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INSTI'R' HIV-1/HIV-2 Ultra Rapid Antibody Test Kit Canadian Trial Results Presented At The XV International AIDS Conference In Bangkok.


BANGKOK, Thailand & RICHMOND, British Columbia This page is for the city of Richmond, British Columbia. For the federal electoral district in this locality see Richmond (electoral district); for the provincial electoral district see Richmond (provincial electoral district).  & MISSISSAUGA, Ontario For the First Nation, see .

Mississauga (pronounced: [ˌmɪsɪˈsɑgə] listen  
 -- Hedley Technologies Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002)
TSX Transfer from Stack Pointer to Index
TSX True Space Extension
 Venture:HED HED High Energy Density
HED Hall Effect Device
HED Hypohidrotic Ectodermal Dysplasia
HED Historiae Ecclesiasticae (Doctor of Church History) Doctor, academic degree)

HED Human Energy Expenditure
HED Human Experience Development
) and BioLytical Laboratories Inc. announce that results from an extensive clinical trial of approximately 3,500 patients mandated by Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health.

Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare.
 for the INSTI(R) HIV-1/HIV-2 Ultra Rapid Antibody Test Kit (the "INSTI(R)") has been presented at the XV International AIDS Conference Education, networking and the promotion of best practice are essential to enhancing the response to HIV/AIDS. IAS conferences provide opportunities to share experience, and increase the knowledge and expertise of professionals working in HIV/AIDS.  in Bangkok, Thailand. The purpose of the clinical study was to evaluate the performance characteristics of the INSTI(R) in comparison to licensed laboratory-based tests.

All diagnostic and blood screening HIV testing HIV test Various tests have been used to detect HIV and production of antibodies thereto; some HTs shown below are no longer actively used, but are listed for completeness and context. See HIV, Immunoblot.  devices in Canada are regulated through the Bureau of Medical Devices, Health Canada. Currently there are no rapid HIV testing devices approved in Canada for use at point-of-care settings. The INSTI(R) is a rapid in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
 membrane-based qualitative test for the detection of antibodies to Human Immunodeficiency Viruses human immunodeficiency virus
n.
HIV.


Human immunodeficiency virus (HIV)
A transmissible retrovirus that causes AIDS in humans.
 Types 1 and 2 in human whole blood, serum or plasma. The test is intended for use by trained personnel in medical facilities, clinical laboratories, and emergency care situations as a point-of-care test capable of providing results in approximately sixty seconds.

The trials were conducted both at point of care locations and at approved provincial laboratories, the results of which are summarized in the table below:
---------------------------------------------------------------------
                Point of Care     Whole Blood    Plasma     Serum
---------------------------------------------------------------------
Sensitivity              99.5 %          99.6 %    99.6 %    99.2 %
---------------------------------------------------------------------
Specificity              99.3 %          99.4 %    99.9 %    99.9 %
---------------------------------------------------------------------
Total number of patients tested                             3,467
---------------------------------------------------------------------
Total number of tests performed                            11,775
---------------------------------------------------------------------


Sensitivity is defined as a measure of the probability of correctly identifying an HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  infected person while specificity is a measure of the probability of correctly identifying a non HIV-infected person. A sensitive test is more unlikely to produce false negatives and a specific test is more unlikely to produce false positives.

The conclusions presented at the Conference indicate that the INSTI(R) HIV-1/HIV-2 Ultra Rapid Antibody Test Kit, used at point of care and laboratory testing sites, was equivalent to the Health Canada approved laboratory test of record, the Abbot AxSym GO, in overall sensitivity, specificity, and the early detection of antibodies. Further, the performance characteristics of INSTI(R) were highly concordant across matching finger-stick, venous whole blood, plasma and serum samples and there existed no lot-to-lot variation in performance. Test results also provided evidence that the INSTI(R) will only work with the addition of adequate amounts of human blood, serum or plasma providing a high degree of patients' safety in validity of results.

Given the test results and conclusions, a dossier will be prepared and presented to Health Canada for the regulatory approval of the INSTI(R). Should approval be granted, INSTI(R) testing will be available to the Canadian public through various health care providers.

"We view the Bangkok AIDS conference as an excellent opportunity to promote the advantages of INSTI(R) to HIV and AIDS health care professionals around the world." said Rene Goehrum, Hedley's Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  from Bangkok. "Given that the INSTI(R) is a point of care diagnostic device, meaning it is administered by trained professionals on site, an early introduction of its merits, advantages and trial results, to the right people, will prove to be beneficial in the fight against the proliferation proliferation /pro·lif·er·a·tion/ (pro-lif?er-a´shun) the reproduction or multiplication of similar forms, especially of cells.prolif´erativeprolif´erous

pro·lif·er·a·tion
n.
 of HIV and AIDS."

In other matters, the Board of Directors of Hedley Technologies Inc. announces that it has authorized the issuance of 30,000 incentive stock options to two directors and one employee. Subject to TSX Venture Exchange TSX Venture Exchange

Originally called the Canadian Venture Exchange (CDNX), this was a result of the merger of the Vancouver and Alberta stock exchanges. The goal of TSX Venture Exchange is to provide venture companies with effective access to capital while protecting investors.
 approval, the options will be subject to the vesting Vesting

The process by which employees accrue non-forfeitable rights over employer contributions that are made to the employee's qualified retirement plan account.

Notes:
 provisions of the company's Stock Option Plan and will be exercisable at $0.17 per share until July 12, 2009.

Hedley Technologies Inc. is a publicly traded life science company that develops, acquires, or commercializes proprietary science-based technologies that advance human health, public safety and the value of agricultural production. Hedley's common shares are listed for trading on the TSX Venture Exchange (TSXV) under the symbol HED.

This press release may contain information or statements that are forward-looking. The contents herein represent our judgment, as at the release date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking information or statements. Potential risks may include, but are not limited to, those associated with clinical trials, product development, future revenue, operations, profitability and obbtaining regulatory approvals.

The TSX Venture Exchange assumes no responsibility for the accuracy of this release and neither approves nor disapproves of same.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jul 12, 2004
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