SpectraDigital Corporation to Begin Phase 1 Pilot of HIV Diagnostic Tool: Initiation of First US Clinical Trial for HIV SpectraPoint"(tm) Assay.

SpectraDigital Corporation, has begun a Phase I clinical pilot of its HIV SpectraPoint diagnostic system with AIDS ReSearch Alliance of America (ARA). Up to 40 patients will receive a standard phenotype test as well as the antiviral efficacy test generated by the new HIV SpectraPoint assay. The system could allow physicians to receive results within 24 hours, allowing essential treatment decisions to be made before the virus can develop new, unseen resistance patterns.

GUELPH, ONTARIO (PRWEB) November 9, 2004 -- SpectraDigital Corporation, a privately held diagnostic company, announced today that it has begun a Phase I clinical pilot of its HIV SpectraPoint diagnostic system.

The study will take place at AIDS ReSearch Alliance of America (ARA) in West Hollywood, California. The Principal Investigators of the trial will be ARAs Medical Director, Stephen J. Brown, M.D., and ARA's Director of Scientific Communications Marjan Hezareh, Ph.D. This is SpectraDigitals first U.S.-based clinical study of the HIV SpectraPoint system.

The double blind, controlled trial, which is currently enrolling patients, is expected to be completed by the end of the year. In total, an analysis involving up to 40 HIV positive patients will be performed. Each patient will receive a standard phenotype test, an increasingly common tool in the treatment of HIV that can help physicians determine which drugs may no longer be effective against the predominant strain in an HIV-infected person. The same forty subjects will also receive another antiviral efficacy test generated by the new HIV SpectraPoint assay. If the new system works as planned, physicians could have the results of this rapid diagnostic test within 24 hours. This, in turn, allows essential treatment decisions to be made before the virus can develop new, unseen resistance patterns.

The hope is that in many cases patients will receive real clinical benefit from rapidly available data supplanting the traditional time window of weeks, and that HIV clinicians will have at the same time a more accurate snapshot" of their patients HIV disease.   

This pilot study represents an important step in the development of our HIV diagnostics solutions," said SpectraDigital President Satish Deshpande. In addition to our primary objective of comparing HIV SpectraPoint to a standard phenotypic resistance assay, we also will determine the ability of our system to detect resistance among individuals with viral loads well below the limit of detection of traditional assays."

Irl Barefield, Executive Director of ARA added, "HIV SpectraPoint represents the possibility of advancing HIV diagnostics by providing useful data for interpreting antiviral efficacy more rapidly than ever thought possible. The relative ease and lower cost of the test also make it likely that patients would be monitored more frequently, enhancing their clinical options."

About SpectraDigital Corporation:
SpectraDigital Corporation (SDC) is a privately owned diagnostics company based in Guelph, Ontario. SDCs core competency is the development and application of cell-based technologies to resolve various problems in drug development, environmental monitoring, and medical diagnostics.    

For further information about SpectraDigital Corporation:

For further information contact Irl Barefield, Executive Director, at (310) 360-3860. Extensive information is also available at www.AIDSRESEARCH.org.

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