CURRENT PRESS RELEASES
August 11, 2009
bioLytical PMA Application Accepted For Filing
bioLytical announced today that it has received notification from the U.S. FDA that's application for Pre-Market Approval (“PMA”) for its INSTI™ HIV diagnostic test has been accepted for filing. The PMA has a filing date of June 29, 2009, and is presently under review by the Center for Biologics Evaluation and Research (CBER) of the FDA.
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June 30, 2009
bioLytical elects Michael Weinstein to its Board of Directors
bioLytical announced today that at its Annual General Meeting, shareholders elected Michael Weinstein to the Board of Directors for a three year term. Mr. Weinstein is the President and co-founder of AIDS Healthcare Foundation (“AHF”) and a recognized leader in the fight against HIV/AIDS. bioLytical is pleased to have someone with Mr. Weinstein’s depth of knowledge and relevant market experience on its board. The Company intends to work closely with AHF in its goal to significantly increase rapid testing for HIV/AIDS all over the world.
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June 29, 2009
bioLytical Announces Filing of PMA with FDA for INSTI
bioLytical announced today that it has filed a Premarket Approval (PMA) application with the FDA seeking approval to market its INSTI rapid HIV diagnostic test in the United States. The application will initially be reviewed to ensure that all the required elements have been completed. Upon acceptance of the filing, a more formal review will be commenced by the FDA.
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June 5, 2009
bioLytical Secures 1 Million Test Purchase Commitment From AIDS Healthcare Foundation (“AHF”)
bioLytical announced today that is has secured a 1 million INSTI test purchase commitment from AIDS Healthcare Foundation. AHF is a global non-profit, public benefit organization that has been providing cutting edge medicine and advocacy to those infected by HIV/AIDS for over 20 years. AHF operates in 22 countries and plans to use INSTI at its testing clinics and sites all over the world.
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June 1, 2009
National Research Council Industrial Research Assistance Program (NRC-IRAP) Approves Grant for bioLytical
bioLytical announced today that it has been approved for a IRAP grant to be used towards its research and development of new In Vitro Diagnostic (IVD) products. The grant will allow bioLytical to expand its research and development team and more rapidly bring new products to market. Back to top
Sept. 16, 2008
AKL: Free haircut day to help chop HIV
Aucklanders can get a free haircut along with an HIV test at a special all-day event planned for Saturday 4 October. Over twenty stylists from all over Auckland City are getting involved in The Chop, along with DJs, celebrity guests and drag performers. "The discerning public will be invited to have their hair styled, cut and designed for absolutely free," explains Bain Duigan of Body Positive HIV support network. "To qualify for this free offer an HIV test is offered prior to the haircut." Back to top
May 28, 2008
bioLytical development agenda receives external funding!
Canada’s National Research Council- Industrial Research Assistance Program has
committed
funding over 19 months to develop, test and implement a cost
effective, sensitive and
rapid multiplex assay for the simultaneous detection of three important sexually
transmitted
infections. Additional funding is anticipated from other sources in support of
this international
R&D collaboration.
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May 12, 2008
INSTI one step closer to US market entry!
FDA milestone achieved. The USFDA has set the date for bioLytical’s pre PMA
meeting for
July 14, 2008. The pre PMA is another step in the FDA approval process which is
essential to
receiving the green light for the submission of the formal PMA for the approval
of INSTI in the
US.
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May 12, 2008
INSTI positions to be first line test in Uganda!
bioLytical invited to present INSTI to the Ugandan Minister of Health. In
partnership with the
Aids Healthcare Foundation, bioLytical will meet with Minister Dr. Madraa and
AHF Uganda
Medical Director, Dr. Penny Iutung. The meeting will introduce INSTI for
consideration as the
first line test in the procedure now used in the country. On February 16th 2008
INSTI was
introduced to Uganda by the Aids Healthcare Foundation who tested 1104 people in
a single day.
May 7, 2008
INSTI is perfect in Alberta pilot!
The Alberta Provincial Laboratory has provided an interim report on the use of
INSTI in three
applications: Mother to child transmission, Occupational exposures and patients
in ER with
acute illness. With over 50% of testing completed (N=1,000) INSTI is 100% in
agreement with
lab testing.
