December 1, 2011 | PRINT VERSION (PDF)

Surrey, CANADA – Canadian life sciences firm bioLytical Laboratories is uniting with the global community in the fight against HIV/AIDS on this 23rd anniversary of the World AIDS Day. Based on the theme ‘Getting to Zero,’ the focus for this year’s World AIDS Day is on achieving three critical targets: Zero new HIV infections. Zero discrimination. Zero AIDS-related deaths.

As the developer of the INSTI™ Rapid Antibody Test, the world’s only 60-second antibody detection test, bioLytical Laboratories can play a key role in achieving these targets.

“INSTI™ is an important testing innovation to support ‘Getting to Zero’,” says Colin MacGillivray, Chief Operating Officer & CFO of bioLytical Laboratories. “A number of programs in Africa, Europe and Canada have adopted INSTI™ as a first line test because its speed and ease of use make it possible to achieve the ambitious but necessary testing goals now established in these jurisdictions. As part of our commitment to eradicating this disease we’re also working to extend access to our technology into a wider range of settings within the U.S. and other territories.”

The company has played a key role in improving accessibility and efficiency of HIV testing, contributing both to the diagnosis of HIV positive patients, and the process of preventing the spread of infection to others. INSTI™ is ultimately making the treatment and prevention of HIV/AIDS a more attainable, and cost-effective goal for patients and their health care providers, particularly in hard-to-reach, and high-risk populations.

INSTI™’s speed and ease-of-use not only allow many more tests to be administered quickly, but its ability to provide patients with nearly instantaneous results also enable more efficient and effective early identification of HIV in diverse patient settings, from hospital emergency rooms to public health clinics.

World AIDS Day is held on December 1st each year and is an opportunity for people worldwide to unite in the fight against HIV, show their support for people living with HIV and to commemorate people who have died. World AIDS Day was the first ever global health day and the first one was held in 1988.

For more information, call bioLytical™ at 888-316-0351 or visit www.biolytical.com.

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Rebecca Peters
Laura Ballance Media Group
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November 10th 2011 | PRINT VERSION (PDF)

Surrey, CANADA – As developer of the INSTI™ Rapid HIV Test, bioLytical Laboratories plays an important role in British Columbia’s landmark “Seek and Treat” pilot project, which recently ramped up across the province.

Promotion of BC’s “Seek and Treat” pilot project expanded this week with a guerilla marketing campaign initiated by Vancouver Coastal Health Authority and delivered via social media, bus shelters and websites. About 200,000 HIV tests are completed annually in B.C. and such blood tests have detected nearly 14,000 cases of individuals now living with HIV. Last year, there were 301 new HIV cases in B.C.; three of every 1,000 tests result in an HIV diagnosis. British research has demonstrated a cost benefit when the prevalence of diagnosis is one or two out of every 1,000 tests.

The four-year, $48-million program, funded by the provincial government, is currently underway in Prince George and Vancouver. It’s meant to identify up to 3,500 more cases of HIV; the number of adults estimated to be unknowingly infected with the virus in B.C.

Under the program, family doctors are being urged to add on HIV testing for all adult patients being sent for other types of blood tests. “The INSTI™ Kit is able to detect HIV antibodies in just 60 seconds or less,” says bioLytical Chief Technical Officer Rick Galli.

“The speed to result and ease of use provided by INSTI™ will allow B.C. to administer more tests in a wider variety of settings and to do so in a manner that leverages financial and human resources very efficiently,” says bioLytical Chief Operating Officer & CFO Colin MacGillivray.

Since developing the INSTI™ Kit, bioLytical has played a key role in improving accessibility and efficiency of HIV testing across Canada and in other countries around the world, ultimately making the treatment and prevention of HIV/AIDS a more attainable, and cost-effective goal for patients and their health care providers, particularly in hard-to-reach, and high-risk communities.

Significant resources have been spent developing the INSTI™ test and bringing it to the marketplace. bioLytical is committed to working with key stakeholders to improve access to its technology.

For more information, call bioLytical™ at 888-316-0351 or visit www.biolytical.com.

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Media Contact
Rebecca Peters
Laura Ballance Media Group
604.637.6649 (direct)
604.762.2098 (mobile)
Rebecca@LBMG.ca

October 28th 2011 | PRINT VERSION (PDF)

Surrey, CANADA – In a show of support for the world leading HIV/AIDS research being undertaken in British Columbia, Canada, Canadian life sciences firm bioLytical Laboratories has pledged financial support for the Second International Workshop on HIV Treatment as Prevention.

