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Wave 80 awarded $7.5 million NIH contract for HIV rapid virus testing

Next-generation point-of-care molecular diagnostic system meets challenges of detecting acute infections, monitoring recipients of candidate vaccines, and diagnosing infants born to HIV-infected mothers.

San Francisco, California, October 28 2009. Wave 80 Biosciences, Inc. today announced that it has been awarded a USD 7.5 million contract (HHSN272200900029C) by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, Department of Health and Human Services, for rapid HIV/AIDS nucleic acid testing systems for use in low resource settings.

Nucleic acid tests (NATs) are sophisticated blood tests for directly measuring the amount of virus circulating in the bloodstream. In HIV vaccine clinical trials, NATs performed on blood samples from trial participants are critical for differentiating HIV infection from the physiological response to the candidate vaccine. NATs are also the only reliable method for assessing how well an HIV-infected individual undergoing therapy is suppressing viral replication; for determining whether an infant born to an HIV-infected mother has contracted the disease; and for detecting HIV at the earliest stages of infection.

Wave 80’s EO-NAT HIVTM system, part of the company’s EOSCAPETM molecular diagnostic product family, is the first NAT system designed from the outset to operate across the full spectrum of environments where clinical laboratory testing is needed, ranging from sophisticated high-throughput laboratories to small clinics in remote areas. The new NIH contract provides for system optimization and enhancement to measure HIV virus in the bloodstream down to extremely low levels—a few hundred copies of virus or less in each sample—in a period of less than two hours.

“Physicians, patients, and clinical researchers alike have been clamoring for the capability to detect miniscule quantities of virus with a fast time-to-result and compact, robust instrumentation,” said Daniel Laser, Ph.D., Wave 80’s CEO. “The EO-NAT HIV not only meets these specifications, it does so with a one patient-one test operational model that’s both practical and economical.”

The amount of the virus in a patient’s bloodstream is known as viral load. Along with CD4+ T cell count, viral load is a key parameter considered by physicians to assess disease progression and to evaluate how well the patient is responding to therapy with antiretroviral drugs. Measuring the presence of the virus itself also tells doctors different kinds of information than can be learned from traditional HIV diagnostics, which indicate whether the patient has produced antibodies to the virus.

While infants born to HIV-infected mothers can contract the disease in utero or during passage through the birth canal, the vast majority escape infection. Yet, whether infected or not, most of these children will carry antibodies to HIV from their mother until they are well over a year old—meaning that they will test positive on a traditional HIV diagnostic.

As a result, the best way to avoid administering antiretroviral drugs to infants who don’t need them is to run a series of NATs during the first months of life. “Early infant diagnosis, or EID, is widely considered to be one of the most pressing issues in HIV patient care,” said Dr. Sharon Safrin, Wave 80’s Clinical Affairs Specialist. “The EO-NAT HIV’s unique capabilities for EID promise to dramatically improve outcomes for newborns.”

HIV vaccines undergo exhaustive clinical trials with huge numbers of volunteers—some sixteen thousand men and women participated in the combination Alvac-Aidsvax trial completed last month. Trial participants who develop immunity to the disease are likely to produce the very same antibodies as HIV-infected individuals, necessitating the use of NATs to definitively differentiate true infection from this vaccine-induced seroconversion.

The EO-NAT HIV uses next-generation molecular signal amplification technology to achieve accurate results even with samples which have not been maintained in pristine condition. Recent studies demonstrating the effectiveness of concerted antiretroviral therapies during pregnancy at preventing mother-to-child transmission have taken place in remote regions of Africa and east and southeast Asia. The Alvac-Aidsvax trial took place in coastal Thailand.

The duration of the new NIH contract is five years. Wave 80 has previously received funding for molecular diagnostics research and development under the Small Business Innovative Research program from both NIH and the U.S. Department of Defense.

Besides Wave 80, project participants include the Boston University College of Engineering and Siemens Healthcare Diagnostics.

About Wave 80

Wave 80 Biosciences is a research-driven medical technologies company developing innovative molecular assay methods, novel techniques for leukocyte analysis and fractionation, and next-generation clinical laboratory testing systems. The centerpiece of Wave 80’s product pipeline is the EOSCAPE family of high-performance, compact-form-factor systems for measurement of high-clinical-value biomarkers in peripheral blood. Wave 80 is headquartered in San Francisco, California.