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May 5, 2008
bioLytical welcomes Aids Healthcare Foundation to Richmond!
Terri Ford, Director of Global Development and Whitney J. Engeran III toured the
bioLytical
Laboratories automated manufacturing facility and met with the Senior Leadership
team to
discuss common goals and potential points for future collaboration.
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May 1, 2008
Province of Manitoba the second to make INSTI available to those at risk!
Manitoba is the second province in Canada to use INSTI! bioLytical was delighted
to receive a
purchase order from the Province of Manitoba to supply INSTI for the balance of
the fiscal year
ending 31/3/2009. We applaud the leadership demonstrated by the Manitoba
government in
making immediate HIV test results available to their citizens. This type of
progressive public
policy increases the likelihood of identifying the 25-30 % of HIV positive
people who are
unaware of their status.
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April 30, 2008
Ontario ready for full implementation of provincial HIV testing program!
90% of staff from clinics using INSTI in Ontario have been certified through
biolytical program.
The roll out of INSTI in Ontario is nearing completion with the certification of
286 staff that will
now use INSTI in over 60 clinics as part of a province wide program of HIV point
of care
testing. Ontario government representatives report that POC testing in the
province is expected
to grow to 60,000 tests in the next year. Back to top
April 22, 2008
INSTI is perfect in France!
The French Health Products Safety Agency (AFSSAPS) has evaluated 8 different
rapid tests and
INSTI was one of only three tests that achieved 100% performance results. This
positions INSTI
well for the anticipated growth in POC testing in the French market over the
next several years.
April 21, 2008
INSTI approved in Nigeria!
INSTI has received the regulatory approval for sale in Nigeria from National
Agency for Food
and Drug Administration and Control (NAFDAC).
UNAIDS estimates that in Nigeria, around 3.9 percent of adults between ages
15-49 are living
with HIV/AIDS. Although the HIV prevalence is much lower in Nigeria than in
other African
countries such as South Africa and Zambia, the size of Nigeria’s population
(around 135 million)
meant that by the end of 2006, there were an estimated 2,900,000 people infected
with HIV.
Approximately 220,000 people died from AIDS in 2006 alone in Nigeria. (Source
avert.org)
Nigeria is a large market for INSTI in both the private and government sector
and we hope to sell
500,000 tests by mid 2009. Biolytical shall be working closely with various
NGO’s, Nigerian
National Action Committee on AIDS (NACA) and State and Local Action Committees
on AIDS
(SACA and LACA) and key players in the private sector. INSTI can greatly
contribute to
prevention HIV in Nigeria as it is an ideal product for VCT, Mobile VCT, PMTCT
(Prevention
of Mother to Child Transmission) and field locations with minimum clinical
setting since it is
very easy to use and results come in 60 seconds.
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April 18, 2008
Nine new customers and counting!
Pasante Healthcare Ltd., bioLytical’s UK distributor announces nine new
customers to begin the
first quarter of business. bioLytical and Pasante are please to welcome as new
customers:
- Body Positive Manchester.
- MASH (Sex workers project) Manchester.
- Birmingham GU.
- Drug team Surrey.
- HMP Swaleside; Isle of Sheppey (agreed to use; awaiting first order).
- Same Day Doctor North London.
- Darlington GU and Gay advice (agreed to use; awaiting first order).
- PCT Bradford (agreed to use; awaiting first order).
- Bradford GU (agreed to use; awaiting first order).
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April 17, 2008
INSTI soon to assist First Nations communities!
bioLytical invited to present INSTI at important First Nations meeting in
Campbell River B.C.
Rick Galli conducted a four hour workshop/training session for First Nations
nurses and staff
attending the KDC Health’s (Kwakiutl District Council Health) regional national
gathering.
Participants including representatives from the Federal Government of Canada
were trained on
the use of INSTI in their communities. This training was a precursor to the
establishment of
point of care testing programs as a primary strategy for dealing with HIV rates
that are the
highest in Canada.
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April 17, 2008
INSTI ready to be sold in France!
