IQuum to Enter Clinical Trials of Liat™ Analyzer for Leishmaniasis Diagnostics under Phase II US Army Contract

Allston, MA, July 19, 2005 -- IQuum, Inc. today announced that it has successfully competed the first phase of the Department of Defense (DOD) contract entitled “Nucleic Acid Analyzer for Battalion Aid Station Triage” and has been awarded a Phase II contract to validate the Liat™ Analyzer and Liat™ Leishmaniasis Assay in clinical studies. IQuum further announced today that it intends to apply for FDA clearance for this test through a 510k submission. Supported by the US Army Medical Research and Materiel Command (USAMRMC), this two phase project is aimed at developing a rapid and automated nucleic acid test for detecting cutaneous leishmaniasis based on IQuum’s proprietary lab-in-a-tube technology.

“We are pleased that the DOD is satisfied with our Phase I results, and look forward to bringing the Liat Analyzer and the Liat Leishmaniasis Assay through the FDA clearance process, and to delivering the next generation of rapid and easy-to-use cutaneous leishmaniasis tests to our troops overseas.” said Dr. Shuqi Chen, CEO of IQuum.

Cutaneous leishmaniasis is a sand fly-borne parasitic infection that is prevalent in parts of the Middle East, Africa, and Asia. In last few years, nearly 1,000 US military personnel have been affected by leishmaniasis in Iraq, where the disease has been nicknamed “Baghdad Boils.” In response to this disease incidence, the US Army is seeking next generation diagnostic tools for detecting leishmaniasis. Current leishmaniasis diagnostics rely heavily on cell culture, which is laborious and takes 2 to 3 weeks to complete. Although PCR based tests have been developed, such tests involve technical manual processes and require highly controlled laboratory facilities, thus preventing their use in forward military medical field facilities. Currently, testing for leishmaniasis is conducted primarily at Walter Reed Army Institute of Research in Silver Spring, Maryland, where clinical samples are shipped from overseas.

Leveraging the lab-in-a-tube platform, the Liat Leishmaniasis Assay is expected to fulfill the need for improved diagnostics by providing fully automated raw-sample-to-result testing in approximately one hour. The system conducts all nucleic acid testing steps including target enrichment, inhibitor removal, DNA extraction and real-time PCR detection. The ease of use of the Liat Analyzer, its portability, and its closed tube design facilitates deployment to forward clinics in support of military personnel overseas.

Colonel Alan J. McGill M.D., Science Director of the Walter Reed Army Institute of Research, expressed his interest in the IQuum project, "We look forward to working with IQuum and wish them great success in this next phase of their project.”

In Phase I of this project, IQuum successful developed the fully automated leishmaniasis assays on the Liat Analyzer. In a pre-clinical study performed at IQuum, the assay was demonstrated to be robust, sensitive and specific. In this Phase II contract, IQuum will carry out the clinical study at three clinical centers to validate the system. Upon successful completion of this project, IQuum expects that the Liat Analyzer and the Liat Leishmaniasis Assay will become available for procurement, specifically for military units at home and overseas.

“We are very excited about this project because leishmaniasis diagnostics represents the first of many clinical Liat assays for which FDA 510(k) clearance will be sought,” Dr. Chen added. “The significance of this project extends far beyond leishmaniasis diagnostics; this program brings us one step closer to applying the Liat Analyzer system broadly over clinical diagnostics markets, including infectious diseases, cancer markers and predisposition testing.”

About IQuum, Inc.

IQuum is a leader in developing lab-in-a-tube technology, a novel biological sample testing platform intended to provide revolutionary benefits to a broad cross section of the bioassay market. The Company's proprietary technology will enable the less experienced professional to perform more sophisticated biological sample testing in a less expensive setting with greater speed. The lab-in-a-tube platform is the foundation of next generation tools for clinical diagnostics, biodefense, and industrial testing. Founded in 1998, IQuum is located in the Boston metropolitan area in Massachusetts. For more information, please visit www.IQuum.com.

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