Diagnostic Systems Laboratories Inc (DSL) is a primary manufacturer of a wide range of specialized immunodiagnostic assays. Recently, Clinical Lab Products talked to Rusty Nicar, PhD, technical director for DSL, about the company’s position in the marketplace, the challenges the company faces, and its vision for the future.

CLP: Please give some background on your company.

Nicar: DSL is a privately owned company founded in 1981; it currently has 150 employees. Company headquarters are located in the Clear Lake area south of Houston. The headquarters site is set on several acres and houses DSL’s corporate offices, primary R&D, manufacturing, and DSL’s global marketing and technical services. In addition, DSL has subsidiaries in the UK, France, Germany, Italy, the Netherlands, Australia, and India, as well as an R&D laboratory in Toronto. DSL products are sold in over 70 countries through an extensive network of international distributors and affiliates.

The company offers over 190 products for androgen assessment, fertility and reproductive function, mineral and salt balance, bone and mineral metabolism, growth factors, metabolism, disease markers, thyroid function, and serology. To complement this range of immunoassay products, DSL also offers over 380 research reagents, which include peptides and/or specific antibodies for inhibins, leptins, orexins, ghrelin, and the various members of the GH-IGF-IGFBP axis.

A CLIA-certified reference laboratory is also located at DSL’s headquarters, with satellite laboratories located in Oxford, London, and Toronto. The reference laboratory at headquarters offers an extensive endocrine test menu, including DSL’s range of growth factor, steroid hormone, and inhibin assays. Clinical-trial services are provided primarily to the biotech and pharmaceutical industries, and contract research services are also provided to institutions such as NIH and other leading academic centers. Additional services provided include custom assay development and an assay-proficiency service.

CLP: What differentiates DSL from its competitors?

Nicar: The quality of DSL’s products and services, its philosophy, and its ongoing support of medical science differentiate DSL from its competitors.

DSL is the original manufacturer of a comprehensive range of immunoassays. The company offers assays in both isotopic and nonisotopic formats. DSL has the most comprehensive range of androgen and estrogen assays, and it is the established world-market leader for several steroid assays, including androstenedione, androstanediol glucuronide, estrone, and DHEA. DSL’s assays are invariably direct assays that allow analysis of patient samples without pretreatment.

For over 20 years, DSL has worked with many notable scientists and clinicians in the study of the GH-IGF-IGFBP axis, and we now offer immunoassays and reagents for most members of this axis. DSL is the recognized market leader for IGFBP-3 and has a considerable market share for IGF-I.

Recently, DSL became the exclusive supplier of an exciting new range of inhibin and activin immunoassays and products for fertility and reproductive endocrine applications. Potential applications include prenatal screening, male infertility, IVF applications, perimenopausal transition and ovarian reserve, pubertal development, ambiguous gender, and ovarian tumors.

DSL has been directed by Gopal Savjani, president and CEO, since the company’s inception. DSL’s management structure allows the company to respond promptly to market demands, giving us an edge on those competitor’s whose corporate structures may dictate more laborious and complex decision-making processes.

DSL offers funding and support each year for scientists and clinicians during early and late research stages for numerous potential disease biomarkers. We also provide considerable financial support for a number of scientific conferences.

Unlike many medical diagnostic companies, DSL supports the development of immunoassays of many important biomarkers that may be overlooked or rejected by other companies due to relatively low market demand. Moreover, instead of simply supporting proven established markers, DSL supports the development of tests that are still in the early stages of clinical validation and market acceptance. We have a flexible R&D and production program to enable the development of lower-volume or early-stage tests.

CLP: What is DSL’s competitive advantage?

Nicar: DSL’s innovation, its extensive endocrine product range of isotopic and nonisotopic immunoassays, and the quality and range of services offered to customers give DSL a major competitive advantage.

Many endocrine tests that are now considered routine and worthy of random access automation were developed in companies such as DSL. IGFBP-3 and Inhibin A illustrate DSL’s commitment to the advancement of diagnostics. DSL produced the first commercial assay for IGFBP-3 in the 1980s and has actively supported research groups around the world in the application of this marker in the diagnosis and monitoring of various growth disorders. After some 20 years, this test is now considered a valuable routine test and has attracted the attention of manufacturers of random-access platforms.

The inhibin and activin family of products represent another area where DSL has started to bring tests to the market that have been previously unavailable in clinical laboratory settings. For example, Inhibin A was largely considered a highly laborious test (due to the fact that every sample had to be boiled prior to assay) and was offered only by two or three laboratories in the world. In 2000, DSL developed a new convenient version of this test that did not require any sample pretreatment and was fully validated for clinical use. As a result, the Inhibin A test has been transformed from an esoteric research tool to an established clinical diagnostic test in reproductive medicine. Subsequently, the test is now offered by every major reference and clinical laboratory in the country and recognized by OB/Gyns as the standard of care.

DSL’s product range can be adapted to run on open automated platforms but also can be run manually. In addition, DSL has continued to supply its isotopic range of products despite the increased burden of regulatory permits, regulatory requirements and costs associated with this range. Unlike many competitors that have either dropped or decreased the number of isotopic products, DSL plans to continue the supply of these products in recognition of market need and DSL’s inherent flexibility and usefulness in several clinical and research applications.

Finally, our technical services team is comprised of several members, each of whom have over 15 years of experience either in clinical or research laboratory management. Furthermore, each of them have been former users of DSL products in their respective laboratories. It’s a concept we call “customers helping customers.” This experienced team is able to offer assistance on a variety of issues including, among other things, product performance, species cross-reactivity, or the modification of existing products for saliva or blood-spot analysis for research applications.

CLP: As a manufacturer of specialized immunoassays, what are some of the challenges you face?

Nicar: Reimbursement for tests is a major challenge faced by our customers and this challenge impacts DSL. For an initial period of time following the introduction of a new test, the cost of the test may be borne in part by DSL, the customer, and the patient. Hospital and clinical laboratories depend on managed care and HMO payments for their cost recovery. With the trend toward reduced payments for patient care, DSL must work with each customer concerned to ensure that the testing service is maintained and the standard of care maintained.

Secondly, laboratories are under increasing pressure to offer an increasing menu of tests while reducing overall costs. Manufacturers and customers alike are affected by this market pressure, and DSL is committed to supplying cost-effective solutions without sacrificing quality. We are also committed to developing new systems, which will give customers the convenience of random access with the expected DSL quality.

Thirdly, regulatory issues continue to be a challenge for all. DSL is compliant with all key regulatory requirements, including cGMP and ISO, In addition, DSL products are also certified to meet the new CE regulations in Europe.

CLP: Where do you see your company in the next 5 years?

Nicar: DSL will continue its steady growth over the next 5 years and will consistently offer a superior range of immunoassay products and services. In addition to the development of a new random access system, it is expected that the company will develop an increased number of reliable salivary assays and blood-spot assays, given the increasing market demand. DSL also plans to develop a full range of assays for numerous animal species for animal research and veterinary applications. It is expected that the demand for DSL’s reference laboratory will increase, along with its proficiency testing capabilities.