BioLytical signs MOU with distributor in France!
bioLytical and Laboratories Nephrotek enter into an MOU for the distribution of
INSTI in
France. France is expected to expand POC testing as it strengthens prevention
and treatment
services. Both parties are optimistic about the launch of INSTI in the French
market.
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April 16, 2008
INSTI coming soon to British Columbia?
Dr. Mark Gilbert, MD, BC Centre for Disease Control (BCCDC) outlined BC’s plan
for
launching INSTI In the province. At the 2008 Annual Corrections Health Care
Conference he
stated:
- A provincial plan has been developed in partnership with regional
health authorities and
provincial partners. - 20-25 pilot sites have been identified
- Proposal now before the BC government for funding
April 16, 2008
National use of INSTI in corrections begins!
INSTI showcased at 2008 Annual Corrections Health Care Conference. Conference
attended by
representatives from provincial and federal corrections facilities across the
country. The
conclusions of the demonstration project to date are that POC rapid HIV testing
in prisons is:
- Highly feasible
- Highly acceptable
- Highly compatible
- Cost effective
- Should be offered
April 15, 2008
bioLytical moves closer to developing world release of new product!
New INSTI product moves from the Lab into Beta testing. A second generation
INSTI product
has received ethics approval for beta test site evaluation at St. Paul’s
Hospital in Vancouver
Canada. Dr. Michael O’Shaughnessy expressed his confidence that the INSTI
Plus-HIV product
could be available for developing world markets by Q4-08. INSTI Plus-HIV has
been designed
to assist in the identification of HIV positive people in 60 seconds or less by
providing two
discrete HIV results with a single drop of blood. In countries where multiple
rapid tests are
completed INSTI Plus-HIV will provide immediate patient and economic benefits.
INSTI Plus-
HIV has already demonstrated excellent performance when tested using
seroconversion panels.
Beta testing is expected to be completed in June 2008.
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April 15, 2008
INSTI technology attracts US collaborator!
bioLytical explores new product development collaboration. Confidential
discussions are
underway with the University of Maryland’s Institute of Human Virology on the
potential to
leverage the INSTI technology to produce a new disease monitoring product.
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April 2, 2008
Leveraging expertise for new sales!
Toronto’s Hassle Free Clinic trains staff at Manitoba’s largest testing Clinic!
The first clinic in
Canada to use INSTI has been invited to train staff at the 9 Circles clinic in
Winnipeg Manitoba
on the use of INSTI. 9 Circles is the largest and first clinic in the province
of Manitoba to make
HIV test results immediately available to their clients. Testing is expected to
begin immediately
at 9 Circles.
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April 1, 2008
bioLytical moves to protect new antigen product!
BioLytical receives confirmation of International Patent filing for HIV 1&2
antigens.
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March 29, 2008
INSTI records best performance in the US trial!
Results from the US clinical trial of INSTI, which commenced in July, 2007, and
was completed
in November 2007 were released to bioLytical on May 1, 2008 by the US contract
research
organization who conducted the study on behalf of bioLytical. Details of the
study design can be
found on the Clinical Trials.gov website at:
http://clinicaltrials.gov/ct2/show/NCT00514605?term=bioLytical+AND+INSTI&rank=1.
The
overall sensitivity and specificity of INSTI in this clinical trial of 2,500
subjects surpassed those
of the Health Canada clinical trial which led to license of INSTI as a Class IV
Medical Device
approved for point of care use in Canada. The data appears favourable according
to Rick Galli, bioLytical’s Chief Technology Officer but we must now wait to
receive the FDA’s view before drawing any conclusions. This US clinical trial
data will be the
cornerstone of bioLytical’s Pre-Market Assessment application to the FDA for
approval of
INSTI for the US market.
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March 28, 2008
bioLytical moves to protect new product offering!
BioLytical receives confirmation of international Patent filing for INSTI rapid
parallel test.
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March 26, 2008
bioLytical sells in Bulgaria!
