HERCULES, CA — April 21, 2008 — Bio-Rad Laboratories, Inc. (AMEX: BIO and BIOb), a multinational manufacturer and distributor of life science research and clinical diagnostic products, announced the pending launch later this year of two regulatory tools for the ProteOn™ XPR36 Protein Interaction Array System: the ProteOn Manager™ 2.1 Security Edition Software and the ProteOn XPR36 Installation Qualification and Operation Qualification Kit. These regulatory tools will be key to pre-clinical and clinical development of therapeutics as well as manufacturing and quality control.
The ProteOn Manager 2.1 Security Edition Software is designed to assist customers in pharmaceutical drug development meet the requirements for 21 CFR part 11 by providing functionality for maintaining data security, data integrity, auditing, and the traceability of electronic records.
Key benefits of the ProteOn Manager 2.1 software include:
- Electronic signatures — reviewers and approvers will be able to digitally sign records. The name, date, time, reviewer/approver status, and reason will be associated with each signature and tracked by the software. All electronic signatures will require a username and password.
- Audit trail — all auditable changes will be recorded, including the date and time, originator of the record, and other related information. The audit trail cannot be changed or deleted by the user.
- Data validation — accuracy of electronic copies will be confirmed using a secure checksum to detect invalid or altered records.
- Identification codes and passwords — the system administrator will be able to set up a unique user identification code for each individual user. User identification codes cannot be reused or reassigned to others. The Windows operating system ensures that all active user identification codes are unique and that all identification code and password combinations are unique.
- Device check — the software will record the identity, such as the serial number of the ProteOn instrument that it is controlling.
- System permissions and authority — access rights will be based on those assigned within the Windows domain/ workstation user database. ProteOn Manager Security Edition software uses the Windows operating system security feature to authenticate users and retrieve access levels via group membership. User permissions will determine access to the software functions.
- Generation of copies — accurate and complete copies of the data will be generated within ProteOn Manager software, for example, using the "Save As" feature so it may be accessed later for inspection and review. The application also enables export of electronic records to ASCII, XML, or Excel file formats.
The ProteOn XPR36 Installation Qualification and Operation Qualification (IQ/OQ) Kit will enable drug discovery and development researchers to validate and record instrument performance. The IQ/OQ kit has been designed to test critical system functions to ensure reliability and consistency of system performance. The kit will include control reagents, fully automated software, and reporting functions. Key benefits include wizard-driven software, printable electronic reports for document control, electronic log of IQ/OQ and test results, ready-to-use reagents and sensor chip for testing system performance, and unattended operation.
Availability
The new software and kit will be available this summer. For further information, ordering information and availability, either contact your local sales representative, visit www.bio-rad.com, email to lsg.orders.us@bio-rad.com or call 1-800-424-6723.
About Bio-Rad
Bio-Rad Laboratories, Inc. (AMEX: BIO and BIOb) has remained at the center of scientific discovery for more than 50 years manufacturing and distributing a broad range of products for the life science research and clinical diagnostic markets. The company is renowned worldwide among hospitals, universities, major research institutions, as well as biotechnology and pharmaceutical companies for its commitment to quality and customer service. Founded in 1952, Bio-Rad is headquartered in Hercules, California, and serves more than 85,000 research and industry customers worldwide through its global network of operations. The company employs approximately 6,300 people globally and had revenues approaching $1.5 billion in 2007. For more information, visit www.bio-rad.com.
This release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally can be identified by the use of forward-looking terminology such as, "believe," "expect," "may," "will," "intend," "estimate," "continue," or similar expressions or the negative of those terms or expressions. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. For further information regarding the Company's risks and uncertainties, please refer to the "Risk Factors" in the Company's public reports filed with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2007, as updated by subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. Bio-Rad Laboratories, Inc. disclaims any obligation to update these forward-looking statements.