After three decades in immunodiagnostics, DPC has emerged as an industry leader with a menu that offers the largest automated assay selection of any independent manufacturer worldwide, including some highly unique products and state-of-the-art instrumentation and software. Advances in automation, facility expansions and worldwide sales growth have dramatically altered the face of DPC, but the essence of the Company has remained unchanged. Its core values of quality and commitment to customers have withstood the test of time and are a reflection of what DPC truly stands for.

DPC’s formative years
In 1971, DPC was little more than a high-risk business opportunity operating out of a chemist’s home, until Dr. Sigi Ziering happened on it. Dr. Ziering, a hard-working entrepreneur with a Ph.D. in theoretical physics, became an investor and partner in the business and moved it into a small factory in Los Angeles. At the very beginning, DPC had only one diagnostic kit—a tritiated RIA for cyclic AMP, which was primarily of research interest.

DPC’s menu of high-quality, convenient Coat-A-Count RIAs expanded rapidly. By the 1980s, many Coat-A-Count assays had become market leaders.

As DPC focused its efforts on clinical kits for hospitals and reference labs, independent entrepreneurs overseas initiated distribution agreements with DPC, fueling sales in Europe. By concentrating on quality, service and fair market pricing, DPC found success as a niche player within a competitive arena consisting, at the time, of two large, mainstream manufacturers and many smaller entities, most of which eventually disappeared through mergers and acquisitions. DPC’s management emphasized the maintenance of tight controls over quality and cost from raw materials to finished products, affording DPC a high degree of self-sufficiency within the industry.

DPC pioneered a number of technological advances including a proprietary technique for coating tubes that allowed routine attachment of a wide range of antibodies. This technology was incorporated into such lines as Coat-A-Count^® and Coat-A-Count^® IRMA. The Company also developed a highly efficient infrastructure for product development and production, bringing new assays to market extremely quickly and enabling rapid menu expansion. As a result, by the 1980s, DPC was offering an extensive array of high-quality, state-of-the-art RIAs worldwide, many being market leaders such as DPC’s reproductive hormone assays.

With the introduction of the IMMULITE chemiluminescent immunoassay system in the early 1990s, DPC offered fully automated, random access, nonisotopic testing.

The automation breakthrough
In 1992, DPC’s business expanded to include a highly competitive automated- immunoassay system, through the acquisition of Cirrus Diagnostics, Inc.
The new IMMULITE^® technology, with
its proprietary wash technique, offered efficiency, reliability and low labor costs. Although DPC continues to maintain its line of classic RIA kits, the acquisition represented a major realignment of the company’s basic technology to include full automation in nonisotopic, random access immunoassay testing. DPC launched IMMULITE in 1993. By the following year, IMMULITE was already accounting for 20 percent of DPC’s business and featuring the most complete spectrum of thyroid, fertility and cancer tests and panels for allergen screening of any automated immunoassay system available. An enhanced version of the system, arriving in the form of the IMMULITE^® 2000, was introduced in 1998, and opened the door for DPC to enter the high-volume US market.

Current outlook
Today, with nearly 500,000 square feet of research, manufacturing and administrative facilities worldwide, DPC’s vast product portfolio continues to grow at a rate unsurpassed by any of its competitors. Dedicated to furthering its offerings and advancing system automation, DPC utilizes more than ten percent of its annual revenues for research and development in the areas of biochemistry, molecular biology, software and instrumentation. Many of the Company’s specialized scientific departments are engaged in discovery-phase projects, aimed at finding new diagnostic markers of medical significance.

In keeping with its reputation for being unique, DPC has set itself apart from its competitors with several notable product offerings, such as the industry’s first full menu of assays for cardiac biomarkers, including the first homocysteine assay for use on a true random access automated analyzer, and an exclusive line of cytokine* and inflammation marker assays. DPC also continues to maintain the highest quality standards and is the first and, currently, the only company to receive CE Mark approval for hepatitis B, Toxoplasma, rubella and cytomegalovirus assays.

The IMMULITE and IMMULITE 2000 products now comprise approximately 80 percent of DPC’s total business. Even in its ninth year of production, the broad menu and small footprint of the original IMMULITE have maintained a continuing worldwide demand for this reliable, user-friendly system. IMMULITE Turbo software provides the emergency room and surgical units with high-speed results for intact PTH, HCG and cardiac biomarkers. Meanwhile, the high-throughput IMMULITE 2000 is meeting the needs of high- volume facilities, which compose a very important segment of the US market, and has effectively doubled the rate of DPC’s sales growth in the US compared to overseas, where growth has always been strong. In an effort to improve the preanalytical phase of laboratory testing, DPC has recently developed the IMMULITE 2000 Sample Management System, an optional peripheral that provides a universal track interface and improved productivity through STAT capability and no-pause bulk sample loading of up to 200 samples at a time.

