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Start-Ups - Berkeley HeartLab, Inc.

Personalizing Cardiovascular Medicine

Public awareness of heart disease is steadily increasing. "Cholesterol" has become a layman's term–hailed as the ultimate evil–with few comprehending its true implications. In fact, of individuals suffering from coronary artery disease, an overwhelming 80% have normal cholesterol levels. Berkeley HeartLab, Inc. (BHL) holds an exclusive license to procedures that elucidate crucial details about blood cholesterol fractions. Working in conjunction with personal physicians, Berkeley HeartLab provides thorough and accurate assessments of cardiovascular health and personalized treatment plans that provide long-term monitoring of patient progress.

More Than a Diagnostic

In 1978, Dr. Ronald Krauss of the Life Sciences Division at Lawrence Berkeley National Laboratory began researching cholesterol fractions and the cardiovascular risks associated with these subtypes of low density lipoprotein (LDL) and high density lipoprotein (HDL). Over twenty years later, in 1999, Krauss was issued a patent for his work with cholesterol subclasses. This patented technology currently serves as one of many diagnostics utilized by BHL. Krauss' LDL-S₃GGE™; and HDL-S₃GGE™; tests, developed at Lawrence Berkeley National Lab, are the only methods available to analyze LDL and HDL distribution across all scientifically known subclasses.

Lipoproteins carry cholesterol through the bloodstream. Since cholesterol is a fatty substance and blood is watery, mixing cholesterol and blood is similar to combining oil and water–the two substances simply do not mix. To allow cholesterol to travel through the blood, cholesterol is combined with a protein after it is generated in the liver–resulting in a fat and protein combination known as a lipoprotein. These lipoprotein packages carry the cholesterol, with each type of lipoprotein having a unique role in heart disease risk. The aforementioned LDL and HDL are just two kinds of lipoproteins. LDL is the primary carrier of cholesterol through plasma, and is considered to be "bad cholesterol." A high LDL level is a positive risk factor for heart disease and atherosclerosis. High density lipoprotein, or HDL, is the so-called "good cholesterol." Raising the HDL to LDL ratio has been shown to substantially lessen the risk of cardiovascular disease.

LDL-S3GGE™ is the most accurate separation of low density lipoproteins (LDL). LDL cholesterol is the "bad" type of cholesterol that can block arteries.

Traditional blood lipoprotein analysis measures the levels of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Using the technology pioneered by Krauss, Berkeley HeartLab breaks LDL and HDL into seven and five distinct categories, respectively. Frank Ruderman, the company's Chairman and CEO, says that Berkeley HeartLab has the "most discriminating technology for breaking LDL and HDL into subclasses." Specific risks have been associated with each of these individual subclasses, allowing BHL to paint an extremely thorough and comprehensive picture of cardiovascular health.

These lipoprotein measurements by no means stand alone in Berkeley HeartLab's testing procedures. However, the lipid analysis developed at Berkeley Lab is what Ruderman considers to be the company's "raison d'être." Though it may represent the fundamental core of the HeartLab's technology, inflammation, clotting, genetics, inflammatory response, and a variety of other factors are also addressed. When speaking of BHL, Ruderman is quick to mention that the company "provides more than a diagnostic or an assessment." He states that "Berkeley HeartLab participates in advanced cardiovascular informatics." For each patienteach patient, BHL examines all "causative agents" in heart disease risk and provides personalized treatment programs including medication, diet, and exercise that are monitored over time.

Combating All Odds

Initially, Krauss says that he "never thought of the technology in terms of its commercial value." Krauss' tests were originally used in a clinic affiliated with Sequoia Hospital, located in Redwood City, California. In 1996, these efforts led to the founding of Berkeley HeartLab in San Mateo–contrary to the location suggested by its name. Today, BHL has moved to Burlingame and has a laboratory facility that operates out of Alameda.

In this startup's early days, a major obstacle stood in its path: lipid subclasses comprised the linchpin of BHL's testing, but the cardiology specialty had little knowledge about the significance of these subclasses. Clinicians needed to understand and embrace Berkeley Heart Lab’s analysis. In order to meet this challenge, Ruderman says thatsays, "BHL spent millions of dollars to educate cardiology specialists." Once the importance of these subclasses was recognized, the HeartLab and its revolutionary diagnostics gained respect throughout the medical field.

LDL-S3GGE™Subclass Distribution.There are seven scientifically known LDL cholesterol subclasses, known as LDL I, IIa, IIb, IIIa, IIIb, IVa, and IVb. The subclasses of IIIa, IIIb, and IVb are made up of smaller, more dense particles (shaded) are more closely related to heart disease.

To date, Berkeley HeartLab has achieved an impressive level of success. Its seventy-three employees are split approximately evenly between the company headquarters and the laboratory site. Ruderman states that the company is "growing in excess of 50% each year." Dr. Krauss credits BHL's success to a "combination of the technology's value and the ability to package it in a marketable way to clinicians."

Making a Difference

Cardiovascular disease is the primary cause of death among American adults. It kills one person a minute within the United States.. Every twenty-nine seconds, an American suffers from a coronary event. Berkeley HeartLab specifically targets what Ruderman terms as "symptomatics," people who have a history of cardiovascular problems. Here in the U.S., these individuals comprise a significant portion of the adult population, including approximately nineteen million individuals who could benefit from BHL diagnostics.

The June 2001 issue of Men's Health tells an equally impressive story. David Rubinson, a record producer for such big-name stars as Carlos Santana, had undergone two coronary bypass operations, even after following treatments prescribed by physicians. Standard testing revealed little; Rubinson's lipid profile was within the normal range. Berkeley HeartLab diagnostics uncovered irregularities which conventional testing could not detect. With BHL's help, Rubinson is now able to exercise control over his cardiovascular condition. In a particularly memorable quote, the producer states "When I talk about Superko [BHL's Medical Director], tears come to my eyes…Without this man, I'm gone."

Revolutionizing the Field

Ruderman describes Berkeley HeartLab's "founding dream" as "improving cardiovascular treatment plans by providing a more personalized approach." BHL's many satisfied patients will affirm that this dream has been achieved. With the recent surge of positive publicity, more and more patients are becoming interested in Berkeley HeartLab. Insurance companies are also recognizing the value of BHL tests and treatments; Medicare reimburses 30% of the cost, PPOs reimburse from 80-90%, and contracts have been established with several HMOs.

At the moment, their doctors refer the majority of BHL patients. Nationwide, approximately 1000 doctors work with Berkeley HeartLab, primarily in the states of Florida, Texas, and California. These three states currently generate most of BHL's revenue, as part of the company's regional rollout plan. The corporation is actively raising funds to move beyond this triad of locations and into other areas of the United States.

In addition to expanding the regions that are served, Berkeley HeartLab is also increasing its research efforts on the correlation between genomics and cardiovascular risk. In conjunction with Roche, Ruderman states that BHL is examining the links "between gene, phenotype, and physical outcome," hoping to further "tailor treatment by looking at phenotypic subsets and genomic correlation." These studies have the potential to significantly impact the medical field and improve the lives of many.

Berkeley HeartLab is revolutionizing the treatment of cardiovascular disorders. As the business grows, BHL's impact can only increase. We have high hopes that the HeartLab's personalized treatment will soon become the norm in the field of cardiovascular medicine.