The Workshop, to be held in Vancouver, British Columbia April 22nd – 25th 2012, will bring academic, policy, industry, and community representatives together to review new data and to identify priority areas for research and action related to the impact of combination antiretroviral therapy (ART) use among HIV infected individuals on the transmission of HIV infection. The event will serve as a focal point for researchers involved in Treatment as Prevention to share data, protocols and findings, and to foster an open collaborative environment regarding this important research.

“I very much appreciate the support of bioLytical,” commented a pioneer of the Treatment as Prevention strategy, Professor Julio Montaner, Director of the BC Centre for Excellence in HIV/AIDS and the St. Paul’s Hospital Foundation Chair in AIDS Research Professor of Medicine, at the University of British Columbia.

“For the second year we are delighted to pledge our support for this important conference. The Treatment as Prevention strategy can produce long-term and transformative results for the treatment and prevention of HIV/AIDS” said Colin MacGillivray, Chief Operating Officer & CFO, bioLytical Laboratories. “We are very pleased that so many key players from around the world will gather and collaborate in British Columbia where the Treatment as Prevention strategy was pioneered and which is also the home province of biolytical.“

bioLytical Laboratories is the maker of the INSTI™ rapid HIV Antibody test, which is able to detect HIV antibodies in just one minute. Ease of use and speed to result allow many more tests to be administered and people to find out their results almost instantaneously.

First commercialized in 2006, the INSTI™ rapid HIV Antibody test has been extensively field-tested and is the only point-of-care rapid HIV Antibody test approved by Health Canada. INSTI also has European CE mark approval, and recently received U.S. Food and Drug Administration (FDA) approval.

Over two million INSTI™ tests have been conducted worldwide, and the test is an essential component of the $48 million, cutting-edge STOP HIV/AIDS pilot announced in British Columbia last year.

For more information, call bioLytical™ at 888-316-0351 or visit www.biolytical.com.

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Media Contact
Rebecca Peters
Laura Ballance Media Group
604.637.6649 (direct)
604.762.2098 (mobile)
Rebecca@LBMG.ca

October 25th 2011 | PRINT VERSION (PDF)

Surrey, CANADA – Canadian life sciences firm bioLytical Laboratories is marking the milestone 6th anniversary of the approval of its INSTI™ Test in the Canadian market. Increasingly recognized as the fastest diagnostic HIV test in the world, the INSTI™ HIV Antibody Rapid Test Kit, first introduced in Ontario, has now been adopted by provinces across Canada, evidence of significant progress in the diagnosis and treatment of HIV/AIDS in Canada.

To date, INSTI™ is the only rapid in vitro qualitative test approved in Canada for the detection of antibodies to HIV in human whole blood, finger-stick blood, serum or plasma specimens. By utilizing innovative flow-through technology, INSTI™ is able to generate accurate results in as little as 60 seconds. INSTI™’s speed and ease-of-use not only allow many more tests to be administered, but its ability to provide patients with nearly instantaneous results also enable more efficient and effective early treatment of HIV/AIDS in diverse patient settings, from hospital emergency rooms to public health clinics.

“In this year of our sixth anniversary since approval by Health Canada, the broader adoption of INSTI™ by British Columbia as part of the STOP HIV/AIDS pilot represents significant, continued progress in HIV testing in Canada,” says Rick Galli, Chief Technical Officer, bioLytical Laboratories. “bioLytical is proud to see this innovative, locally developed solution now making a real difference within British Columbia and more widely across Canada and in many other countries around the world,” adds Colin MacGillivray, bioLytical Chief Operating Officer and CFO.

INSTI™ utilizes just three reagents in ready-to-use test vials, and incorporates a unique, built-in human IgG-capture control feature to ensure the proper sample addition and test validity. This has the potential to eliminate the need for more costly and time-consuming tests currently available on the market, making access, availability, and efficiency more attainable goals for health care providers, especially within hard-to-reach and high-risk communities.

The simplicity of INSTI™’s procedure, which entirely removes the need for counting drops, measuring, or timing, and eliminates the need for refrigeration has helped to broaden adoption of HIV testing. Increased continuity of pre- and post-test counselling has also significantly improved patient prevention and treatment education and the patient’s overall clinical experiences since administering the test and obtaining results can be completed so quickly.

