By Lori Sichtermann

 Robert W. Ban, PhD

In 1974, when Robert W. Ban began mixing and stirring in the kitchen, he didn’t produce a cake or a four-course dinner. Instead, he cooked up a globally recognized corporation that supplies more than 40 clinical controls to the laboratory industry.

Based in Redondo Beach, Calif, Quantimetrix Corp was developed by Ban through personal persistence and determination, with no outside financial support from partnerships, venture capitalists, or private sources. Clinical Lab Products recently spoke with Ban, president of Quantimetrix, about the development of the company and the importance of being perceptive about what the market is lacking and possessing the entrepreneurial spirit to satisfy its needs.

CLP: Quantimetrix had a grassroots beginning. Please provide some background on the development of the company.
Prior to forming the company, I had worked in several clinical laboratories as a clinical chemist and was aware of a need for new diagnostic products. I came across an article describing the development of a new reagent using the dye coomassie blue for the detection of low concentrations of protein. Since there was a need to increase the sensitivity of methods for detecting low concentrations of protein in biological fluids, such as urine or spinal fluid, I formulated the reagent and sold it to hospitals and reference laboratories throughout the United States by telephone. I was approached by several laboratories to consider making other products, such as controls. The coomassie blue dye turned out to be too sensitive, and was subsequently modified and replaced by the dye pyrogallol red.

Back then, control materials for the clinical lab were supplied in lyophilized form. Since I had no money to purchase a lyophilizer, I decided to produce the controls in liquid rather than in dry form. As a result, I became a pioneer in supplying the market with liquid stable clinical controls. The advantage of these controls was uniformity. Each bottle contained the same concentration of analytes because they were formulated from a large pool and did not have to be individually reconstituted using varying amounts of water delivered from a pipette. I supplemented the controls with certain stabilizers, which caused the control products to become more stable, affecting stability for years, instead of months. As a result, the controls became more reliable, convenient, and cost effective for use in the clinical laboratory.

CLP: Tell us more about the types of products the company offers to the industry.
Quantimetrix has successfully launched more than 40 medical products in its 30-year history. It currently has many different types of clinical controls using different biological fluids, such as urine, serum, spinal fluid, and sweat. I believe as more tests are developed for new and different analytes the need for controls will continue to increase and proliferate.

CLP: What needs does the company satisfy within the clinical laboratory market?
The need for controls will always be necessary for the accurate testing operation of a clinical laboratory. Not only are they mandatory for accurate monitoring of clinical laboratory testing but they are required by the FDA and other laboratory professionals. Clinical controls assure the accuracy and reliability of testing procedures and provide added assurance to the diagnosing physician and ultimately the patient that the diagnosis is reliable.

CLP: Specifically, what is the Lipoprint cholesterol test offered by Quantimetrix?
Several years after developing liquid stable quality control products, I came upon a company that was developing a procedure to measure different forms of cholesterol. I was so impressed by this methodology that I visited the company and learned that they were interested in divesting the company’s division. As stated before, funding in the beginning stages of the company was difficult, so I borrowed $75,000 from my mother (which I paid back long ago), and purchased the division. Many years later, and after much research and refinement, the testing procedure was released by Quantimetrix.

The methodology was termed Lipoprint because it provides a lipoprotein printout of the serum lipoprotein subspecies distribution in graphical form, which can easily be interpreted by the physician. The Lipoprint test methodology is currently the only one to be cleared by the FDA for the investigation of lipoprotein abnormalities. The lipoprotein subspecies profile characterizes the atherogenic lipoprotein phenotype, indicating the risk of developing coronary heart disease.

The Lipoprint assay requires only 25 µL of fasting patient serum and a total analysis time of approximately 2.5 hours for up to 48 samples. The Lipoprint system makes LDL subfraction screening easy and can be performed in any clinical laboratory providing a comprehensive, full-color printout of the patient’s lipoprotein profile.

Most physicians order what is called the “lipid profile” which consists of total cholesterol, triglycerides, LDL, and HDL. But 50% of those patients who have a normal lipoprotein profile die of coronary heart disease. Consequently, the routine lipid profile is insufficient to accurately determine the risk of coronary heart disease. The Lipoprint procedure provides a much more intimate and reliable picture of what is going on at a molecular level, and not only increases the accuracy of diagnosis but also provides a way of more effectively monitoring subsequent treatment.

With the discovery of the LDL receptor and the recognition that both small LDL and large LDL particles have reduced affinity for the LDL receptor and therefore accumulate in the circulation, more interest will be focused on the LDL subspecies. The metabolic pathways of interconversion of the lipoprotein particles from VLDL, IDL, LDL, and HDL are complicated and are still under study and depend on many factors.

In the future, more research also will be directed to ways that can be used to stimulate the increased production of HDL, which is involved in decreasing the influence of LDL particles.

New understanding of the influence and inter-relationship of these lipoprotein particles is emerging. The Lipoprint is a useful tool to investigate the influence of drugs on the production and metabolism of lipoprotein particles and provides a convenient method of studying and monitoring drug therapy.

The atherogenic lipoprotein phenotype can be reversed using increased exercise, alteration of diet, and the use of lipid-lowering drugs. Results can usually be observed within a matter of months.

CLP: Company literature states that the biggest hurdle yet to overcome is the marketing of the Lipoprint test. What strategies does Quantimetrix have to market the test?
The Lipoprint is now being distributed worldwide, but the main focus has been in the United States. Effective marketing of the Lipoprint test depends primarily on the education of the physician who will order a laboratory to perform the test and will explain its significance to the patient and follow up. The Lipoprint test should be repeated periodically to follow the progress of effective therapy.

Strategies that have been relied on to market the test have been the Web, seminars, trade shows, journal advertising, telemarketing, mailers, and direct contacts.

CLP: Does Quantimetrix have any other products to release?
Quantimetrix will soon release a new multi-analyte liquid stable serum control called Liquisure. This control will be available in smaller volumes to be used with large analyzers, which require smaller sample volumes.

CLP: What industry challenges have you faced, and what has the company done to overcome these issues?
New methodologies require time to be accepted by the clinical community. Several years ago one could find little information about the cholesterol subfractions; however, today, there is more information on the significance of the lipoprotein subspecies and their importance in coronary heart disease.

CLP: Where do you see the industry heading?
The clinical industry is heading toward the use of a variety of new methodologies for testing. These new testing methods will be utilized as new biomarkers become available.

CLP: Any final thoughts?
Quantimetrix serves as a reminder that it is possible to develop a company that serves the needs of the clinical laboratory community without financial backing if the entrepreneurial spirit is strong enough. In the years ahead, Quantimetrix will continue to offer new controls and methodologies to serve the increasing need for accuracy and reliability.

Lori Sichtermann is associate editor of Clinical Lab Products.