ALAMEDA, Calif.--(BUSINESS WIRE)--Celera Corporation (NASDAQ:CRA - News) today announced that it has 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.
KIF6 encodes a kinesin, a member of a family of proteins involved in microtubule-mediated intracellular transport. Previous research has shown that a variant of the KIF6 gene is associated with up to a 55% increased risk of primary and recurrent coronary heart disease (CHD) events in the placebo arms of pravastatin clinical trials, and that this increased risk was significantly reduced with statin therapy.
“The application of the CE mark to our KIF6 test represents a significant milestone for Celera, allowing commercialization of the first in vitro diagnostic genetic product to predict risk for coronary heart disease and response to statin therapy. We also expect to submit a KIF6 test for pre-market approval to the Food and Drug Administration later this year as we continue to move our pipeline of proprietary genetic tests into routine clinical practice,” said Kathy Ordoñez, Chief Executive Officer of Celera.
Research supporting KIF6
The association between KIF6 and event reduction during pravastatin (Pravachol®) therapy has been demonstrated previously in three prospective, placebo-controlled randomized clinical trials on 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, the benefits of statin therapy for KIF6 carriers has only been demonstrated with atorvastatin and pravastatin therapy.
The KIF6 gene variant has also been reported to predict risk of CHD in prospective population genetic 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 (a study of 13,907 middle aged Americans), and with increased risk for myocardial infarction (MI) in both the Cardiovascular Health Study (a study of 4,522 Americans, aged 65 or older), and the Women’s Health Study (a study of 25,283 women older than 45 years without a previous history of CHD). Thus, this KIF6 gene variant has been investigated in studies that included a total of approximately 55,000 people.
In a case-control analysis of subjects in the Ottawa Heart Study, no association was found between KIF6 and >50% coronary artery narrowing, which is a different clinical endpoint than the acute CHD event end point examined in the other KIF6 studies referenced above. Furthermore, 89% of the cases in the Ottawa Study were on statin therapy, which Celera believes may have suppressed the increased risk of KIF6 carriers.
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, further supporting the conclusion that the KIF6 gene variant is an independent predictor of risk for CHD. Recently, the KIF6 protein was also shown to be expressed in atherosclerotic lesions in both mouse and human coronary arteries but not in normal arteries.
Celera is a healthcare business focusing on the integration of genetic testing into routine clinical care 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. 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.
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 "expect," 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 in the United States and other jurisdictions; (2) Celera is using novel and unproven methods to discover markers for the development of new diagnostic products, which may not be successful; (3) the diagnostic industry is very competitive, and new diagnostic products may not be accepted and adopted by the market; (4) 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; (5) potential product liability or other claims against Celera as a result of the testing or use of its products; and (6) 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.
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David Speechly, Ph.D., 510-749-1853