|Potentially very major news. These are the kind of products that will change how things are tested. Direct detection of pathogens from stool specimens. From what I gather, this will be far better than stool cultures and much cheaper.|
IGEN International, Inc. (ticker: IGEN, exchange: NASDAQ) News Release - 5/31/2001
IGEN Leveraging Food Safety Tests to Detect Human Infectious Diseases
Rapid Point-of-Care Tests Intended to Improve Patient Outcomes
GAITHERSBURG, Md., May 31 /PRNewswire/ -- IGEN International Inc. (Nasdaq: IGEN) announced today that it is moving to expand the market for its PATHIGEN(TM) test kits, currently used to screen food for potentially harmful bacteria, by adapting the kits for use in rapid tests for human gastrointestinal infections in point-of-care settings, such as physicians' offices and satellite laboratories in hospitals.
The technical feasibility of such adaptation was the subject of a presentation last week at the annual meeting of the American Society of Microbiology in Orlando, Fla. IGEN scientists reported the results of a study demonstrating that PATHIGEN tests detected two kinds of foodborne pathogens, Salmonella and Campylobacter, in human fecal samples without the need to grow the bacteria for 24 to 48 hours. The study also showed that PATHIGEN tests detected Salmonella, Campylobacter, and E. coli O157 in human fecal samples at levels from 100 to 10,000 times lower than levels of these bacteria found in fecal samples from people with gastrointestinal illness.
"We are not aware of any other tests for human gastrointestinal infections that have achieved this combination of rapid results and high sensitivity," said Richard J. Massey, Ph.D., IGEN's President and Chief Operating Officer. "These exciting and unprecedented results suggest that PATHIGEN tests may provide the best mix of speed and sensitivity of any bacterial detection method. These superior attributes will enable us to develop tests that will help physicians more quickly diagnose and treat patients infected with foodborne pathogens."
The PATHIGEN tests, based on the company's proprietary ORIGEN(R) technology, are capable of producing results in as little as 10 minutes because they eliminate the need for bacterial culture or sample handling steps such as washing. The current gold standard for detecting gastrointestinal pathogens involves bacterial culture and biochemical methods that can take as long as four days to provide a result. Newer, more rapid techniques have entered the market, but they require sample processing, washing, purification, culturing, and/or other steps. These newer methods usually take 24 hours or longer and generally are not as sensitive as the PATHIGEN tests.
PATHIGEN tests for human use could help physicians diagnose foodborne gastrointestinal illness more rapidly than current methods. Earlier diagnosis would allow for prompter treatment with the most appropriate antibiotics, better patient outcomes, and lower health care costs.
Such tests are subject to a regulatory mechanism known as a 510(k) filing, submitted to the U.S. Food and Drug Administration at least 90 days before the planned launch date. The 510(k) is a streamlined process, and IGEN believes it can complete development and regulatory requirements for the first PATHIGEN tests in approximately one year. IGEN expects initially to market human diagnostic tests for Salmonella, Campylobacter, E. coli O157, Listeria, and Shigella. The company is planning to develop tests for other gastrointestinal pathogens, including Cryptosporidium, Clostridium, and Giardia.
The tests would be performed using IGEN's ORIGEN Analyzer, which has already completed the 510(k) process and has been in commercial use for several years at hundreds of sites, including clinical testing laboratories. To complement the point-of-care product line, the company plans to introduce a clinical version of the M-SERIES(TM) M1 instrument now in development.
The annual worldwide market for microbiology tests for human use exceeds $1 billion. This market is likely to expand as a result of increased public awareness of deadly foodborne diseases. Market growth is also liable to be driven by the availability of faster, more sensitive tests, which may command higher prices for improved performance and encourage new or expanded applications, such as neonatal screening, epidemiological studies, and detection of subclinical infections.