Biotech Values

[mcbio]

CRA's counterpunch

[Here's CRA's counterpunch FWIW. It will be interesting to see the impact on the stock on Friday.]

http://finance.yahoo.com/news/Celera-Says-CaseControl-bw-4098489287.html?x=0&.v=1

Celera Says Case-Control Publication on KIF6 Does Not Refute Prior Research on KIF6’s Association with Coronary Heart Disease and Statin Benefit
Findings Also Show No Significant Difference from Earlier Published Reports by Celera and Others on Case-Control Studies of KIF6

ALAMEDA, Calif.--(BUSINESS WIRE)-- Celera Corporation (NASDAQ:CRA - News) today noted that the case-control studies describing a lack of association between KIF6 and coronary artery disease (CAD) published in the Journal of the American College of Cardiology did not investigate the association between KIF6 and statin benefit and the results are subject to fundamental biases that limit any comparison to the previous prospective studies that found an association between KIF6 and coronary heart disease (CHD).

“We believe that the case-control study of coronary artery disease published by Assimes et al., is not a replication study of the published prospective studies of KIF6 Trp719Arg, which involved rigorous prospective and randomized controlled trial designs,” said Thomas White, Ph.D., Chief Scientific Officer at Celera. ”Moreover, Celera and others have previously reported1-4 the finding that in case-control studies there was no association between KIF6 and nonfatal MI or CAD, and thus we see little that is new or relevant to the association between KIF6 and statin benefit.”

Genetic studies of four randomized controlled clinical trials (CARE, WOSCOPS, PROVE IT, and PROSPER) found that statin treatment significantly reduced CHD events in carriers of the KIF6 variant. Celera notes that the investigators of these latest case-control studies speculate that statin use was not common enough to have suppressed an association between the KIF6 variant and CAD in the case-control studies. However, if KIF6 carriers taking statins had benefited from therapy, they would not have been included among the CAD cases in these studies – thereby reducing the possibility of finding an association between KIF6 and risk for CAD. Simply put, the prevalence of statin use was not reliably known by the authors of the case-control studies - unlike in the rigorously controlled randomized trials cited above in which the KIF6 variant was studied. Indeed, the Assimes et al., paper even notes the lack of robust awareness of traditional risk factors in the case-control studies. Similarly, other reports have convincingly demonstrated that case-control studies of the association of hypertension with risk “are seriously compromised when the trait is subject to the effects of anti-hypertensive treatment5.”

“We believe this case-control publication mischaracterizes the prior peer-reviewed papers on KIF6’s association with CHD. To ascribe more credence to results from case-control studies, with their long history of known selection biases than to results from prospective cohort studies and prospective, placebo-controlled, randomized clinical trials, runs counter to the accepted hierarchy of medical evidence. Additionally, 70% of the CAD samples used in the Assimes et al., case-control study publication and multiple co-authors of the paper are employed by a commercial firm that sells a competing genetic test for CHD risk,” added Dr. White.

The accompanying editorial, which contains numerous inaccuracies, misstatements and omissions, wrongly asserts that the prior KIF6 results “stems primarily from a few observational studies” and inaccurately states that the reports of CHD event reduction from statin therapy in KIF6 carriers are “largely unsubstantiated”. In fact, a combined analysis of 7 large prospective studies has demonstrated the association between KIF6 and CHD risk6. Further, the association between KIF6 and statin benefit was established in genetic studies of four randomized, controlled clinical trials (CARE, WOSCOPS, PROVE IT, and PROSPER) in which statin therapy was found to reduce CHD events in carriers of the KIF6 variant. Thus, the KIF6 gene variant has been investigated in studies that included a total of approximately 55,000 people. The statistical analyses reported for five of these studies were conducted by external academic groups.

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 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. A published abstract suggests that noncarriers may benefit from simvastatin therapy.

The KIF6 gene variant has also been reported to predict 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, further supporting the conclusion that the KIF6 gene variant is an independent predictor of risk for CHD. In a presentation at the 2010 Arteriosclerosis, Thrombosis, and Vascular Biology meeting of the American Heart Association, the KIF6 protein was also reported to be expressed in atherosclerotic lesions in both mouse and human arteries but not in normal arteries, adding supporting biological information to the genetic results.

About Celera

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.