GlobeNewswire

INSTI HIV Self Test Earns WHO Prequalification Status for Home Testing

Del

The newly WHO Prequalified INSTI HIV Self Test makes a mark as it expands into new markets

VANCOUVER, British Columbia, Nov. 28, 2018 (GLOBE NEWSWIRE) -- bioLytical Laboratories, a world leader in rapid infectious disease tests, is pleased to announce that its INSTI® HIV Self Test has been Prequalified by the World Health Organization (WHO).  INSTI, the world’s fastest home test providing results in 1-minute, becomes the first and only blood-based HIV self-test to be WHO Prequalified.

The INSTI HIV Self Test allows individuals to discreetly screen for HIV in the comfort of their own home using easy-to-understand, field-tested pictorial instructions.  The product is based on the INSTI HIV-1 / HIV-2 Antibody Test, which is the only rapid HIV test to be approved by the US FDA, Health Canada, WHO and European Union (CE Mark).  Because of this, INSTI is trusted by health care professionals across the globe with over 15 million rapid tests used in more than 60 countries.  The ease-of-use, reliability and convenience of a one-minute blood test was adapted from the point-of-care product to one carefully curated for home use.

WHO Prequalification signifies that the product meets the highest global standards of quality, safety and performance. The strict assessment includes a review of the product’s technical performance, inspection of manufacturing site, and a laboratory evaluation of the product.  Data supporting the INSTI HIV Self Test Prequalification demonstrates that the test has up to 100% sensitivity and 100% specificity when compared to a fourth generation HIV antigen/antibody ELISA test.  Rigorous field studies showed more than 95% of participants found the INSTI HIV Self Test easy to use, they would use it again and recommend to partners and family members.  A large focus is investigating a product’s suitability for use in resource-limited settings.  Only after the product has passed each stage and meets the prequalification requirements can it become eligible for inclusion by United Nations (UN) and other procurement agencies, such as Unitaid, PEPFAR, and/or the Global Fund.

“Unitaid is delighted that WHO has, for the first time, prequalified a safe and reliable blood-based self-test for HIV.  This now gives countries a choice of quality-assured self-tests to offer to individuals so they can find out their HIV status and is a critical step in fulfilling Unitaid’s strategic investment objective of building a healthy global market for these vital devices,” said Unitaid’s Executive Director, Lelio Marmora.

Based on its performance and usability, the INSTI HIV Self Test was selected for use in the UNITAID/PSI HIV Self-Testing Africa (STAR) Initiative, which is the world’s largest ongoing demonstration of HIV self-testing to date.  The multi-year STAR project is an initiative to catalyze the market for HIV self-testing by generating information on how to distribute HIV home tests effectively and ethically, as well as scale up successful distribution models.

“We will continue to support countries as they develop and launch their self-testing policies, guidelines and programs, with expected launches into South Africa, Zimbabwe, Zambia, Malawi, Rwanda and Nigeria in early 2019 and then globally as in-country policies come into effect,” said Ryan Bennett, bioLytical’s Vice President, Global Business Solutions. 

“Our portfolio of point-of-care and self-tests have become well-known market leaders across Europe and North America.  We are proud to have this certification as we continue to bring this highly-anticipated and much-needed one-minute test to Africa, as well as North America, Asia and Latin America.  Over the past year, countries and consumers have been actively calling for a quick, easy-to-use, blood-based test and with the achievement of WHO Prequalified status, we are now able to fill this demand.”

The INSTI HIV Self Test is already available in retail locations and online in France, UK, Germany, Spain, Portugal, Ireland, Netherlands, Belgium, Austria, Estonia, Finland, Italy, Switzerland and Kenya.  Pilot programs are taking place in Armenia, Ukraine and Taiwan, with groundbreaking self-test studies using INSTI taking place globally. Approval of the INSTI home test further supports early detection of HIV infection and facilitates more effective interventions through 1-minute results and IgM detection capabilities.

About bioLytical Laboratories Inc.

bioLytical Laboratories Inc. is a privately-owned Canadian company engaged in the research, development and commercialization of rapid, point of care in vitro medical diagnostics using its proprietary INSTI technology platform.  With a world-wide footprint of regulatory approvals including US FDA approval, Health Canada approval and CE mark, bioLytical markets and sells its INSTI HIV test globally and INSTI HIV/Syphilis Multiplex test in Europe.  The INSTI product line provides highly accurate test results in 60 seconds or less, far faster than the 15-20 minutes required for competitors’ tests based on lateral flow technology.  bioLytical has an active R&D program with a pipeline that includes tests for diseases such as Zika, Hepatitis C, Hepatitis B and Ebola, among others.  The company also provides contract services to adapt the INSTI platform to meet custom functional and technical diagnostic testing requirements.  For more information, please visit www.biolytical.com.

