnostic industry is very competitive, and new diagnostic products may not be accepted and adopted by the market; (5) demand for diagnostic products may be adversely affected if users of these products cannot receive adequate reimbursement for these products from third party payors such as private insurance companies and government insurance plans; (6) potential product liability or other claims against Celera as a result of the testing or use of its products; and (7) uncertainty of the availability to Celera of intellectual property protection, limitations on its ability to protect trade secrets, the risk to it of infringement claims, and the possibility that it may need to license intellectual property from third parties to avoid or settle such claims. The foregoing list sets forth some, but not all, of the factors that could affect Celera's ability to achieve results described in any forward-looking statements. For additional information about the risks and uncertainties that Celera faces and a discussion of its financial statements and footnotes, see documents filed by Celera with the SEC, including its Annual Report on Form 10-K and all subsequent periodic reports. All information in this press release is as of the date of the release, and Celera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
David Speechly, Ph.D.
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