Biolytical has recently appointed a distributor for its INSTI HIV 1/2 Rapid
Antibody Test Kit for
Bulgaria. The current incidence of HIV/AIDS in Bulgaria is comparatively low. A
total of 471
HIV-positive patients were recorded till 20 February 2004. Data from recent
years, however,
indicates a trend towards rapid increase in the number of newly registered
cases. According to
the analysis of the current situation, it is still possible to take efficient
measures to limit the
spread of HIV in Bulgaria (Source MoH Bulgaria). We are trying to target the
government sector
in Bulgaria which holds potential for almost 250,000 tests per annum.
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March 17, 2008
bioLytical enters the market in Guatemala!
Biolytical is pleased to announce that it has appointed a distributor in
Guatemala to effectively
market and distribute its product INSTI HIV 1/2 (60 Sec) Rapid Antibody Test
throughout
Guatemala. With first shipment to be sent next month we expect a steady growth
of sales in
Guatemala and expect annual sales revenues around $150,000.
According to WHO Guatemala has a concentrated and accelerating HIV/AIDS epidemic
with an
estimated 38,000 to 130,000 people currently living with HIV/AIDS and a national
prevalence of
HIV infection among adults of about 1%.
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March 14, 2008
INSTI is perfect and the fastest in saving kids!
INSTI is perfect in South African pediatric application! Dr. Gayle Sherman,
Associate
Professor, Department of Molecular Medicine & Hematology, National health
Laboratory
Service & Wits University reports to bioLytical provisional results of her field
study to
discriminate between HIV positive and HIV negative infants born to infected
mothers. In this
first study using a rapid test not a single HIV child of any age was missed. In
preparing this data
for publication she concluded that ‘…INSTI is potentially the best rapid HIV
test for use in early
and late infancy that I have evaluated.”
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March 3, 2008
Intellectual Property strengthened!
BioLytical receives confirmation of Canadian Patent filing for the INSTI rapid
parallel test.
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February 29, 2008
Political support for INSTI!
Montana Congressman Denny Rheberg submits an Appropriation to the US Congress
for
$5,000,000 to enable the L.A. based Aids Healthcare Foundation to purchase INSTI
tests for use
in Africa, Asia and the Caribbean.
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February 16, 2008
Uganda sees the world’s fastest HIV test in action!
The Aids Healthcare Foundation tests 1,104 Ugandans in one day testing clinic in
Masaka. The
country has a 6.6% prevalence of HIV. The clinic results were 13% positive in
Masaka and 10%
in Kampala. The clinic also reported a 2:1 male to female turnout.
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February 14, 2008
INSTI re-launched in INDIA
bioLytical appoints new distributor for India. Immunoshop India Private Ltd. (Immunoshop)
has
been appointed the exclusive distributor for INSTI in the private sector. See
attached media
release.
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February 13, 2008
bioLytical’s proposal for international R&D collaboration short listed for funding!
This proposal to develop, test and implement a cost effective, sensitive and
rapid multiplex assay
for the simultaneous detection of three important sexually transmitted
infections is expected to
be funded by Q208.
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February 5, 2008
Product interest already hot in the USA
bioLytical leverages intense interest in INSTI from potential American customers
attending the
CDC Atlanta’s HIV Diagnostics Conference December 5-7, 2007. Rick Galli meets
with
clinicians from three large agencies buying large volumes of rapid tests who
agree to “investigate
the use of INSTI” prior to the FDA approval. Their commitments are the beginning
of an
aggressive pre-sales initiative which will expand to other clinical trial sites
and testing agencies
in large markets.
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February 1, 2008
bioLytical builds capacity for US market entry.
To assist in planning for and successfully executing their strategy for
aggressive US market entry
bioLytical has retained O’Neill and Associates (Boston) for Public Affairs
expertise. Since first
meeting Thomas P O’Neill I knew that our plans to create a legacy in rapid HIV
testing with
INSTI would add to his legacy in government and public relations said Carl Roy
bioLytical
President and CEO.
bioLytical has also established a relationship with Wash branding and
communications (LA)
who have prepared a trade communications strategy for the launch of INSTI in
America.
January 12, 2008
Partnership serves the world!
The Aids Healthcare Foundation and bioLytical reach agreement to collaborate to
expand rapid
testing in specific countries in the developing world. The first testing day
will happen in Uganda
followed by a second in India.
