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bioLytical Laboratories Inc. Donates Tests to Help Boost International Testing Access Ahead of International Testing Week

  • bioLytical, in partnership with NGO Coalition PLUS, has donated over 8,000 rapid tests across 25 countries and partner organizations
  • bioLytical is a Canadian company that develops and manufactures all its tests locally for worldwide distribution
  • bioLytical's INSTI platform of rapid tests is designed to detect a wide range of infectious diseases quickly and accurately
  • bioLytical's quality system is MDSAP: ISO 13485 certified
  • Coalition PLUS is a global NGO, an international union of community–based associations that work to help fight HIV/AIDS and hepatitis

RICHMOND, British Columbia, Nov. 22, 2023 (GLOBE NEWSWIRE) — bioLytical Laboratories Inc. (“bioLytical”), a global leader in rapid in–vitro medical diagnostics and partner Coalition PLUS, a global NGO, announced that together, they have donated and distributed over 8,000 tests across 25 countries to help boost testing access worldwide.

International Testing Week, scheduled for November 22– 28 this year, helps raise awareness of the importance of accessible testing for individual and public health. As one of the vital tools to help connect people to care and to reduce the spread of onward infection, boosting access to testing is critical in the fight to end severe public health challenges such as HIV and hepatitis.

The pandemic has demonstrated the importance of equitable access to rapid and accurate diagnostic testing to curb the spread of infectious diseases. Timely and efficient testing not only saves lives but also assists in minimizing the societal and economic impact of outbreaks.

As part of our commitment and in support of International Testing Week, bioLytical and Coalition PLUS are proud to play a global role in increasing access to testing, reaffirming their dedication to ending some of the world's most severe health challenges.

Robert Mackie, CEO, bioLytical, emphasizes the significance of International Testing Week and states, “International Testing Week serves as a global reminder of the critical role rapid testing plays in safeguarding public health. It is a time to raise awareness about the necessity of early detection, which ultimately contributes to the overall health of communities worldwide. We are proud to support this cause through test donations and to be part of the solution.”

By donating these tests, bioLytical and Coalition PLUS aim to address the disparities in healthcare access and testing capabilities worldwide. Increasing equitable access to testing helps empower healthcare providers with the tools to identify infection and provide care and treatment quickly.

Dr. Bintou Dembele, Vice Chair, Coalition PLUS, says, "Community testing for HIV and STIs helps find undiagnosed people often belonging to hard–to–reach populations. The International Testing Week aims at highlighting outreach interventions that are critical to addressing the remaining gaps to end the HIV epidemic.”

bioLytical Laboratories Inc. is an industry leader in manufacturing rapid in vitro diagnostic tests focusing on infectious diseases with a global mission to ensure every person has access to accurate and reliable tests to learn their status, faster.

Coalition PLUS is an international union of community–based associations in the fight against HIV/AIDS and viral hepatitis created in 2008, operating in 52 countries and alongside some one hundred civil society organizations. They promote innovative methods adapted to the individuals facing the most discrimination in access to healthcare.

In addition to its commitment to International Testing Week, bioLytical continues to innovate and develop cutting–edge diagnostic solutions to meet the ever–evolving needs of the healthcare sector. bioLytical remains dedicated to fostering a healthier, safer, and more connected world through the innovation of rapid diagnostics. By distributing these tests to underserved areas, we hope to facilitate early detection, helping healthcare providers and governments better manage and mitigate the impact of these diseases.

