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Biotech / Medical : IGEN International -- Ignore unavailable to you. Want to Upgrade?

To: John Zwiener who wrote (645)	6/1/2001 9:12:37 AM
From: Biomaven	Read Replies (1) \| Respond to of 1025

Agreed - this could be very significant. Here are the two abstracts Evaluation of an Electrochemiluminescent Immunoassay for the Direct Detection of Food Borne Pathogens in Human Fecal Samples R. J. Obiso, J. White IGEN International, Inc., Gaithersburg, MD Presentation Number: V-12 Keywords: electrochemiluminescence, food borne pathogens, pathogen detection Detection of most gastrointestinal pathogens in fecal samples is based on the isolation of the pathogen using selective agar plates, followed by biochemical identification and possible serological classification. These procedures may take as long as 4 days. Therefore, a more rapid method is required to determine the presence of these pathogens in feces. Further, ELISA- and PCR-based methods to detect antigen or virulence genes require sample processing, sample washing, or even DNA/RNA purification methods. In this study, the clinical utility of ORIGEN® electrochemiluminescent (ECL) immunoassays were evaluated in human fecal samples. To evaluate the capacity of ORIGEN technology, human fecal samples were collected and tested for the presence of E. coli O157, Salmonella species, and Campylobacter species using IGEN International’s PATHIGENTM detection assays (PATHIGEN E. coli O157 test, Salmonella test, and Campylobacter test), which are currently used to detect food borne pathogens in food and water samples. For pure bacterial cultures, the sensitivities of the PATHIGEN tests are in the range of 100-5000 bacteria, making direct detection from feces possible. Direct detection of specific bacteria in feces was performed for each pathogen tested. The level of sensitivity was comparable to pathogens detected in food and water samples (spiking studies). To assess the assays’ performance clinically, fecal samples from patients were subjected to routine culture techniques and the ORIGEN–based tests. The assay takes approximately 1.5 h without a need for enrichment of the samples. These methods to detect food borne pathogens in feces may be useful for a rapid clinical diagnosis of gastrointestinal infection. Development and Evaluation of an Electrochemiluminescence-Based Immunoassay for the Detection of E. coli O157 in Food C. C. Young, Z. Abbas, R. J. Obiso, J. A. White IGEN International, Inc., Gaithersburg, MD Presentation Number: P-79 Keywords: E. coli O157, detection, electrochemiluminescence The increased sensitivity of newly developed culture-based methods that utilize immunomagnetic bead capture for the detection of E. coli O157 has resulted in the identification of positive samples that had previously gone undetected. Current immunoassay formats used to screen foods, such as ELISA and lateral flow device technologies, are less sensitive than these new, culture-based methods. Therefore, the development of more sensitive rapid detection methods is critical to provide a screening test prior to culture confirmation. In this study, an ORIGEN®-based electrochemiluminescent immunoassay (PATHIGENTM E. coli O157 Test) for the detection of E. coli O157 in food matrices was developed and evaluated. The assay could detect as few as 100 E. coli O157 cells in a variety of food matrices allowing detection after enrichment times as short as 6 hours. This sensitivity was 2-4 logs greater than commercially available ELISA and lateral flow device immunoassay formats and was equivalent to the newly available culture methods. A random screen of 500 food samples using the PATHIGEN E. coli O157 Test followed by confirmation using immunomagnetic bead separation and plating onto RainbowTM Agar, was conducted. In this study, 40 additional E. coli O157 positive samples were confirmed that were not detected using a combination of standard screening and plating methods. Based on this data, we conclude that routine use of more sensitive screening methods is vital to protecting the food supply from foods contaminated with E. coli O157. One discrepancy between the abstract and the PR is the time needed for the assay. Abstract says 1 1/2 hours, whereas the PR says (speaking more generally) as little as 10 minutes. For a doctor's office POC 1 1/2 hours is too long for a "while you wait" test. But still clearly much better than the 1-2 days it presently takes to just culture a sample. Peter

To: John Zwiener who wrote (645)	8/3/2003 11:38:08 PM
From: James Perry	Respond to of 1025

John, I certainly want to pay tribute to you for introducing me to Igen. I owe you many thanks. My first purchase was in 1996, and I stayed the course. I felt the Igen risk was a bit too great in the heat of MSD, and reduced my exposure from about 80% of my portfolio to a more prudent 25%. But I never doubted your praises for the technology. I did by best to accomodate to a deal I hardly could care for, but picked up sufficient calls to double that latter holding just before Sam revealed the settlement. Actually, I bought July calls a week before they expired. When settlement did not come the week end I expected it, two market days after I bought them, I took a small loss on those and rolled into August calls. So I will remain quite long on Newco. And my account will certainly enjoy the cash lubrication. BTW, don't know if you have monitored the Yahoo board, but think you were aware that I picked up afflictions of lung and prostate cancer. Good luck dogs my path. The PSA is .1 following radiation seeding, and lung surgery failed but I entered the Iressa trials and my three substantial lung lesions disappeared more than six months ago. Meanwhile the VA agreed my problem resulted from atomic radiation at Bikini tests right after WWII, and allowed me total service connected disability. Of course, I am on oxygen, but still enjoying life with gusto. Best of luck and many thanks to you!