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January 10, 2008
bioLytical invited to meet with Quebec Advisory Committee!
The Province of Quebec has invited Carl Roy to Montreal to meet with the
Advisory Committee
on HIV Screening. This twelve member group involves all the key decision makers
in HIV
testing, service and policy and has been created to advise the government on the
best approach to
HIV screening. Three hours have been scheduled to:
- Demonstrate INSTI
- Present product options and Quality Control processes
- Provide update on the rest of Canada’s testing platform for POC testing.
- Summarize results of field testing in Ontario over the past year (Hassle Free Clinic Data).
- Review the Ontario provincial program model and roll out (Point of Care
Testing).
Product use elsewhere in Canada and the Rest of the World. - Overview of recent applications of INSTI in clinics, how the test is being
used, feedback
and testimonials demonstrate INSTI, present how and where it is being used in Canada
and the World and - To discuss implementation issues.
The Committee is expected to table its recommendations for consideration by
government in the spring. Back to top
Dec 4, 2007
December 4, 2007 – Test your Commitment (TYC) is a revolutionary public awareness and mobile testing campaign that provides the public with access to live demonstrations of INSTI™, the only Health Canada approved diagnostic kit for point-of-care testing that delivers HIV results in 60-seconds. Back to top
Nov 29, 2007
The manufacturer of a new rapid HIV test wants the Quebec government to make the device available throughout the province.
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Nov 26, 2007
PRESS CONFERENCE INFORMATION:
A press conference will take place Thursday, November 29th, at 10:00 am, 3535 Boulevard St. Laurent. Back to top
Nov 12, 2007
On November 12th, bioLytical Laboratories celebrated Midnight Magic, and amazing evening with Sir Richard Branson, Elvis Costello, Chriss Angel, and Ms. Dita Von Tesse. Back to top
Nov 7, 2007
Groundbreaking HIV/AIDS Public Awareness and Mobile Testing Campaign Will Visit Toronto and Montreal
VANCOUVER, BC, November 7, 2007 – bioLytical Laboratories Inc. (bioLytical) today announced the Test Your Commitment (TYC) campaign will visit Montreal November 28-29 and Toronto December 6-7.
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Oct 16, 2007
FOR IMMEDIATE RELEASE:
VANCOUVER, BC, October 16, 2007 – bioLytical Laboratories (bioLytical) today announced patient enrolment has exceeded 30% in their Investigational Device Exemption (IDE) study for approval by the U.S. Food and Drug Administration (FDA) of INSTI™, a 60-second rapid HIV test for point-of-care (POC) testing. bioLytical’s IDE filing was accepted by the FDA July 6, 2007.
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Sept 27, 2007
Douglas Boyce / Xtra / Thursday, September 27, 2007:
The Ontario government has chosen the Insti HIV-1 Rapid Antibody Test produced by Richmond, BC-based Biolytical Laboratories for use in Ontario's newly expanded network of anonymous testing facilities. Back to top
Sept 20, 2007
VANCOUVER, BC, September 20, 2007 - British Columbia-based bioLytical Laboratories (bioLytical), the manufacturer’s of the only Health Canada approved rapid HIV test for point-of-care testing, issued a statement today in support of the Manitoba government announcing more than $1.3 million in new spending on anonymous testing, prevention and treatment initiatives for HIV and STIs (sexually transmitted infections). Back to top
Sept 11, 2007
Richmond News - Brett Beadle/ Richmond News:
Richmond company's new instant HIV test is the latest weapon in the war on the disease that kills one child every minute.
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Aug 27, 2007
FOR IMMEDIATE RELEASE:
VANCOUVER, BC, August 27, 2007 – bioLytical Laboratories (bioLytical) announced today that it has signed an agreement with Ontario to supply rapid HIV tests for the province’s anonymous and sexual health clinics. Back to top
Aug 17, 2007
FOR IMMEDIATE RELEASE: VANCOUVER, BC, August 17, 2007 – bioLytical announced today the postponement of the Toronto dates for the Test Your Commitment campaign. Back to top
Aug 13, 2007
FOR IMMEDIATE RELEASE: VANCOUVER, BC, August 13, 2007 – bioLytical Laboratories Inc. (bioLytical) announced today they will participate in a South American trade mission initiated by the Montana World Trade Center (MWTC) at The University of Montana.
