IQuum Launches First Clinical Trial for One Hour Molecular Diagnostics on Liat™ Analyzer

Orlando, Florida, at the XIX International Congress of Clinical Chemistry and 2005 Annual Meeting of the American Association for Clinical Chemistry (AACC), July 27, 2005 -- IQuum, Inc. today announces that it has launched the first clinical trial for the Liat™ Analyzer for rapid molecular diagnostics. Supported by the US Army Medical Research and Materiel Command (USAMRMC), this clinical trial will validate the Liat Analyzer for the diagnosis of cutaneous leishmaniasis and provide the US military with the next generation of rapid, easy-to-use, and fully automated nucleic acid testing systems.

“We are very pleased to enter our first clinical trial for the Liat Analyzer,” said Dr. Shuqi Chen, CEO of IQuum. “We look forward to validating the system and providing the US military with the diagnostic system to support our troops deployed overseas, as well the clinical diagnostic market with the tools to improve civilian healthcare.”

Cutaneous leishmaniasis is a sand fly-borne parasitic infection that is prevalent in parts of the Middle East, Africa, and Asia. In the last few years, nearly 1,000 US military personnel have been affected by leishmaniasis in Iraq and Afghanistan, where the disease has been nicknamed “Baghdad Boil.” In response to this disease incidence, the US Army sought out next generation diagnostic tools for detecting leishmaniasis. Current leishmaniasis diagnostics rely heavily on cell culture or microscopy, which is laborious and can take up to two to three weeks to complete. Although PCR based tests have been developed, such tests involve technically complex manual processes and require highly controlled laboratory facilities, thus preventing their use in forward military medical 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.

In order to bring testing closer to troop locations, the Army chose IQuum’s Liat technology to provide an easy-to-use, rapid, and portable solution. The Liat Analyzer conducts all nucleic acid testing steps including target enrichment, inhibitor removal, DNA extraction and real-time PCR detection. Once cleared by the FDA, the Liat Analyzer and Liat Leishmaniasis tests will enable non-specialized military personnel to conduct sophisticated screening for leishmaniasis at forward locations, as well as determine which of the two most prevalent species of Leishmania is present to guide the selection of more appropriate and specific treatment regimens. By providing convenient, reliable and rapid diagnostics, the Liat system will provide significant healthcare and logistics benefits to the US military.

IQuum started development of the leishmaniasis assay in January 2005 under the Department of Defense contract “Nucleic Acid Analyzer for Battalion Aid Station Triage” (contract No. W81XWH-05-C-0061). In phase I of this contract IQuum developed the Liat™ Leish Assay that detects the most common forms of the genus Leishmania. In pre-clinical studies, the Liat Leish Assay achieved a sensitivity of 94% and a specificity of 89%. Detection of the species L. major, L. tropica, L. infantum, L. donovani, L. braziliensis, L. guyanensis, and L. mexicana was shown in pre-clinical testing. Based on these results, IQuum was awarded Phase II of this contract to validate the assays in a human subject trial and submit the results to the FDA for Premarket Notification (510(k)). The trial is being performed in collaboration with Walter Reed Army Institute of Research, as well as other military and civilian sites both in the US and overseas.

“The development of a new, easy-to-use, one hour molecular assay, its integration into the automated Liat Analyzer and the successful completion of pre-clinical testing in only six months is a remarkable accomplishment” said Dr. Chen. “We are very happy with the performance of the system and expect that the Liat Leishmaniasis tests will be the first of many clinical tests to benefit from the sample to result automation of the Liat Analyzer.”

In addition to satisfying the military’s need for improved leishmaniasis diagnostics, the Liat Analyzer is also expected to provide revolutionary benefits to healthcare in general. Indeed, the system’s capabilities are unique in the in vitro diagnostics industry. Its rapid sample-to-result automation facilitates random access testing, which makes diagnostics more efficient and enables hospital labs to streamline workflow. Furthermore, the analyzer’s closed tube design eliminates contamination and allows nucleic acid testing in any setting. As such, hospitals will be able to bring more molecular diagnostics in house without establishing expensive laboratories. In addition, the flexibility of the technology allows the system to adapt to a variety of assays and analytes, ensuring an ever growing test menu and providing a uniform platform for all sample testing needs. Taken together, these advantages will provide clinicians with the information to diagnose and treat patients more effectively and rapidly, and with less cost.

Because of the versatility of the Liat Analyzer, IQuum intends to apply the system broadly across the clinical diagnostic markets, including infectious diseases, cancer markers and predisposition testing. In addition to the Leismaniasis clinical trials, the company plans to enter other clinical trials of its Liat Analyzer within the next year. In this regard, IQuum has recently been awarded a contract from the National Institute of Allergy and Infectious Diseases (NIAID) to prepare a point-of-care sepsis assay for such a trial.

“We are very pleased that the first clinical application of the Liat Analyzer will be one that serves a government need,” Dr. Chen adds. “Indeed, the US government, through multiple grants and contracts from the NIH-SBIR, DOD, and DHS has been IQuum’s partner in developing this enabling technology. Its validation and clearance for marketing will further open the doors to improving healthcare for the population at large.”

For more information about IQuum and the Liat system, please attend the AACC Industry Workshop entitled "1 Hour Molecular Diagnostics in Your Lab” which will provide attendees with an opportunity to get hands-on experience with the Liat Analyzer. The workshop will be held at the Peabody Hotel, Orlando Ballroom II, on July 27, 2005 at 6:00PM. Additional demonstrations will also be available at IQuum’s booth (#735) at the AACC Clinical Lab Expo, where IQuum is also showing its new higher through-put Liat FlowCycler™.

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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