MedMira Submits Syphilis/HIV Combination Test for WHO Approval Upon Invitation to Prequalification Program
HALIFAX, March 11, 2013 /CNW/ - MedMira Inc., (MedMira) (TSXV: MIR), a developer of rapid diagnostic technology and solutions, announced today that it has submitted an application for its Multiplo Syphilis/HIV rapid test (also known as Multiplo TP/HIV) to the World Health Organization (WHO) Prequalification of Diagnostics program. The Company received a letter of invitation from the WHO to submit Multiplo Syphilis/HIV for prequalification. This invitation comes as MedMira's Reveal HIV rapid test is in the final stages of the WHO prequalification program.
As a leader on global health matters, one of the WHO's focus areas is the elimination of mother-to-child transmissions of both Syphilis and HIV. Globally, Syphilis caused 300,000 stillbirths and neonatal deaths in 2008, and 390,000 children were newly infected with HIV in 2010.
"Independent studies led by our team in Canada and India and Canadian Institutes of Health Research funded meta-analyses have proved that point-of-care tests for HIV, Syphilis, and related co-infections, offer expedited screening solutions for pregnant women and marginalized populations for both resource rich and resource poor settings. Their high accuracies facilitate expedited clinical decision making, allow for same day triage to staging and treatment, and prevent loss to follow up of patients. Point-of-care technologies are the now and the future of diagnostics," said Dr. Nitika Pant Pai, MD., PHD an Assistant Professor of Medicine at McGill University, and a medical scientist at the Research Institute of the McGill University Health Centre. "The technology is a game changer."
The WHO recommends that all pregnant women be screened for Syphilis, HIV and other diseases to prevent passing these infections on to their babies. This recommendation is not always carried through to practice due to lack of resources, under developed healthcare systems, and general lack of public awareness. However, there is currently a widespread scale-up of HIV screening for pregnant women which presents a "golden opportunity" to screen for Syphilis at the same time, capitalizing on existing infrastructure, creating greater awareness, and preventing babies born with Syphilis and HIV.
"Our Multiplo Syphilis/HIV combination test will positively impact screening programs for pregnant women, as well as others. We were pleased to receive the invitation letter and welcome the opportunity to work with the WHO, a leader in public health, to bring these testing solutions to global healthcare markets," said Neeraj Vats, Director of Technology and Business Affairs, MedMira Inc. "Our Multiplo tests, which provide simultaneous results for multiple diseases, deliver the efficiency, performance, and results needed to support the prevention of mother-to-child transmission of diseases like Syphilis and HIV. As both developing and developed regions of world deal with limited healthcare dollars and increasing co-infections, screening for HIV alone is no longer enough."
The Company has submitted the application form and is preparing the in-depth Multiplo Syphilis/HIV product dossier. The WHO Prequalification of Diagnostics program undertakes a comprehensive assessment through a standardized procedure. The prequalification procedure includes three main components:
- Review of an application form and product dossier
- Laboratory evaluation of the product; and
Inspection of the manufacturing site(s).
Vats continued, "We are very familiar with the WHO process for evaluating diagnostics, just having recently completed the final steps for prequalification of our Reveal HIV product. The invitation to submit an additional test for approval coming so quickly on the heels of our first submission clearly demonstrates the capabilities, performance, and reputation of our distinctive technology platform within the industry."
MedMira is a leading developer and manufacturer of flow-through rapid diagnostics. The company's tests provide hospitals, labs, clinics and individuals with reliable, rapid diagnosis for diseases such as HIV and hepatitis C in just three minutes. The company's tests are sold under the Reveal®, Multiplo™ and Miriad brands in global markets. MedMira's rapid flow-through HIV test is the only one in the world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira's corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit MedMira's website at www.medmira.com.
This news release contains forward-looking statements, which involve risk and uncertainties and reflect the Company's current expectation regarding future events including statements regarding possible future growth and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.
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SOURCE: MEDMIRA INC.For further information:
Andrea Young, Corporate Communications