BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - 18 Dec 1995.
Once thought to be on its way to eradication, tuberculosis has reemerged as a public health concern across the world, increasing more than 12 percent from 1988 to 1993 in this country alone. It is the leading cause of death of all infectious diseases worldwide.
Diagnosis of tuberculosis is usually confirmed by growing TB bacteria from patient specimens. This normally takes up to eight weeks. With the new Gen-Probe Amplified Mycobacterium Tuberculosis Direct (MTD) Test, it takes only four to five hours to get test results. Thus, the Amplified MTD Test allows physicians to treat patients quickly, minimizes unnecessary patient isolation, and decreases morbidity, mortality and overall medical costs associated with tuberculosis.
"The Gen-Probe Amplified MTD Test enables physicians to diagnose with confidence and to begin treatment promptly on smear-positive, previously untreated patients," said Henry Nordhoff, Gen-Probe's president and chief executive officer.
Genetic Probe Technology ------------------------
Every living organism has a unique genetic structure. The blueprint specifying how each organism is built is deoxyribonucleic acid (DNA). Understanding the DNA molecule is essential to understanding how DNA probes work.
The DNA molecule has the form of a twisted ladder, or double helix. The sequence of rungs on the ladder is what distinguishes one organism from another. To make a new identical copy of the DNA molecule, the two strands separate, becoming templates for new complementary strands. This ongoing process continuously duplicates the number of DNA molecules.
DNA probes are short segments of DNA that bind specifically to the unique sequence of DNA in the organism to be detected. Scientists can tailor-make these probes to be completely specific for a certain organism. It is this high degree of accuracy for one species that is the genetic probe's greatest advantage over other available tests.
Gen-Probe's MTD Technology --------------------------
Gen-Probe's Amplified MTD Test uses three core proprietary technologies to identify the presence of Mycobacterium tuberculosis with sensitivity and specificity of 95.5 percent and 100 percent, respectively, on smear-positive samples.
- rRNA -- The Amplified MTD Test targets ribosomal RNA (rRNA) instead of DNA to detect TB. rRNA is similar to DNA in many ways, but it naturally exists as single strands that can directly unite with DNA probes. Because there are thousands of rRNA molecules per TB cell, the Amplified MTD Test is more sensitive and reliable than tests which target a single DNA molecule found in each cell.
- TMA -- Through Transcription Mediated Amplification (TMA), Gen-Probe harnesses the natural process of RNA transcription to replicate rRNA sequences more than one billion-fold. This process ensures a fast and accurate diagnosis.
- HPA -- Using a Hybridization Protection Assay (HPA) and a chemiluminescent label that gives off light when detecting target organisms, MTD identifies only those gene sequences of actual Mycobacterium tuberculosis that have bound to MTD genetic probes. In this way, unbound genetic probes go undetected, avoiding false positives.
"In an effort to provide easier and more effective ways to diagnose infectious diseases, Gen-Probe takes innovative core technologies from the research laboratory into routine clinical laboratory use," added Nordhoff. "The new Amplified MTD Test is the most recent example of this commitment."
Resurgence of TB ----------------
Tuberculosis is an airborne infectious disease which is spread from person to person by activities such as repeated coughing and sneezing. Currently the leading cause of death resulting from infectious disease worldwide, there are a total of 8 million new cases of TB each year and 3 million deaths.
TB made a resurgence in the United States beginning in the mid-1980s. In fact, TB cases in the United States increased more than 12 percent from 1988 to 1993. There are approximately 10 million Americans infected with tuberculosis bacteria, and an estimated 10 percent of them will develop active tuberculosis.
In New York City alone, TB has increased 142 percent over the past 10 years. The disease has a 40 percent to 60 percent fatality rate when left untreated.
The problem of TB management and control has been compounded with the emergence of multi-drug-resistant TB and a growing population of highly susceptible HIV hosts.
According to the Centers for Disease Control and Prevention, the 10 highest case rates of TB in the United States are found in:
Atlanta -- 76.4 (a) Newark, N.J. -- 71.8 New York -- 50.3 Miami -- 48.5 San Francisco -- 46.0 Oakland, Calif. -- 40.9 Houston -- 34.5 Tampa, Fla. -- 31.1 Los Angeles -- 30.6 Santa Ana, Calif. -- 30.0
(a) All figures correspond to number of cases per 100,000 people.
Gen-Probe Inc. --------------
Based in San Diego, Gen-Probe is the recognized world leader in the development, manufacture and commercialization of diagnostic products based on its patented genetic probe technology. The company has received more than 35 FDA clearances for genetic probe products that test for a wide range of microorganisms that cause tuberculosis, strep throat, pneumonia, fungal infections and sexually transmitted diseases.
Gen-Probe is one of the few profitable biotechnology companies, with worldwide sales of more than $60 million in 1994. With 370 employees, Gen-Probe is one of the largest biotechnology companies in San Diego.
While it is a wholly owned subsidiary of Chugai Pharmaceutical Co. Ltd., Gen-Probe functions as a nearly autonomous biotechnology company, gaining support from Chugai when needed to allow Gen-Probe to realize its advances in medical technology.
Chugai Pharmaceuticals, the ninth-largest and fastest-growing pharmaceutical company in Japan, spends the highest percentage of its sales on R&D than any other Japanese pharmaceutical company.
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