IQuum Awarded NIAID Phase II Grant for Development of Point-of-Care HIV Viral Load Test

Marlborough, MA, December 7, 2009 – IQuum, Inc. announced today that it has been awarded a Phase II grant from the National Institute of Allergy and Infectious Disease (NIAID) for the development of a lab-in-a-tube based point-of-care (POC) test for the detection and quantitation of Human Immunodeficiency Virus-1 (HIV-1). This award follows the successful completion of Phase I work, and IQuum’s demonstration of the feasibility of detecting and quantitating HIV-1 in 60 minutes on the Liat™ Analyzer. In Phase II, IQuum proposes to complete the development and analytical characterization of the Liat™ HIV-1 Quant Assay.

“HIV remains a global healthcare concern, particularly in resource-limited settings,” said Dr. Shuqi Chen, CEO of IQuum. “We are pleased to receive this NIAID award and believe that the combination of NIAID support and IQuum’s Liat technology will lead to the first point-of-care device for HIV-1 viral load monitoring.”

Early HIV detection and viral load monitoring provide critical indicators for patient progression and clinical outcome. Although HIV testing is widely available in the US, late diagnosis is still common, with 37% of patients first discovering they have HIV less than 1 year before an AIDS diagnosis. Additionally, 31% of those who test positive at CDC funded HIV testing sites do not return for results. A highly sensitivity point-of-care test that enables testing to be performed in non-traditional settings and provides results immediately can help stem the tide of new infections.

For HIV therapeutic monitoring, current US clinical guidelines call for plasma viral load measurements before initiation of antiretroviral therapy (ART) and repeat viral load testing every 3-4 months to monitor treatment efficacy. While access to ART in resource limited settings have improved in recent years, the availability of tests to monitor response to ART still lags behind. Because of the technical complexity and high cost of current quantitative tests, HIV viral load testing is largely unavailable in resource limited settings. Research has shown that using immunological and clinical definitions alone may misclassify up to 56% of patients, and identify patients late in the failure process, resulting in poorer clinical outcomes and an increased risk of AIDS defining events or death.

The Liat HIV-1 Quant Assay is intended to address the need for improved diagnostic and monitoring tools. The test will overcome the long turnaround time, technical complexity, and stringent process and personnel requirements of current tests. By enabling testing to be done on-site and in less than 1 hour, the Liat HIV-1 Quant Assay is expected to allow physicians and patients to receive results in the same office visit and make treatment decisions without delay. Such a near-patient on-demand test will raise the standard-of-care for the patient, increase convenience for the clinician, and prevent the spread of disease for public health.

About the Liat™ Analyzer

The Liat Analyzer is a fully automated, portable and standalone molecular diagnostics system that promises to deliver the advancements in biotechnology to daily life. The system refines nucleic acid testing to three simple steps: collecting a raw biological sample such as whole blood into a Liat Tube, scanning the tube's barcode, and inserting the tube into the Liat Analyzer. The analyzer automatically executes all the required assay steps, including reagent preparation, target enrichment, inhibitor removal, nucleic acid extraction, amplification and real-time detection, and reports test results on the built-in touch screen within 1 hour. No further operator intervention or data interpretation is required. The system’s simplicity, along with its closed tube design and robust error prevention features, makes it ideally suited for near-patient molecular diagnostics and field operated applied tests.

IQuum is the leader in developing lab-in-a-tube technology, a novel biological sample testing platform which provides revolutionary benefits to a broad cross section of the bioassay market. The Company's proprietary technology enables the non-specialized personnel to perform more sophisticated biological sample testing in any setting with greater speed. Founded in 1998, the Company is commercializing its lab-in-a-tube technology and products for the clinical diagnostics, bio-defense, and industrial testing markets. For more information, please visit www.IQuum.com.

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