Eva Siu
Marketing Manager
+1 604 204 6784
info@biolytical.com

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/cea4e105-55a2-40d1-be7e-8538e236f003

Om GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Følg saker fra GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra GlobeNewswire

Test Release - 25-05-2019 - 21108925.5.2019 15:39:00 CESTPressemelding

Test Sub Headline - 2067088 Chicago, May 25, 2019 (GLOBE NEWSWIRE) -- American HealthCare Lending, the leading non-recourse patient financing platform serving health systems, physician groups, surgical centers, and other healthcare providers throughout the country, today announced that it will showcase its patient financing platform at the Healthcare Financial Management Association's ANI 2014 Conference in Las Vegas June 22-25. Hosted by the nation's leading membership organization for healthcare financial management executives and leaders, HFMA's 2014 National Institute is a place for top executives and key decision makers to explore solutions to the most pressing issues facing the industry. American HealthCare Lending's patient financing solution addresses one of these key issues, the dramatic rise in out-of-pocket patient responsibility, by delivering financing options designed to fulfill the company's mission to Make Healthcare Affordable™. Attachment sample

Biome Grow Inc. to Announce First Quarter Fiscal 2019 Financial Results.24.5.2019 19:08:00 CESTPressemelding

TORONTO, May 24, 2019 (GLOBE NEWSWIRE) -- Biome Grow Inc. (“Biome” or the “Company”) (CSE:BIO, OTCQB: BIOIF, 6OTA:GR) will release its financial results for the first quarter ended March 31, 2019 before market open on May 29, 2019. Following the release of its first quarter 2019 financial results, Biome will host a conference call and audio webcast with Khurram Malik, CEO at 8:30am Eastern Time May 29, 2019. Webcast information A live audio webcast will be available at https://event.on24.com/wcc/r/2015980/CEAD1B37BDD7710D021A38D2B79B5C45 Calling Information Toll Free Dial-In Number: 1 (866) 211 3199 International Dial-In Number (647) 689 6601 Conference ID 8693906 About Biome Biome wholly owns five subsidiaries, including: The Back Home Medical Cannabis Corporation, a company incorporated under the laws of the Province of Newfoundland and Labrador and in the late stages of applying for a license under the Cannabis Act; Great Lakes Cannabis, a company incorporated under the laws of the

Jason Lamb of Gates Foundation Named New Chair of CGAP’s Executive Committee24.5.2019 17:04:00 CESTPressemelding

CGAP CEO calls for renewed focus on retail credit to support growth and jobs for the poor Beirut, Lebanon, May 24, 2019 (GLOBE NEWSWIRE) -- Jason Lamb from the Bill & Melinda Gates Foundation, was elected chair of the Executive Committee for The Consultative Group to Assist the Poor (CGAP) at its annual meeting on Wednesday. Lamb will succeed Carolina Trivelli, senior researcher at the Instituto de Estudios Peruanos and Peru’s former Minister of Development and Social Inclusion. Under Trivelli’s leadership CGAP adopted its new five-year strategy and theory of change that places empowering the poor through financial services to capture opportunities and build resilience at the heart of CGAP’s work. At the Gates Foundation, Lamb is Deputy Director, Financial Services for the Poor (FSP) and manages focus country implementation in Bangladesh, Pakistan, Indonesia, Nigeria, Tanzania, Kenya and Uganda. He has served on CGAP’s Executive Committee, which functions like a board of directors prov

Gainsight Unveils the Customer Cloud, the Future of Customer Success Technology23.5.2019 19:30:00 CESTPressemelding

New Products Announced at Pulse 2019 to Drive Customer Success Across the Enterprise SAN FRANCISCO, May 23, 2019 (GLOBE NEWSWIRE) -- Today, Gainsight® launched the Customer Cloud —a first-of-its-kind solution for subscription businesses looking to adopt a customer-centric philosophy that enables them to retain customers while also driving company growth post-sale. According to the 2018 Subscription Economy Index report, subscription companies are growing five times faster than S&P and retail sales. The Gainsight Customer Cloud caters to these businesses by combining the company’s Customer Success and Product Experience products with three new product innovations to offer a powerful set of solutions for businesses to optimize their subscription strategies through technology. “With the maturity of cloud technology and the subscription economy, customer expectations have drastically changed. Companies are struggling to leverage existing tools to satisfy the increasing demands of their cus

Lowered Return Expectations Among Several Trends Pointing to a Shift in Private Markets Due Diligence says New eVestment Survey23.5.2019 15:30:00 CESTPressemelding

ATLANTA, May 23, 2019 (GLOBE NEWSWIRE) -- Private markets funds have continued to rake in new commitments from institutional investors eager to diversify their portfolios and capture the returns private markets investments can offer. However, investors are now tempering their private markets return expectations. Coupled with other industry trends, this will have implications for private markets fundraising and due diligence according to a new eVestment report, produced in association with parent company Nasdaq. The 2019 eVestment Private Markets Due Diligence Survey of institutional investors, consultants and private markets fund managers finds that 52% of investors expect returns in the space to decline in the future (page 16). Only 12% of investors expected private equity returns to increase, with the balance – 36% – expecting returns to stay about the same. Forty-seven percent of investors surveyed expect to see lower returns in venture capital vs. just 16% of investors who expect r

Collibra Announces 2019 Excellence Awards Winners23.5.2019 15:00:00 CESTPressemelding

American Express, Deloitte, and Lloyds Banking Group recognized as leaders in harnessing data to drive digital transformation NEW YORK, May 23, 2019 (GLOBE NEWSWIRE) -- Collibra, the leader in enterprise data governance and catalog software, today announced the winners of the 2019 Collibra Excellence Awards. Presented at the annual Data Citizens conference in New York, the awards honor teams and individuals driving innovative data strategy by collaborating with Collibra. “In today’s market, organizations that are able to maximize data have the power to transform entire industries,” said Felix Van de Maele, co-founder and CEO of Collibra. “We’re proud to honor the recipients of the Collibra Excellence Awards, a cutting-edge group at the forefront of data-driven innovation.” The 2019 Collibra Excellence Award Winners: American Express — Distinguished Data Program of the Year American Express was recognized for its data governance transformation, which began as a compliance initiative and