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Biotech / Medical : Visible Genetics Inc.(VGIN) -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (226)	7/2/1998 5:58:00 PM
From: Steve Lokness	Respond to of 337

Richard and/or Rod; I was under the impression that VGINF was in the forefront of testing for resistant strains of HIV. Is this the case or is LabCorp mentioned by Richard ahead of Visible Genetics? Who is developing test for drug resistant bacteria? The potential for a fast reliable (genetic?) test must be huge as hospitals continue to deal with the resistance problems. The one thing that seems to make drug resistant bacteria more of a problem where they mutate further, is to continually throw antibiotcs at them when they are already resistant. IOW killing off the non-resistant bacteria creates a situation where the resistant strains mushroom. So............the importance of detecting the different strain. Thanks; Steve

To: scaram(o)uche who wrote (226)	7/5/1998 9:37:00 PM
From: Rod Gilchrist	Read Replies (2) \| Respond to of 337

Rick, > First, LabCorp has a testing service going before you? It's possible LabCorp will have a service running soon. The way this stuff works is there are two routes to putting a commercial test on the market. One is to have a test FDA approved in which case who is allowed to sell the test commercially is relatively open. The other route is for the lab that does the test to be certified under CLIA '88 to perform 'complex tests'. In this case its the level of expertise and the rules of operation of the lab are defined such that the public is protected. Our test is available now, and could be used in a CLIA '88 environment, as well as for research purposes such as drug testing (and there is a lot of that going on). But we don't own a CLIA '88 lab ourselves. (VGI has acquired two labs in the last year that have significant HIV genotyping experience, namely Applied Sciences and ACTGene, but I belive these labs do genotyping for research and customer support purposes and are not actually operating under CLIA '88.) Bear in mind that we have so few shares outstanding that 30,000 to 50,000 assays a year means a dollar per share revenue and if that was on top of being at break even (which we are not currently) that alone could justify a $30 stock price (using CR's earnings multiple). So we don't need to own the whole market. Also we've been endevoring to convince people that geneotyping HIV is a good idea for some time. Now we have at least two recent events helping us out. One is the article on genotyping HIV in the June 24 issue of the Journal of the American Medical Association (JAMA) and another is a 'big dog' (LabCorp) coming on side. One way of looking at the latter event is that it leaves other big dogs with a time to market issue for which we have a solution. Given the level of experience with HIV genotyping in place at our lab facilities in Atlanta and Paris and the fact that we offer hands on training for using our kits and sequencers at these two sites we could help get CLIA '88 competition for LabCorp on-line very quickly. > Does their testing service have any deficiencies relative to > those planned for VGINF? In terms of LabCorp deficiencies the obvious thing from their press releases are the turn around times 5-10 working days for genotyping and 3-4 weeks for phenotyping. If you have a viral load break out these are really long times. Our test takes about 10 hours to process; sample to results (30 minutes of which is actually running on the sequencer). I haven't heard, at this point, how well their test works, whether they can detect all drug resistant mutations or what their selling price is. (I'd be interesting in hearing if anyone knows any of these.) On the VGI side, we do both 3' and 5' sequencing across the whole of the Protease and Reverse Transcriptase genes and use the redundant information to generate sequencing results with a high level of confidence. Our Clip chemistry lets the 3' and 5' reactions be done in the same tube and thus cuts down chemistry steps. Also the FDA certification effort is leading us to a progressively more characterized test (there will be an amazing amount of statistics generated in support of the eventual approval), and a fully cGMP compliant manufacturing and quality control process. > Are you still collaborating with (I forget the name of the > clinical lab) the company headquartered in Van Nuys, California? This will be Clinical Partners you are referring to. The founder, Richard Daly, joined our board on June 18th. So yes, that colaboration is alive and well. biz.yahoo.com > Second, the "testimonial" for the service is given by > John Mellors, from your own "Gene Foundry Inc. backyard". Yes, that was an interesting quote, wasn't it. I don't know John Mellors myself or what his exact relationship is to VGI, but it sort of seems like that choice was deliberately aimed at us. Its flattering really when a $1.5B company appears to feel it necessary to take a swipe at a $3M (last year anyway) company. It suggests that they see us as competition. > Could you point us to an update relating to Gene Foundry? This operation is also alive and well and quite busy developing new applications of our existing tests as well as developing new tests, but I don't think there has been any recent public discussion. > In addition to genotyping, are you planning on providing > phenotyping data? A couple of definitions from a text book: genotyping means determining the genetic constitution of an organism; phenotyping means determining the physical appearance/observable characteristics of an organism. The point of the VGI HIV GeneKit is to establish the resistance of the virus to various drug therapies. This is very much phenotype rather than genotype related information. If the referring physician doesn't end up with an understanding of the drug resistance of the HIV in his patient, we haven't succeeded in putting a full value chain in place, and we are certainly focused on delivering the entire value chain. According to the July issue of Scientific American (this month's Science is purportedly focused on HIV as well), we know more about the HIV virus than any other virus. There is an extremely active scientific community gathering and publishing links between genotype and phenotype (between mutations and drug resistance). See for example: viral-resistance.com LabCorp's press release suggests that directly measuring phenotype for each patient sample is a significant value add for their HIV test suite. I can see that being a good thing for some organisms, notably where a genotyping test can't cover the whole region of interest or where there is poor information on the meaning of mutations. But it seems much less useful for an individual HIV patient sample, particularly given the 3-4 week turnaround. I think you want a really quick answer when you see the viral load is up. > Thanks for any pointers, Rick Hope this helps. - Rod Disclaimer: I work for VGI, but I definately don't speak for the company. The opinions here are my own. I'm not a Molecular Biologist, an M.D. nor an investment advisor. I'm an engineer and an investor in the stock. Please take time to verify whatever you read here that's important to you. Its pretty much all available from public sources.