bioLytical Laboratories Inc. is a privately–owned Canadian company focused on researching, developing, and commercializing rapid in–vitro medical diagnostics using its proprietary INSTI technology platform and its lateral flow line, iStatis. bioLytical has won several local and industry awards, including B.C. Exporter of the Year in 2019. We have been named Lifesciences B.C.'s Growth Stage Med Tech Company of the Year and featured on B.C.'s Fastest–Growing Companies for seven years, including the Globe and Mail's Fastest Growing Companies list in 2020. bioLytical moved to a significantly larger, state–of–the–art facility in Richmond, B.C., in 2020 to accommodate the extraordinary growth achieved through our team. Providing accurate results in one minute or less, the INSTI range includes the INSTI HIV–1/HIV–2 Antibody Test, INSTI Multiplex HIV Syphilis Ab Test, INSTI HIV Self Test, INSTI Covid–19 Antibody Test, and the INSTI HCV Antibody Test. bioLytical sells its products in Europe, North America, South America, Africa, and Asia. In 2022, bioLytical launched iStatis, its new lateral flow testing platform, to create additional access to testing worldwide.

By delivering accurate results in real–time, INSTI and iStatis generate meaningful outcomes for medical professionals, patients, and public health organizations worldwide and is a key partner in tackling some of the world's most severe healthcare challenges. Please visit www.istatis.com and www.insti.com, and www.biolytical.com for more information.


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bioLytical Laboratories Inc. Receives Health Canada Authorization for its INSTI® Multiplex HIV-1/2 Syphilis Antibody Test

  • bioLytical has received Health Canada authorization to sell its INSTI Multiplex HIV–1/2 Syphilis Antibody Test across Canada for professional use in point–of–care settings
  • By providing results for two infections with only one sample, the test helps reduce test anxiety for patients by allowing healthcare professionals to test more people in less time
  • The test is portable and can be performed in a multitude of settings with easy–to–understand results
  • As part of the Health Canada review and authorization, the submission included clinical data from the two–year PoSH Study led by researchers at the University of Alberta and St. Michael's Hospital, a site of Unity Health Toronto
  • Test performance in clinical studies demonstrated high accuracy, with industry–leading sensitivity and specificity
  • bioLytical's quality system is MDSAP: ISO 13485 certified

RICHMOND, British Columbia, March 27, 2023 (GLOBE NEWSWIRE) — bioLytical Laboratories Inc. (“bioLytical”), a global leader in rapid in–vitro medical diagnostics, announced today that it has received Health Canada authorization for its INSTI Multiplex HIV–1/2 Syphilis Antibody Test, allowing its immediate entry into the Canadian market. Furthermore, bioLytical is working on a self–test version to ensure Canadians of all demographics can access regular and early testing for both infections, where and when it works best for them.

“I am proud to lead a team of hardworking and innovative individuals who consistently push the boundaries of what is possible,” says Rob Mackie, CEO of bioLytical. “Our continued dedication to excellence allowed us to achieve this remarkable milestone that will help Canadians across all demographics access early testing in various settings.”

As a well–known leader in global HIV testing with its innovative INSTI HIV–1/2 Antibody Test, authorized by Health Canada for both professional and self–testing use, bioLytical has leveraged its proprietary INSTI technology to develop the INSTI Multiplex HIV–1/2 Syphilis Antibody Test, first approved and in use across Europe and Africa since 2016.

The test is designed to detect both HIV–1/2 and syphilis antibodies with one sample using a simple fingerprick method to deliver accurate results in one minute or less. Mobile and simple to use, INSTI allows healthcare professionals to test in various environments, providing flexible options for persons that face barriers to accessing healthcare.

As part of Health Canada's review and subsequent authorization, the two–year Point of Care Tests for Syphilis and HIV (PoSH) Study, completed between August 2020 and February 2022, was included in the submission process. The Study, led by researchers at the University of Alberta and St. Michael's hospital, a site of Unity Health Toronto, showcased the importance of regular and frequent testing to help connect patients to care. Due to the real–time results that the innovative INSTI platform provides, those who tested positive for HIV were either linked or relinked to care, and of those that tested positive for active syphilis, the majority (87.4%) were treated immediately following point–of–care test results, and the remaining participants were treated within a median of four days.

Syphilis is a serious health issue that can lead to long–term health consequences if left untreated. Canada is currently experiencing unprecedented syphilis infection rates, with a 166% nationwide increase from 2017–2021. Rates have increased across all demographics, with new infections increasing by 20% between 2020 and 2021 despite decreased access to STBBI services during the pandemic. Furthermore, there is a growing concern about increasing congenital syphilis, with a 1271% increase in the same period.

