Halifax, U.S.A. — Under a US Army contract valued at USD$4.2 million, MedMira will develop and commercialize this multiple rapid test which detects HIV, Hepatitis B and C simultaneously in 3 minutes from a single drop of blood.

MedMira Inc., a developer of rapid diagnostic technology and solutions, announced today that it has been awarded a U.S. Army Medical Research Acquisition Activity (USAMRAA) contract to develop and commercialize a rapid test capable of simultaneous detection of HIV and Hepatitis B and C.

The contract, awarded through a competitive bid process, involves a two-year base period and a 10-month option with a value of USD$4,266,144, if all options are exercised. MedMira presented its technology and multiple rapid tests, which met the U.S. Army’s advanced technology readiness level requirements. The Multiplo Rapid HBV/HIV/HCV Antibody Test resulting from this contract award will be deployed on the frontlines of military healthcare for use in emergency screening for transfusion transmitted diseases where no FDA approved donor screening tests are available. The military could also put the test to use during pre and post deployment screenings and civilian disaster relief efforts.

“We are thrilled to receive this new contract from USAMRAA for the development and commercialization of our Multiplo test. This contract award demonstrates the excellent fit between MedMira’s technology and products and military requirements. We have built a lasting relationship with the U.S. Army, delivering advanced diagnostic solutions that reduce the need for militaries to undertake ground-up development work,” said Hermes Chan, CEO, MedMira Inc. “MedMira’s technology and products are elegantly simple, portable, fast, and high quality. All of these attributes are mission critical in deploying diagnostic healthcare solutions on the frontlines of military healthcare.”

Chan continued, “Our team recently attended a conference focused on military pre-hospital trauma management where we heard first hand of the need for a multiple rapid HBV/HIV/HCV test from many of the leading experts, military personnel, and medical professionals in this field.”

Under contract number W81XWH-12-C-0151 the U.S. Army will fund all development costs and associated fees in obtaining a U.S. Food and Drug Administration (FDA) premarket approval (PMA) for this multiple rapid test. The scope of work under this contract will see MedMira advance and fully commercialize a multiple rapid test that will simultaneously detect three of the most serious infectious diseases, namely HIV-1/2, Hepatitis B, and C antibodies within three minutes using just a small drop of blood. Once approved, the product will be supplied by MedMira directly to the U.S. Army and to other customers throughout the world, both military and civilian, via the Company’s distribution network.

“A multiplexed test for transfusion transmitted diseases provides an enabling technology that will be used to mitigate risk in austere environments where emergency blood collections are necessary to save lives of severely wounded war fighters,” said Colonel Richard Gonzales, Product Manager, U.S. Army Medical Materiel Development Activity.

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Experts at Montefiore Medical Center urge the general public to be tested for the Hepatitis C virus, especially baby boomers, adults born between 1946-1964, who could be most at risk for this disease. Baby boomers are more likely to have been exposed to dangerous risk factors decades ago, such as sharing a drug needle, being tattooed or pierced with unsterilized tools or receiving a tainted blood transfusion.

The disease often has no symptoms, and if untreated, can lead to chronic infection that can scar the liver, cause liver failure or cancer and potentially lead to liver transplantation.

Hepatitis C virus (HCV) is the most common chronic blood borne infection in the United States, with 35,000 to 185,000 new cases diagnosed per year. Worldwide, 180 million people are chronically infected with Hepatitis C, with an estimated 3-4 million new cases reported each year. The disease particularly affects minorities, Hispanics, Asian-Americans and African-Americans.

“This disease has grown to epidemic proportions, with 350,000 people around the world dying from Hepatitis C-related liver disease,” said Milan Kinkhabwala, MD, Chief, Division of Transplantation at the Montefiore Einstein Center for Transplantation. “But it is called the ‘silent killer’ because many people don’t even know they have it.

This condition can be asymptomatic for decades and then present itself when it has already severely damaged the liver.” Individuals at risk can get a simple blood test to detect the virus before chronic infection leads to permanent liver damage. The Montefiore Medical Center Comprehensive Liver Disease Program offers simple and effective screenings.

It is recommended that individuals talk to their primary care physician or contact 888-RX-LIVER (888-795-4837) for more information or to set up an appointment for a screening. ”This is a revolutionary time in the treatment of the disease and there is more hope than ever before,” said Dr. Kinkhabwala. “The blood test is essential to detecting Hepatitis C, because now there are ways to treat the condition, and even reverse damage to the liver.”

Two new anti-viral oral medications, boceprevir and teleprevir, received FDA approval in May 2011. Both drugs work by blocking an enzyme that helps the virus reproduce. The drugs are intended to improve on standard treatments using the injected drug pegylated interferon alpha and the pill rivavrin.

“So far, the new drugs have shown promise in clearing the virus from the body and almost doubling the cure rate of the disease,” said Allan Wolkoff, MD, Professor of Medicine and of Anatomy and Structural Biology at Albert Einstein College of Medicine of Yeshiva University and Chief of the Division of Gastroenterology and Liver Diseases at Montefiore and Einstein.

“Another key benefit is that they cut treatment time in half, thus reducing the time the patient has to endure the severe side effects, which include anemia, depression and flu-like symptoms like fatigue, fever and headache.”

When symptoms do occur after the disease has progressed, they’re generally mild and flu-like and may include fatigue, fever, nausea or poor appetite, muscle and joint pain, bruising, abdominal pain, jaundice and itching. At that point, chronic infection can lead to scarring of the liver (fibrosis) and then advanced scarring (cirrhosis).

Scarring of the liver makes it difficult for the liver to function properly and can be devastating to the rest of the body, often causing liver failure or liver cancer. If the liver disease progresses too far and the medications are not effective, then transplantation is the last resort. However, more than 16,000 people in the United States are currently waiting for a liver donor, and in New York State, there are 1,700 patients on the waiting list.

Factors that have been reported to accelerate the rate of HCV disease progression include age, gender (males have more rapid disease progression than females), alcohol consumption, HIV coinfection (approximately 35% of patients) and fatty liver (the presence of fat in liver cells caused by obesity).

Unlike Hepatitis B, there is no vaccine to prevent this disease. While the symptoms are similar, distinct differences exist between the two viruses. Hepatitis B is primarily transmitted through sexual intercourse and is less severe. Dr. Kinkhabwala will be available for a live twitter chat to answer questions about Hepatitis C and liver disease on December 8, 2011 at noon. Follow @MontefioreNews to discuss #MonteHepC.

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