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is our interactive website that offers heart health resources, opportunities to interact with a Berkeley HeartLab Clinical Educator, test results, and tools to record and track progress toward patients' goals.
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The Evolution of Advanced Cardiovascular Testing
1950-1960
- John Gofman, MD, Ph.D and colleagues at the Lawrence Berkeley National Laboratory (LBNL) used the analytical ultracentrifugation (AnUC) technique to discover that lipoproteins float at different levels depending on their density.
- The classification of VLDL, IDL, LDL, and HDL and the subclasses within those lipoproteins soon followed.
- Gofman et al. analyzed blood samples from the Framingham and Lawrence Livermore study and found that lipoprotein subclasses beyond LDL-C and HDL-C had a significant relationship to coronary artery disease (CAD).
1960-1980
- The work done in prior decades by Gofman and his associates was intriguing, but AnUC was not practical for routine clinical use and high volume throughput. Thus began the quest at Lawrence Berkeley to develop a commercially viable method for analyzing subclasses that correlated with AnUC.
1980-1993
- A first generation linear gel was developed. It correlated to peak particle diameter, but not to phenotype patterns or AnUC defined subclasses.
1993-1999
- A second generation gradient gel was developed. It correlated to phenotype patterns (A, B, and I), but not to Analytical Ultracentrifuge (AnUC) defined subclasses.
- In 1996, Berkeley HeartLab, Inc. was founded. The company provided esoteric cardiovascular testing services for secondary prevention patients.
- Berkeley HeartLab signed an exclusive license agreement for the segmented gradient gel technology with LBNL.
- A third generation segmented gradient gel (S-GGETM) was developed. It correlated to the AnUC defined subclasses and was named LDL-S3GGE® and HDL S10GGE®. This technology was commercialized by Berkeley HeartLab, Inc.
2000-2005
- Berkeley HeartLab developed a proprietary method for performing a quantitative and highly accurate determination of lipoprotein subclasses.
- Berkeley HeartLab created a comprehensive menu of advanced cardiovascular tests (including apoB Ultra, Lp(a), apoE, and many more) and a web delivery system that provided clinically integrated lipoprotein subclass results to clinicians and patients.
- In 2002, Berkeley HeartLab launched a therapeutic compliance support program (the 4myheart Program) to support medication and lifestyle modification adherence through personalized patient touchpoints.
2005-2007
- Berkeley HeartLab refined its comprehensive risk assessment profile and added markers associated with atherosclerotic disease progression and myocardial stress (LpPLA2, nt-proBNP and more), further enabling insight into personalized disease management.
- Eight 4myheart Centers for cardiovascular disease management were opened throughout the US that anchored the expanding 4myheart Program for disease management.
- In October, 2007, Celera Corporation acquired Berkeley HeartLab. Celera is a healthcare company delivering personalized disease management through a combination of products and services incorporating proprietary discoveries. For more information about Celera, visit www.celera.com.
2008
- In January, 2008, Celera published papers in JACC demonstrating that carriers of a variant of the KIF6 gene are at elevated risk of Coronary Heart Disease (CHD) and that this incremental risk can be significantly reduced by statin therapy*.
- Berkeley HeartLab commercialized KIF6, its first pharmacogenomic test characterizing cardiovascular disease (CVD) risk and the magnitude of therapeutic benefit.
- Berkeley HeartLab opened eight additional 4myheart Centers to further expand its cardiovascular disease management program.
*To date, the benefit of statin therapy for KIF6 carriers has been demonstrated with atorvastatin and pravastatin therapy.
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