With an estimated 62,790 persons living with HIV (PLWH) in Canada and with an estimated 1,520 new HIV infections annually, co–infection with syphilis and HIV is a growing concern. While both infections can affect anyone, having a STI such as syphilis increases the chance of acquiring HIV and in PLWH, increases the chances of passing on HIV. Additionally, syphilis sores or ulcers can allow HIV and other STIs to enter the body.

Rapid testing is instrumental in ending HIV and syphilis as public health threats. Regular and early access to testing allows medical professionals to offer early interventions by quickly connecting patients to care and support, reducing onward transmission, and increasing awareness of prevention methods.

If syphilis is diagnosed within a year of infection, it can usually be treated with a single injection of medication. HIV treatment has also progressed significantly since the virus was identified over 40 years ago, allowing persons living with HIV to lead long and healthy lives on treatment. Creating a test that can identify both infections with a single sample helps ensure that Canadians can connect to care quickly and equitably. The INSTI Multiplex HIV–1/2 Syphilis Antibody Test is an innovative and efficient approach to increasing access to early and regular testing for sexually transmitted and blood–borne infections (STBBIs) in Canada.

“With the rise of syphilis in Canada, including the concerning increase in congenital syphilis, there is an urgent need for a fast and reliable rapid diagnostic test,” said Mackie. “With the development of a highly accurate and innovative one–minute test, INSTI allows Canadians to learn their status to two infections with only one drop of blood, helping more Canadians access testing, learn their status, and connect to care.”

bioLytical will manufacture the INSTI Multiplex HIV–1/2 Syphilis Antibody Test in its MDSAP: ISO 13485–certified facility in British Columbia to sell and distribute across Canada. As a global leader in ultra–rapid infectious disease diagnostics, bioLytical is working to ensure our test kits are available to Canadians so they can know their status.

bioLytical Laboratories Inc. is a privately–owned Canadian company focused on researching, developing, and commercializing rapid in–vitro medical diagnostics using its proprietary INSTI technology platform and its lateral flow line, iStatis. bioLytical has won several local and industry awards, including B.C. Exporter of the Year in 2019. We have been named Lifesciences B.C.'s Growth Stage Med Tech Company of the Year and featured on B.C.'s Fastest–Growing Companies for six years, including the Globe and Mail's Fastest Growing Companies list in 2020. bioLytical moved to a significantly larger, state–of–the–art facility in Richmond, B.C., in 2020 to accommodate the extraordinary growth achieved through our team. Providing accurate results in one minute or less, the INSTI range includes the INSTI HIV–1/HIV–2 Antibody Test, INSTI Multiplex HIV Syphilis Ab Test, INSTI HIV Self Test, INSTI Covid–19 Antibody Test, and the INSTI HCV Antibody Test. bioLytical sells its products in Europe, North America, South America, Africa, and Asia. In 2022, bioLytical launched iStatis, its new lateral flow testing platform, to create additional access to testing worldwide.

By delivering accurate results in real–time, INSTI and iStatis generate meaningful outcomes for medical professionals, patients, and public health organizations worldwide and is a key partner in tackling some of the world's most severe healthcare challenges. Please visit www.istatis.com and www.insti.com, and www.biolytical.com for more information.

References

CATIE: https://www.catie.ca/syphilis–0
PHAC: https://www.canada.ca/en/public–health/services/reports–publications/canada–communicable–disease–report–ccdr/monthly–issue/2022–48/issue–11–12–november–december–2022/infectious–congenital–syphilis–canada–2021.html
PHAC: https://www.canada.ca/en/public–health/services/publications/diseases–conditions/estimates–hiv–incidence–prevalence–canada–meeting–90–90–90–targets–2020.html

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4adaf035–89ca–428d–a01d–9bf5c3f05e4b


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