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Aug 9, 2007
FOR IMMEDIATE RELEASE:
VANCOUVER, BC, August 9, 2007 – bioLytical today announced the added support of the BC Persons with AIDS Society and AIDS Vancouver for the inaugural Test Your Commitment Campaign. Back to top
Aug 7, 2007
FOR IMMEDIATE RELEASE:
VANCOUVER, BC, August 7, 2007 – bioLytical Laboratories (bioLytical) announced today that it has received final licensing approval for the INSTI™ kit in Venezuela and Mexico. Back to top
July 31, 2007
VANCOUVER, BC, July 31, 2007 – bioLytical Laboratories (bioLytical) today announced the first 25 patients have been enrolled in their Investigational Device Exemption (IDE) study for approval by the U.S. Food and Drug Administration (FDA) of INSTI™, a 60-second rapid HIV test for point-of-care (POC) testing. Back to top
July 27, 2007
Sandra Thomas, Vancouver Courier -
Published: Friday, July 27, 2007:
Visitors to the Vancouver Art Gallery next month can combine their love of Monet and Dali with advanced medical testing.
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July 16, 2007
FOR IMMEDIATE RELEASE:
Vancouver,BC, July 16, 2007 – bioLytical™ Laboratories is proud to announce that Virgin Mobile Canada will be sponsoring the Test Your Commitment campaign this August. Back to top
July 10, 2007
VANCOUVER, BC, July 10, 2007 – bioLytical Laboratories (bioLytical) announced today the U.S. Food and Drug Administration (FDA) has accepted the Investigational Device Exemption (IDE) application for INSTI™, a 60-second rapid HIV test for point-of-care testing. Back to top
June 29, 2007
John Bermingham, The Province -
Published: Friday, June 29, 2007:
A Vancouver company is taking its 60-second HIV test to the streets. Back to top
June 28, 2007
Groundbreaking HIV/AIDS Public Awareness and Education Campaign, Including Free 60-Second HIV/AIDS Tests, to Hit Vancouver, Toronto, Montreal Streets This August Back to top
June 23, 2007
KEITH LESLIE -
Canadian Press: TORONTO -- Ontario has become the first jurisdiction in North America to offer HIV tests that provide results in just 60 seconds and will double the number of sites across the province where anonymous tests are available, Health Minister George Smitherman announced yesterday.
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June 22, 2007
Vancouver, BC, Canada June 22, 2007: British Columbia-based bioLytical Laboratories (bioLytical), the manufacturer’s of the only Health Canada approved rapid HIV test for point-of-care testing issued a statement today in support of Ontario Health Minister George Smitherman’s announcement on the launch of the first HIV testing program in Canada that gives results in 60 seconds.
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May 30, 2007
Vancouver, BC, Canada May 30, 2007: In partnership with community and Delhi State Aids Control Society (DSACS), bioLytical Laboratories (bioLytical) organized a two-day campaign raising awareness of HIV/AIDS in India and testing more than 500 people.
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May 18, 2007
In partnership with governmental and community organizations in Delhi, India, bioLyticalTM Laboratories (bioLytical) will train over 350 health care workers on how to administer the INSTITM 60 second HIV test. Back to top
May 10, 2007
VANCOUVER, CANADA (May 10, 2007) – bioLyticalTM Laboratories (bioLytical) is pleased to announce it has been cited by the BC Medical Association (BCMA) as the only manufacturer in Canada with a Health Canada approved point-of-care (POC) HIV test.
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April 30, 2007
VANCOUVER, CANADA (April 30, 2007) – bioLyticalTM Laboratories (‘bioLyticalTM) is pleased to announce the appointment of Mr. Carl F. Roy to the position of President and CEO. Back to top
Mar 21, 2007
March 21, 2007 - bioLytical Europe is pleased to announce that they have just received final registration for the INSTI kit in the country of Poland. Back to top

