August 11, 2009

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. Back to top

June 30, 2009

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. Back to top

June 29, 2009

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. Back to top

June 5, 2009

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. Back to top

June 1, 2009

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

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

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.   Back to top

 

May 12, 2008

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.   Back to top

 

May 12, 2008

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.  

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May 7, 2008

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.   Back to top

 

May 5, 2008

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.   Back to top

 

May 1, 2008

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.   Back to top

 

April 30, 2008

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

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.  

Back to top

 

April 21, 2008

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.   Back to top

 

April 18, 2008

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).   Back to top
  
  

 

April 17, 2008

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.   Back to top

 

April 17, 2008

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.   Back to top

 

April 16, 2008

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

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April 16, 2008

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

 Back to top

 

April 15, 2008

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.   Back to top

 

April 15, 2008

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.   Back to top

 

April 2, 2008

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.   Back to top

 

April 1, 2008

BioLytical receives confirmation of International Patent filing for HIV 1&2 antigens.   Back to top

 

March 29, 2008

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.   Back to top

 

March 28, 2008

BioLytical receives confirmation of international Patent filing for INSTI rapid parallel test.   Back to top

 

March 26, 2008

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.   Back to top

 

March 17, 2008

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%.   Back to top

 

March 14, 2008

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.”   Back to top

 

March 3, 2008

BioLytical receives confirmation of Canadian Patent filing for the INSTI rapid parallel test.   Back to top

 

February 29, 2008

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.   Back to top

 

February 16, 2008

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.   Back to top

 

February 14, 2008

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.   Back to top

 

February 13, 2008

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.   Back to top

 

February 5, 2008

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.   Back to top

 

February 1, 2008

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.  

Back to top

 

January 12, 2008

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.   Back to top

 

January 10, 2008

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.   Back to top

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

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.   Back to top

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.    Back to top

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.   Back to top

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.   Back to top

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.   Back to top

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.   Back to top

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.   Back to top

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.    Back to top

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.   Back to top

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

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