For more information, call bioLytical™ at 888-316-0351 or visit www.biolytical.com.

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Media Contact
Rebecca Peters
Laura Ballance Media Group
604.637.6649 (direct)
604.762.2098 (mobile)
Rebecca@LBMG.ca

October 8th 2011 | PRINT VERSION (PDF)

Surrey, CANADA – Canadian life sciences firm bioLytical Laboratories is currently working to increase the availability of the firm’s INSTI™ HIV Rapid Antibody Test, which is able to detect HIV antibodies in just one minute.

“Ease of use and speed to result allow many more tests to be administered and people to find out their results almost instantaneously,” says bioLytical Chief Technical Officer Rick Galli. “We are committed to increasing access to our test. It’s our belief that rapid testing leads to earlier detection which leads to better outcomes and ultimately reduces the spread of the virus.”

“Ultimately we think African countries plagued by this devastating disease could benefit from a similar program to that which is being piloted here in British Columbia. ‘Test and Treat’ involves finding and treating high-risk individuals who are undiagnosed or untreated for HIV,” says Galli.

‘Test and Treat’ aims to increase HIV testing and expand access to medications among hard-to-reach populations to significantly reduce or eliminate the virus’s ability to spread. The INSTI™ test, the first of its kind in the world, is an integral part of the ‘seek’ or ‘test’ element of the program, as the test can be given in a wide variety of settings, producing instant, accurate results.

Having recently returned from a trip to the African countries of Uganda, Zambia and Kenya, Vice President, Business Development Lesley Schopp says, “It’s clear that incorporation of INSTI™ technology into national testing algorithms could play an important role in extending the success of testing programs, an important first step in linking patients to care and reducing the spread of the virus.”

In the urban areas of Zambia, such as the Copperbelt and Lusaka, as many as 25% of people are HIV positive. Women and girls are especially vulnerable to the epidemic: at the end of 2006, 57% of the adults living with HIV in Zambia were women.

In Nairobi, Kenya, about 7% of all adults (ages 15-49) are HIV positive and in some areas the rates are closer to 15%. While the epidemic affects every segment of the population, Kenya’s 2009 modes of transmission analysis found that new infections were most likely to occur between heterosexual partners in steady relationships.

Significant resources have been spent developing the INSTI™ test and bringing it to the marketplace. bioLytical is committed to working with key stakeholders to improve access to its technology.

For more information, call bioLytical™ at 888-316-0351 or visit www.biolytical.com.

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Media Contact
Rebecca Peters
Laura Ballance Media Group
604.637.6649 (direct)
604.762.2098 (mobile)
Rebecca@LBMG.ca

June 6th 2011 | PRINT VERSION (PDF)

Surrey, CANADA – Thirty years after the first reported cases of AIDS in the United States, the research and development carried out by Canadian life sciences firm bioLytical Laboratories represents an important contribution to addressing the HIV/AIDS epidemic.

The alarming speed with which AIDS spread to and claimed countless lives when it was first identified in 1981, proved devastating for the international community – not least because of its struggle to find a solution. Over the past three decades, however, a remarkable amount of research has resulted in significant gains in the prevention and treatment of HIV/AIDS. Thanks to a global commitment to eradicate this devastating disease, millions of lives have been saved while millions more have been transformed.

As the developer of the INSTI™ HIV Antibody Test, the world’s only 60-second antibody detection test, recognized as the fastest diagnostic HIV test in the world, bioLytical Laboratories has contributed both to the diagnosis of HIV positive patients, and the process of preventing the spread of infection to others.

The company has played a key role in improving accessibility and efficiency of HIV testing across Canada and in other countries around the world, ultimately making the treatment and prevention of HIV/AIDS a more attainable, and cost-effective goal for patients and their health care providers, particularly in hard-to-reach, and high-risk communities.

“The 30th anniversary is a significant milestone in HIV/AIDS awareness and research, and it’s important to recognize how far we’ve come in terms of treatment, education, and prevention since AIDS was first diagnosed,” says Rick Galli, Chief Technical Officer of bioLytical Laboratories. “However, there is a long way to go. INSTI™ can extend the reach and productivity of existing testing programs and thus enhance HIV detection and prevention.”

