Specialty Laboratories and VIRalliance Introduce Phenoscript, Assay for Identifying Resistance to HIV Therapy Business Wire
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Specialty Laboratories and VIRalliance Introduce Phenoscript, Assay for Identifying Resistance to HIV Therapy

Business Wire -December 13,2001


SANTA MONICA, Calif. & PARIS--Specialty Expands its Comprehensive Suite of HIV Testing to Become First Full Service Laboratory Offering In-House Phenotyping

Specialty Laboratories, Inc. (NYSE:SP) (Specialty), a leading research-driven clinical reference laboratory, and VIRalliance, a subsidiary of BioAlliance, "The Drug Resistance Company," today announced the final technology transfer and U.S. introduction of Phenoscript(TM), a new proprietary test to predict resistance to antiviral drugs used in HIV therapy. Phenoscript(TM) is an HIV phenotyping test, developed by VIRalliance, in collaboration with the Pasteur Institute and the Institut National de la Sante et de la Recherche Medicale (INSERM). Physicians use the test to select the most effective HIV drug therapy for the individual patient.

Treatment failure can occur in HIV/AIDS patients when the virus develops resistance to drug therapy. Phenoscript(TM) is a treatment-monitoring test that directly measures, under controlled laboratory conditions, the effect of a drug on growth of the patient's viral population, resulting in the identification of optimal drug combinations for the individual patient.

"The introduction of Phenoscript(TM) continues Specialty's leadership in HIV testing and laboratory services to the infectious disease community," noted James B. Peter, M.D., Ph.D., chairman and chief executive officer of Specialty Laboratories. "Through collaboration with VIRalliance, Specialty is now the first and only full-service commercial reference laboratory in the United States to perform phenotypic resistance testing internally. By offering the entire spectrum of recognized HIV resistance tests and performing them under one roof, Specialty delivers added benefit to patients and clients through the resultant improvements in quality control and turnaround-time."

"VIRalliance and BioAlliance Pharma are very pleased to join with Specialty to make our phenotyping technology available to HIV patients and their physicians in the United States," said Dominique Costantini, M.D., chairman and chief executive officer of BioAlliance Pharma. "Phenoscript(TM) is a robust and clinically validated assay. In two independent studies reported at the 5th International Workshop on HIV Drug Resistance and Treatment Strategies in June 2001, Phenoscript(TM) demonstrated excellent overall correlation with existing commercial phenotyping processes."

Specialty's leadership in HIV testing dates back to 1986 when the Company offered its first diagnostic tests for Human T-Cell Lymphotrophic Virus III, an early classification of Type 1 HIV. Many "firsts" in HIV test introductions followed. In 1988, Specialty became the first commercial laboratory to offer HIV diagnostic testing by Polymerase Chain Reaction (PCR). Specialty's introduction of HIV AccuQuant(R) in 1994 and HIV GenotypR(TM) in 1996 helped establish resistance testing as a routine practice in the clinical management of HIV/AIDS.

Specialty offers a comprehensive suite of more than 60 HIV-1 related tests to assist in patient management, from diagnosis through therapeutic drug monitoring. Specialty also maintains an active research program and development pipeline, powered by both internal research and strategic alliances. Currently under development are tests for HIV-specific immune function, non-progressor evaluation and hyperlipidemia prediction.

About Phenoscript(TM)

The medical community has embraced phenotypic resistance testing for its direct, quantitative assessment of susceptibility and strong clinical correlation with treatment response. Phenoscript(TM) builds on these benefits. The test features a novel single cycle replication technique developed by VIRalliance in collaboration with the Pasteur Institute and INSERM in Paris, under the leadership of Francois Clavel, M.D.

The superior reliability and accuracy of Phenoscript(TM) have been validated through extensive study by independent investigators and Specialty Laboratories. Meeta Patnaik, Director of Research, Tatayana L. Yashina, Ph.D., Senior Research Scientist and Andreas Bakker, Ph.D., Clinical Scientist, all of Specialty Laboratories, led the team of scientists who performed the successful technology transfer and internal validation of the assay.

Key advantages of Phenoscript(TM) include:

-- More clinical cut-offs. Because clinical cut-off computations are based on the actual correlation between phenotype and clinical response in patients, they provide a more precise estimation of the potential contribution of any single drug to a multiple-drug therapy.

-- Reduced turnaround-time.

-- Access to Specialty's comprehensive menu of more than 60 HIV-related tests, including GenotypR(TM)PLUS and Therapeutic Drug Monitoring tests.

-- Full service, "one-stop shopping" for clinical reference testing including national logistical support.

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 accessible clinical tools for creating customized medical care via laboratory medicine. 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 VIRalliance

VIRalliance is a subsidiary of BioAlliance Pharma, "The Drug Resistance Company." BioAlliance Pharma is a biotechnology company specializing in treatments and technologies to better fight drug resistance in the field of infectious diseases and cancer. The Company's goal is to provide patients and their caregivers with practical therapeutic solutions. Thanks to their strong alliances with numerous European academic research institutes and strategic collaborations with pharmaceutical companies, BioAlliance Pharma and VIRalliance collaborate with the most talented experts in the domains of virology and cancer. The companies focus on the identification of new therapeutic targets, the improved targeting of drugs and the development of biological technologies for predicting drug resistance. BioAlliance pharma has a development portfolio of novel drugs (including an HIV anti-integrase program) and innovative predictive tests to aid the optimal treatment of cancer and viral diseases.

More information about BioAlliance and VIRalliance and their respective development programs can be found at www.bioalliancepharma.com and www.viralliance.com.

Safe Harbor Statement

This release contains forward-looking statements that involve risks and uncertainties, including, but not limited to, statements concerning our continued leadership in HIV testing and laboratory services, that we offer the full spectrum of recognized HIV resistance tests resulting in improvements in quality control and turnaround-time, concerning our commitment to providing clinically incisive tools to ensure the best possible HIV and AIDS care at every stage, and that our continued relationship with VIRalliance will remain strong. There can be no assurance that Phenoscript(TM) will work in the manner predicted, or at all, that Phenoscript(TM) will be adopted by physicians, that Phenoscript(TM) will generate revenue or that Phenoscript(TM) will deliver added benefits to us, our clients or to patients. 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.

CONTACT: Specialty Laboratories Greg Mann Director, Corporate Communications 310/586-7261 gmann@specialtylabs.com or BioAlliance Pharma Olivier Lefevre VP, Business Development 33 (0) 1 45 58 76 03 olivier.lefevre@bioalliancepharma.com
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