Genomics Collaborative and Specialty Laboratories Form Agreement to Study Genetic Markers in Large Heterogeneous Populations.

Health/Medical Writers

CAMBRIDGE, Mass. and SANTA MONICA, Calif.--(BW HealthWire)-- Sept. 5, 2001

Clinical Validation Essential to Demonstrating

Patient Benefits of Disease Markers

Genomics Collaborative, Inc. (GCI), a clinical functional genomics company, and Specialty Laboratories, Inc. (Specialty) (NYSE:SP), a leading research-driven clinical reference laboratory, announced a research collaboration to study the clinical significance of new laboratory markers of disease.

The collaboration combines GCI's high throughput genetic analysis tools and extensive specimen resources with Specialty's established test development and commercialization expertise. Initially, the two companies will work together to demonstrate the clinical utility of certain genetic markers in the racially diverse U.S. patient population. Associating the health risks of a disease with genetic markers through clinical validation is the first step in demonstrating the patient benefit of these tests.

"Our agreement with Specialty Laboratories leverages our core asset, the unparalleled Global Repository(TM), to produce therapeutic and diagnostic products that are effective in the diverse populations of North America, Asia, and Europe. Global Repository(TM) contains the DNA, sera and snap-frozen tissue samples from over 100,000 patients that are linked to detailed medical information that has been anonymized to ensure patient confidentiality," said Michael Pellini, M.D., chief executive officer of GCI. "In addition to advancing our internal product development program, GCI partners with industry leaders who bring complementary expertise to develop additional products. To this end, we are very pleased to work with Specialty, whose assay development capabilities and national distribution network are unmatched."

"The co-discovery relationship between Specialty and GCI addresses the fundamental question which new genetic tests must successfully answer: Does the test ensure patient benefit?" noted James B. Peter, M.D., Ph.D., chairman and chief executive officer of Specialty Laboratories. "Specialty Laboratories has earned its reputation in the health care industry by providing physicians with cutting-edge and clinically proven laboratory tools to better manage patients, resulting in customized patient care. Each new assay we offer must go through the critical steps of analytical and clinical validation followed by definition of clinical utility in order for the assay to be useful in patient care. GCI's experienced R&D and biostatistics teams have put together an incredibly valuable resource in the form of the Global Repository(TM) that will greatly facilitate this process as Specialty prepares new tests, including its COL1A1 test, Osteoporosis GenotypR(TM)/Col1A1, for commercialization."

About Specialty Laboratories

Specialty Laboratories, Inc. is the largest single source of esoteric testing in the United States, providing more than 3,500 esoteric tests to hospitals, laboratories and specialist physicians. As a leading research-driven clinical reference laboratory, Specialty works extensively with medical discovery companies to co-discover new tests, transforming research into incisive clinical tools for improved diagnosis and monitoring of disease. These co-discovery partnerships build on Specialty's track record of introducing assays characterized by exceptional analytical validation, clinical validation and the establishment of clinical utility. For more information on Specialty, visit www.specialtylabs.com.

About Genomics Collaborative

Genomics Collaborative, Inc. ("GCI") is a clinical functional genomic company with a comprehensive, clinical approach to discovery. GCI maintains Global Repository(TM), an unparalleled, large-scale resource of appropriately consented clinical research material, including human DNA, sera, and snap-frozen tissue samples, linked to detailed material information collected from patient populations worldwide. To date, the Company has recruited over 100,000 patients in Global Repository(TM), and collections continue in cardiovascular disease, inflammatory disease, metabolic disorders, various cancers, and other disease states. GCI and its collaborators apply a suite of high throughput genomic analysis tools in research conducted leveraging the assets of Global Repository(TM), placing the Company at the forefront of next generation target discovery and validation. GCI has also introduced GCI Access, a unique service offering to the pharmaceutical and biotech industry, allowing customer access to the samples and clinical data of Global Repository.

GCI Rigorous Ethical Standards

GCI is committed to maintaining the highest ethical standards possible, and to that end, meets quarterly with a distinguished Bioethics Advisory Board that has been invaluable in developing innovative solutions to the range of ethical problems posed by genetic research. In addition, GCI has created a proprietary system for anonymizing collections while ensuring data quality and protecting patient confidentiality.

Informed consent and patient rights are key to GCI's operations, and ensure sample quality while maintaining pristine ethical standards. Working with international leaders in the area of informed consent for genetic research, GCI has developed consent procedures appropriate to the repository context.

Safe Harbor Statement - Specialty Laboratories, Inc.

This release contains forward-looking statements that involve risks and uncertainties, including but not limited to, statements concerning the ability of Global Repository to produce therapeutic and diagnostic products that are effective in diverse populations, the ability of Global Repository to facilitate the assay validation process, the ability to develop and commercialize new assays based on GCI's technology, including Global Repository, the acceptance of new products by Specialty's customers, growth in demand for Specialty's services, potential returns on investments in R & D, and the opportunity of esoteric testing in general. Actual results may differ materially from the results predicted. Important factors which could cause our actual results to differ materially from those expressed or implied in the forward-looking statements are detailed under "Risk Factors" in filings with the Securities and Exchange Commission made from time to time by Specialty Laboratories, including our Registration Statement on Form S-1 declared effective on December 8, 2000 and our periodic filings on Forms 10-K, 10-Q and 8-K. Specialty undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.