 To date, bioLytical’s revolutionary INSTI™ rapid HIV Antibody test is the only point-of-care rapid HIV Antibody test approved by Health Canada. It continues to transform the face of HIV/AIDS awareness across the globe, and remains an important tool in international efforts to eradicate the disease, especially in light of the encouraging results of the HPTN 052 clinical trial, which suggests that early diagnosis and treatment of HIV patients significantly reduces their likelihood of transmitting the virus.

For more information, call bioLytical™ at 888-316-0351 or visit www.biolytical.com.

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Media Contact
Rebecca Peters
Laura Ballance Media Group
604.637.6649 (direct)
604.762.2098 (mobile)
Rebecca@LBMG.ca

May 13th 2011 | PRINT VERSION (PDF)

Surrey, CANADA – Canadian life sciences firm bioLytical Laboratories is praising researchers who worked tirelessly on a landmark study whose findings scientists say could help stem the global AIDS pandemic.

The results of the HPTN 052, a randomized, phase 3 clinical trial, show that early HIV treatment not only benefits the person with HIV/AIDS, but also dramatically reduces the likelihood that he or she will transmit the virus to sexual partners.

Termed “treatment as prevention” this approach adds to the growing range of prevention and treatment options that, used in concert, many believe could help eradicate the disease, which has plagued the world for more than three decades.

bioLytical Chief Technical Officer Rick Galli says, “This combination of new and emerging HIV prevention methods provides us with hope that experts can dramatically constrict the flood of new infections. We’re incredibly optimistic that bioLytical’s INSTI™ Rapid HIV Antibody Test will play a significant role in the treatment as prevention approach and we’re excited to continue down this progressive path with other experts in the field.”

The INSTI™ HIV Rapid Antibody Test is able to detect HIV antibodies in just 60 seconds or less. Ease of use and speed to result allow many more tests to be administered and people to find out their results almost instantaneously.

“It is estimated that up to 80% of the people infected with HIV in developing countries do not know they are infected. If those individuals were diagnosed, this would have a dramatic effect on slowing the spread of the disease.” commented bioLytical Board Chairman Robert Mackie.

In 2009, 2.6 million people were newly infected with HIV, according to United Nations estimates. More than 33 million people are estimated to have HIV worldwide.

For more information, call bioLytical™ at 888-316-0351 or visit www.biolytical.com.

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Media Contact
Rebecca Peters
Laura Ballance Media Group
604.637.6649 (direct)
604.762.2098 (mobile)
Rebecca@LBMG.ca

December 1, 2010

Innovative screening assay detects antibodies to HIV in as little as 60 seconds

VANCOUVER, BRITISH COLUMBIA; CHICAGO, December 1, 2010 — bioLytical Laboratories announced today, recognized globally as World AIDS Day, that it has received U.S. Food and Drug Administration (FDA) approval to market its INSTI™ rapid HIV antibody test in the United States. INSTI™ is the first new rapid HIV test approved by the FDA through its Premarket Approval (PMA) process for point-of- care use in nearly five years. Unlike currently available lateral-flow technology, which requires approximately 15 to 30 minutes to generate results, INSTI utilizes flow-through technology, which produces results in as little as 60 seconds.

The FDA approved INSTI™ for the detection of antibodies to HIV-1 in whole blood, finger stick blood, or plasma specimens. U.S. clinical trial data showed minimum sensitivity and specificity of 99.8% and 99.5% respectively, in finger stick, venipuncture blood and plasma samples. bioLytical™ is seeking approval for HIV-2 in the U.S via PMA supplement.

INSTI™ includes a unique antigen construct comprised of recombinant proteins for HIV-1 (gp-41) and HIV-2 (gp-36). “These unique antigens ensure that the test will be a critical addition to any rapid testing algorithm,” said Rick Galli, bioLytical™ chief technical officer. As with all rapid HIV tests, positive results are considered preliminary and must be confirmed before establishing a diagnosis of HIV infection.

“The unique antigen is important because the HIV testing community appears to be headed toward a multi-rapid test algorithm, eliminating the need for the more costly and time-consuming Western Blot and Indirect Fluorescent Antibody (IFA) tests,” said Niel Constantine, Ph.D., professor of pathology, University of Maryland School of Medicine Institute of Human Virology, an INSTI clinical trial investigator. “Using a multi-test rapid algorithm, we must deploy tests with different antigens, so bioLytical™’s use of a unique antigen satisfies that requirement. And since INSTI™ also utilizes a novel flow-through technology, it would be a strong addition to a rapid/rapid algorithm."