Despite the emphasis on IMMULITE products and automation, DPC continues to offer isotopic counterparts of many IMMULITE assays to address the needs of smaller, low-volume facilities throughout the world and to provide flexibility in settings requiring assay customization. In addition, DPC supplies conventional allergy kits including the AlaBLOT^† immunoblotting system for positively identifying specific allergen components. DPC also offers I. D. Blot* immunoblotting kits for the identification of specific infectious disease antibodies to complement serodiagnostic screening assays.

Keeping up with the trends
DPC has noted the trends in patient and clinician perceptions of in vitro diagnostics (IVD)—trends that have resulted in a more central role for clinical laboratories within the healthcare delivery system. While IVD was previously viewed as making only a modest contribution to diagnosis and therapeutic monitoring, its use has expanded to include preventative medicine through risk assessment and a far more extensive role in treatment determination, therapeutic monitoring and results evaluation. Recognized as a cost-effective and objective aid for diagnosis and patient management, clinicians are increasingly reliant on IVD for critical details. Certain assays, such as Third Generation PSA, are also in demand by patients, who are now more educated and proactive about their own healthcare.

In support of the industry’s changing needs, DPC continues to bring new cutting-edge assays to market at a remarkable pace through the expertise of its vertically integrated R&D team, and by forming business relationships with product patent holders such as Quidel for the Pyrilinks^®-D assay, used in osteoporosis risk determination and monitoring. DPC’s list of affiliations is growing each year through increasing numbers of negotiated contracts with group purchasing organizations (GPOs), providing greater product accessibility to GPO buyers.

DPC also provides comprehensive literature on its Web site and educational CDs as a service to patients and clinical healthcare providers alike. In addition, the Company takes great pride in having a reputation for developing comprehensive reference range data from studies based on IMMULITE and IMMULITE 2000 assays—works that represent a collaboration between DPC, its customers and clinical experts.

The IMMULITE 2000 Allergen Wedge, holding up to six different liquid allergens, is a key component of DPC’s technological breakthrough in allergy testing.

Poised for the future
With an eye to the future, DPC strives to continually improve its ability to meet the needs of the medical community through state-of-the-art immunodiagnostic systems and an ever-broadening menu. The Company takes pride in being a mainstream manufacturer of a full spectrum of routine, high-volume test kits, and also in its development of many novel and relatively specialized products such as assays for cytokines and anti-TPO. DPC continues to uphold its commitment to world-class service, support and quality—hallmarks of DPC’s customer pledge. Recognizing that accurate test results are often only one facet of the diagnostic work-up, DPC is dedicated to providing a full solution for results interpretation and assessment including I. D. Blot* test kits and innovative software such as FOLLOW, which tracks cancer marker results over time.

Having already developed complete automated routine assay line-ups for thyroid, anemia, tumor markers and reproductive endocrinology, DPC is in the midst of a product roll-out for the newly released IMMULITE 2000 3gAllergy, the first fully automated random access method for allergen-specific IgE determinations. Allergy testing no longer requires choosing between a specialized workstation and outsourcing. Now allergy testing can be conducted in-house just like any other routine immunoassay, at the same time and on the same instrument. With the advantages of automated allergy testing, such as workstation consolidation, DPC expects to significantly increase its presence in the allergy market and to radically alter the way such testing is conducted.

Infectious disease is also drawing attention as DPC looks forward to having one of the broadest infectious disease menus outside the US by early 2002.

Other new and important developments on the horizon include an automated ANA assay (the industry’s first) for autoimmune screening with accompanying ANA Line Blot™ tests for specific follow-up, and DPC’s recently released automated routine therapeutic drug monitoring (TDM) panel.

Dr. Sigi Ziering, a man whose vision became a reality.

DPC’s spirit remains unchanged
Through continued growth and expansion, DPC will always stand apart in its dedication to customers and to the immunodiagnostics market. We can thank Dr. Ziering for having laid such a solid foundation during DPC’s formative years. The philosophy and values he fostered became an integral part of DPC’s corporate fabric long ago, and Dr. Ziering’s influence remains with us to this day.

* Currently available outside the US only

^† Sold as analyte-specific reagents in the US