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


To: Steve Lokness who wrote (154)3/1/1998 9:27:00 PM
From: Rod Gilchrist  Respond to of 337
 
Hi Steve,

No, VGINF is still happily making good progress and is
still based in Toronto. Applied Science has been a very
good thing for us, but HIV is just one of many thrusts
(one of the more important of course).

You emailed info@visgen.com? Let me know your snail mail
address and I'll see you get a package. I'll also check
out the email address.

You are right it is awful quiet on this group. I'd love
to hear more discussion myself.

- Rod



To: Steve Lokness who wrote (154)3/4/1998 10:26:00 AM
From: debra vogt  Read Replies (1) | Respond to of 337
 
Visible Genetics announcement/trial

March 4, 1998 07:54 AM

(Full text of press release from Canada NewsWire)

VISIBLE GENETICS INC. REPORTS 98% ACCURACY FROM FIRST RETROSPECTIVE HUMAN PAPILLOMAVIRUS VIRUS (HPV) GENOTYPING TRIAL

TORONTO, March 4 /CNW/ - Visible Genetics Inc. (VGI) (Nasdaq: VGINF) has successfully completed a retrospective trial of its human papillomavirus (HPV) genotyping diagnostic test. The trial was conducted at McMaster University, Regional Virology Laboratory, Ontario, Canada. The VGI Clinical HPV test uses a proprietary single nucleotide DNA sequencing method to genotype HPV. The VGI test was compared to full four-nucleotide DNA sequencing, to an FDA approved DNA probe-based test, and to a set of DNA probes commonly used to genotype HPV (the homebrew'' DNA probes). The trial was based on 115 cervical specimens collected from women who underwent colposcopic examination for an abnormal Pap smear. VGI's clinical test was 98.3% consistent (1.7% error rate) with all of the genotypes found based upon full DNA sequencing, the FDA approved probe test was 82.9% consistent with the full DNA sequence (17.1% error rate), and 81.9% consistent with the homebrew DNA probes.

Human papillomavirus has been linked to cervical cancer in women. Over 70 different HPV genotypes have been identified, and 23 of these are known to be oncogenic, because they have been associated with cervical cancer. The VGI HPV genotyping kit utilizes the Company's proprietary clinical DNA sequencer and testing methodology to provide accurate, low cost, timely results. VGI's proprietary single nucleotide approach used in its HPV Clinical GeneKit gave the same results as the as full DNA sequencing in 113 out of 115 tests. The advantages of the single lane method is reduced cost, simple laboratory procedures, increased throughput and reduced labor. The VGI tests provides a detailed report characterizing the HPV genotype, rather than simply categorizing types into low, moderate or high risk.

Dr. Jim Mahony, Director of the McMaster University Regional Virology Laboratory, stated, The VGI clinical test performed extremely well in the trial. It actually identified four new oncogenic genotypes that were missed by the commercially available probe-based products as well as the homebrew tests. I was particularly impressed by the simplicity and accuracy of the VGI approach, and the fact that it provides detailed genotypic information on known genotypes.

It was an unexpected surprise that it also identified new genotypes.''

Sequencing is the only way to detect all possible variations in the DNA sequence, or genotype, of the virus.

Probe-based tests can detect a limited number of sequences -- a different probe is required for each unique sequence. The cost and complexity of the test increases as the number of different probes increases, and it becomes difficult to separate one genotype from another.

The results of this first HPV trial are quite encouraging, however we will have to expand these trials to a much larger sample size to establish solid statistical results,'' stated John K. Stevens, Chairman and CEO of VGI. Our plans are to quickly perform additional clinical trials at other international sites and submit our HPV Clinical GeneKit for FDA approval later this year. Over 55 million Pap smears are performed each year in North America, and about 4 million are equivocal. We see the HPV testing market in this equivocal population as an important opportunity for our clinical kit.''

Visible Genetics Inc. develops, manufactures and markets high performance, automated DNA sequencing systems for the analysis of genes linked to disease. The Company's OpenGene system employs stratified DNA testing and single-tube, single-step sequencing methods to significantly reduce the time and cost involved in finding and identifying genetic mutations and important natural genetic variations.

/For further information: John K. Stevens, Chairman and C.E.O. of Visible Genetics Inc., (416) 813-3242, or john(at)visgen.com/

REUTERS