INSTI™ also includes a unique, enhanced procedural control, utilizing a true human IgG sample addition feature. The test will only react when the correct quantity of human blood is added, reducing user error that can lead to inaccurate results. The test is highly stable and does not require refrigeration or specialized storage.

“We believe the speed, accuracy, and unique technology of our 60-second HIV test will make the testing and early treatment of HIV/AIDS more efficient in all patient settings, including hospital emergency rooms and public health clinics,” said bioLytical™ Laboratories President Philip Bligh. “Additionally, our high-volume, automated manufacturing capability makes INSTI™ one of the most cost-effective solutions available for providers of HIV rapid testing.”

“A rapid, accurate, sufficiently sensitive and inexpensive field testing kit for HIV has been needed for a long time,” said Robert Gallo, M.D., a co-discoverer of the Human Immunodeficiency Virus, a world leader in HIV/AIDS research, and currently the director of the Institute of Human Virology at the University of Maryland School of Medicine. “The Institute for Human Virology would be willing to collaborate with bioLytical™ to explore the use of the product in novel settings worldwide and in the USA by providing both the population and expertise necessary.”

First commercialized in 2006, the INSTI™ rapid HIV test has been extensively field-tested and is the only point-of-care rapid HIV test approved by Health Canada. INSTI also has European CE mark approval, and is on the USAID PEPFAR waiver list. In time for World AIDS Day, the U.S. joins 56 other countries where INSTI is available to screen for HIV. Those who have worked so hard to combat the virus in the U.S. now have an important new tool. Additionally, nearly two million tests have been conducted worldwide, and the test is an essential component of the $48 million, cutting-edge Seek and Treat pilot announced in British Columbia, Canada earlier this year.

Jane Greer, administrator of the Hassle Free Clinic in the greater Toronto area noted, “INSTI™ represents a huge step forward in our fight against HIV/AIDS. We have been deploying INSTI™ for HIV screening since 2006 and have found it easy to use. It has improved the quality of our testing program, and has increased our testing throughput. INSTI™ has been tremendously beneficial for clients, allowing all clients to obtain virtually immediate results, which encourages testing and reduces client anxiety. Additionally, by combining pre and post-test counseling into one visit, INSTI™ has increased our capacity to provide HIV testing to more patients.”

INSTI™ has been extensively studied, spending more than two years in clinical trials with Health Canada and FDA, comprising over 16,000 tests with matching finger stick blood, venipuncture blood, plasma and serum on more than 6,000 patients. bioLytical is currently applying for CLIA-waived status for INSTI. For more information on INSTI™, call bioLytical™ at 888-316-0351 or visit www.biolytical.com.

Testing for HIV/AIDS in the United States

In July, the Obama administration announced its national strategy on HIV, which calls for reducing the rate of new HIV infections by 25 percent over the next five years. Widespread testing and early diagnosis are critical to reducing the rate of new infections. The FDA approval of INSTI™ will allow patients to be diagnosed more quickly than ever before and will allow for testing in novel settings.

“With just two reagents, INSTI™ is very easy to perform, and its major advantage is speed,” Dr. Constantine said. “You might find some physician offices now adopting HIV testing since they can now perform the test and obtain results so quickly. The convenience of waiting only one minute compared to waiting 20 minutes is more desirable for both the patient and the physician.”

INSTI™’s speed allows HIV testing programs to be implemented in key high-prevalence / high-volume settings with minimal interruption of current workflows. It allows testing and counseling processes to fit more easily into many complex environments, particularly correctional settings and emergency rooms.

Public health officials have advocated for making HIV testing more widely accessible as increasing the number of people who know their status may be the most effective way to curb the spread of HIV/AIDS. It is widely accepted that when people are aware of their HIV status, they may be less likely to engage in risky behaviors and pass on the virus. Additionally, when HIV positive people are on antiretroviral therapy and have undetectable levels of the virus, their ability to transmit the virus may be significantly reduced.

According to Julie Scofield, executive director of the National Alliance of State and Territorial AIDS Directors (NASTAD), “INSTI™ represents a significant improvement for point-of-care rapid HIV testing. By eliminating the 15- to 30-minute wait for results, INSTI™ streamlines the testing process. It allows for increased flexibility as providers can conduct the test in whatever manner best suits their workflow process.”

