Trade News

New York, March 24, 1998

Experts convene to discuss improved diagnosis of TB PCR TB

Assist Line is Created to Help Health Care Professionals Share Information

Infectious disease experts from throughout the United States gathered in New York today, "World TB Day," to learn about the formation of an information and consultation service that will help physicians become aware of how PCR technology can be used in the diagnosis of tuberculosis (TB). Once thought to be a defeated health threat, TB continues to be the leading infectious disease cause of death globally, and a serious concern to health care professionals in the United States.

By calling a toll-free number, 1-888-TB-PCR-08, medical professionals can now access a panel of expert specialists who will respond to PCR TB-related questions within 24 hours. An On-Line Library with an index of published articles, diagnostic and laboratory protocols, and educational information will also be available.

"Roche is an example of a company accepting the challenge from the World Health Organization (WHO) to provide better overall treatment of TB by its development of PCR technology for the diagnosis of TB," said Lee Reichman, MD, director of the New Jersey Medical School National Tuberculosis Center and past president of the American Lung Association.

Roche Diagnostics is the manufacturer and marketer of the first rapid diagnostic test for the detection of Mycobacterium tuberculosis (MTB) based upon the widely publicized polymerase chain reaction (PCR) technology. By leveraging PCR, the AMPLICOR® MTB Test rapidly and reliably detects M. tuberculosis within hours, as opposed to weeks with conventional culture methods.

"The AMPLICOR MTB Test provides a reliable tool for confirming tuberculosis in untreated patients who have AFB (Acid Fast Bacilli) positive smear results," said Scott Rairigh, director of marketing, Immunochemistry and PCR for Laboratory Systems, a business unit of Roche Diagnostics. "With clinical trials that indicate 95 percent sensitivity and 100 percent specificity in this patient population, physicians can have more confidence early in their treatment decisions. The packaging of PCR in a user-friendly kit for laboratories offers broad access to the technology's clinical benefits of high sensitivity and rapid test results which, we believe, will lead to improved patient care."

"It is of tremendous value, both clinically and economically, to have access to a rapid test for TB," acknowledged Richard F. D'Amato, Ph.D., director, division of clinical microbiology and co-director of infection control at the Catholic Medical Center of Brooklyn and Queens, Jamaica, New York. "Not only does earlier detection lead to improved patient care for individuals suspected of having the disease, but our preliminary analysis has also shown that rapid diagnosis has lead to overall savings within the hospital. Faster diagnosis means patients can be more appropriately managed at an earlier stage, resulting in more efficient utilization of hospital resources."

Traditional diagnostic techniques, such as culture and microscopic examination of AFB smear samples, are fraught with challenges. With certain specimens taking up to eight weeks to detect with culture, patients are routinely started on treatment with minimal diagnostic information. While AFB smear results can be available within one day, they are only 50 to 70 percent sensitive and do not distinguish between M. tuberculosis and the many other acid-fast organisms that can be present. This makes patient diagnosis extremely difficult, particularly in high-risk cases where patients are immunocompromised. In many such patients, symptoms from other mycobacterial infections such as M. avium or M. intracellulare may be present which closely mimic those of TB, but these infections are not contagious and require alternate therapeutic approaches.

About Roche's AMPLICOR® PCR Products:

In the United States, the AMPLICOR HIV-1 MONITOR, AMPLICOR® MTB and AMPLICOR® Chlamydia trachomatis tests have received FDA marketing clearance. Components of the laboratory-ready kits are pre-packaged, standardized and ready for use.

In June 1997, Roche's COBAS AMPLICOR system and related Chlamydia trachomatis reagent were also cleared for marketing by the FDA. COBAS AMPLICOR is an automated bench-top batch analyzer that allows clinical laboratories to perform infectious disease testing on PCR-ready specimens. The COBAS AMPLICOR analyzer performs both amplification and detection, and is the first automated system with this capacity.

Roche's Mycobacterium tuberculosis test has been available on the COBAS AMPLICOR system since the system was launched in Europe in 1995. Performance comparisons of the microwell plate test and the version for the COBAS AMPLICOR system have just been completed in the U.S. and will be submitted to the FDA shortly as an amendment to the current PMA for Roche's FDA-approved AMPLICOR® MTB test. In addition, Roche launched its M. avium and M. intracellulare tests on the COBAS AMPLICOR system in Europe in late 1997. M. avium and M. intracellulare are both organisms that can cause the respiratory disease MAC (Mycobacterium avium complex) in immunocompromised patients.