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Biotech / Medical : IMI:TSE International Medical Innovations Inc. -- Ignore unavailable to you. Want to Upgrade?


To: thebeach who wrote (17)11/15/2002 12:03:18 PM
From: gg cox  Read Replies (1) | Respond to of 66
 
Harry Kane from stockhouse.
stockhouse.com;

The last NR says there are 3 Colorectalert clinical trials,
not the 2 mentioned on the website.
Here's some clarification:

The first trial (669 souls) ended May 2000.
It compared ColorectAlert (CRA) with fecal occult blood test (FOBT) and carcinoembryonic antigen (CEA= blood test)
in screening for cancerous and pre-cancerous conditions.
A Colonoscopy was then done to determine the actual presence of disease in each patient.

The result: all three tests detected 81 % of the cancers (sensitivity), but ColorectAlert was much more specific (77%),
which means it produced significantly fewer false positive results than either FOBT (58%) or CEA (52%).
ColorectAlert was even more sensitive than FOBT and CEA for early stage (A and B) cancers, and for cancers in asymptomatic patients.

Here are the specificity results of the first trials:
ColorectAlertâ„¢ (CRA) alone.... 77 per cent
Fecal occult blood test (FOBT) alone... 58 per cent
Carcinoembryonic antigen (CEA) alone... 52 per cent
FOBT+CEA... 78 per cent
CRA + FOBT... 88 per cent
CRA + CEA... 90 per cent

Conclusion of the first trial:
Because of its superior specificity,
ColorectAlert has the potential to improve the cost-effectiveness
of colorectal cancer screening programs without compromising sensitivity.
The test is inexpensive and painless, does not require a blood test or stool sample,
and does not require any dietary changes prior to obtaining the sample.

The ColorectAlert test requires a sample of rectal mucus to be taken by a doctor during a digital (gloved finger) rectal exam.
This sample can be taken during a routine doctor visit when many people are already undergoing rectal exams.
The sample is smeared onto a small card with a membrane surface, and sent to a laboratory.
At the laboratory the sample is treated with the enzyme galactose oxidase, then stained with Schiff's reagent, which produces a color change.
The treated sample is read with a color reader (spectrophotometer) to quantify the color change and determine the numeric ColorectAlert value.

The second clinical trial of 750 additional patients was performed at St. Michael's Hospital, in a follow-up study led by Dr. Marcon.
Two mucous samples are taken from each patient, who will also undergo colonoscopy.
The results will deepen and expand the clinical evidence behind ColorectAlert and will establish the reproducibility of the test.
This trial is due for reporting except...

A 3rd trial was alluded to in the recent NR:
'In three major studies ColorectAlert has been tested on more than 2,200 samples.'
The 3rd trial appears to be an expansion of trial 2, also by Dr. Marcon.
It involved an additional 500 patients and a further assay of existing samples.

The object is to write up the results + report all of the information together
at a medical meeting in the spring.

Reminder:
Webcast Date: Monday, November 18, 2002
Time: 10:30 a.m. Eastern Time
Conference Call Numbers: (416) 405-9328 (Toronto) (800) 387-6216 (North America toll free)
Please call five minutes prior to the start time and specify the IMI call chaired by Dr. Brent Norton.
Following its completion, a replay of the call can be accessed for three months
on the Investor page of IMI’s web site www.imimedical.com
or for one week by dialing (416) 695-5800 or (800) 408-3053 (U.S. & Canada) and entering access code 1306686.