The Premarket Approval Process (PMA)

As described on www.fda.gov, “PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by FDA. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).”

About bioLytical™ Laboratories

bioLytical™ Laboratories is a leading developer and manufacturer of rapid, point of care diagnostic assays. bioLytical™ is a privately owned, federally incorporated Canadian company based in Vancouver, British Colombia with offices in Chicago. The company’s INSTI™ test platform utilizes flow-through technology, which produces near instantaneous results. The platform also provides for multiplex testing capabilities, which means that rapid testing for more than one infectious disease can be conducted using one finger stick sample. bioLytical is the exclusive manufacturer of the INSTI™ HIV Rapid Test kit. The company’s fully automated 20,000 sq. ft. production facility is ISO 9001 and 13485 accredited and GMP compliant.

For more information, call bioLytical™ at 888-316-0351 or visit www.biolytical.com.

 

Media Contact
Rebecca Peters
Laura Ballance Media Group
604.637.6649 (direct)
604.762.2098 (mobile)
Rebecca@LBMG.ca

November 29, 2010

bioLytical™ is preparing for it’s international World AIDS Day initiatives, partnering with AIDS Healthcare Foundation. bioLytical™ has shipped test kits all over the world including Mexico, India, Venezuela, Uganda, Sierra Leone, South Africa and Zambia in anticipation for AHF’s large testing events. In 2009, AHF’s “Testing Millions” campaign was a groundbreaking global effort to test millions of people for HIV as part of a global testing campaign tied to the observance of World AIDS Day on December 1st. The impressive results of the 2009 campaign demonstrate what can be achieved by using new streamlined HIV testing methods. The extreme speed of the INSTI™ test is an integral part of AHF’s novel high throughput testing programs; achieving test results in 60 seconds or less rather than in 20 minutes allows AHF and their partners to test many more people with far fewer testing staff increasing the number of people internationally who learn their status and get into care. Back to top

August 10, 2010

INSTI™ has been selected to be first line on Zimbabwe’s national testing algorithm. The test will be the lead test in the country’s “Know Your Status” program, which will involve mass testing campaigns to take place throughout the country between now and the end of 2011. bioLytical™ is pleased to participate in the program and believes it will serve to further validate INSTI™ as the premier product for use in high volume testing initiatives on the continent. Back to top

March 3, 2010

United Kingdom pharmacy chain Superdrug made INSTI™ available in their in-store pharmacy clinics. Nurses will administer private, walk-in testing at six stores in Brighton, Edinburgh, Croydon, Cardiff, Newcastle and Manchester. Patients with reactive results will be referred to an NHS specialist for care. INSTI™’s speed and accuracy make it the optimal product for use in a pharmacy setting. Patients are able to get their HIV results immediately, without experiencing delay in administration or processing time. This compares to using a free NHS sexual health clinic in which it can take weeks for a patient to get their results. The National Aids Trust welcomed the Superdrug move, saying: "If someone gets diagnosed early they can live a long, active life with HIV. But if they delay, they can become very ill and put their partners at risk too." The program has been so well received that Superdrug has launched the INSTI™ program at 7 additional store locations. Back to top

February 10, 2010

British Columbia has announced a $48 million pilot project to find and treat high-risk individuals who are undiagnosed or untreated for HIV in Prince George and Vancouver’s Downtown Eastside. The four-year program is called “Seek and Treat,” has been hailed as the first of its kind in Canada and is believed to be the first internationally. The program aims to increase HIV testing and expand access to medications among hard-to-reach populations to significantly reduce or eliminate the virus’s ability to spread. The BC Centre for Excellence in HIV/AIDS has shown that treating people with HIV in a jurisdiction can dramatically decrease the transmission rates of HIV. This is important as it helps provide confirmation of bioLytical’s strategy – rapid testing leads to earlier detection which leads to better outcomes and ultimately reduces the spread of the virus. The INSTI™ test will be an integral part of the “seek” element of the program, as test can be administered in a wide variety field settings producing instant, accurate results. This announcement follows the December 2009 announcement from Saskatchewan stating that commencing in 2010 the INSTI™ test will be available in six health regions within the province. As more provinces adopt rapid testing, INSTI™ will become a central part of these programs. 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 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

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