Guava Technologies Announces FDA 510(k) Clearance of Guava® EZCD4 System for CD4 Monitoring

Guava Technologies, Inc today announced that Guava has received 510(k) clearance from the U.S. Food and Drug Administration for the Guava® EZCD4 System, which includes the EZCD4 Assay, the PCA Instrument and CytoSoft v2.3 Software, incorporating three modules (EZCD4, Guava Check and Clean and Shutdown).

The EZCD4 System is intended to identify and quantify absolute counts of CD4+ T-Lymphocytes in EDTA whole blood. Utilizing Guava’s easy-to-use and cost-effective Microcapillary Cytometry Technology, the Guava EZCD4 System is intended for the ongoing monitoring of patients with documented diagnosis of an immunodeficiency disease.

Absolute counts of CD4+ T-cells can be useful in characterizing, monitoring and evaluating the effectiveness of treatment for autoimmune and immunodeficiency diseases. Determining the number of CD4+ T-cells can be useful in monitoring human immunodeficiency virus (HIV)-infected individuals.

The Guava® EZCD4 Assay is a two-color, direct immunofluorescence reagent kit intended for use with a Guava PCA System. The kit consists of a monoclonal anti-human CD3 antibody that uniquely identifies T-cells and a monoclonal anti-human CD4 antibody that allows the identification of human helper/inducer CD4+ T-cells (HLA Class II reactive).

Lawrence Bruder, Guava Technologies' Chief Executive Officer, stated, "It is an important milestone for Guava to receive FDA clearance on the EZCD4 assay system based on our proprietary Microcapillary Cytometry Technology. This enabling technology provides our customers with reliable and robust measurements using smaller samples and fewer reagents than other systems in the market. In addition to the very necessary diagnostic application of monitoring immuno-compromised patients, we believe the Guava system provides an ideal approach for combining powerful cell analysis with healthcare systems struggling to conserve resources in personnel and equipment.”

Guava Technologies' Microcapillary Cytometry Technology enables the EZCD4 System to be highly compact, portable and low maintenance. Testing requires only 10 microliters of whole blood per patient. The Guava EZCD4 System also requires far less reagent per sample, dramatically lowering the overall costs of performing the assay. Moreover, the microcapillary technology does not require the use of sheath fluid, large amounts of which are typically needed for conventional flow cytometers. The elimination of sheath fluid results in less bio-hazardous waste and further reduces the running costs of the system. Daily maintenance is minimal, requiring a short clean and shutdown procedure performed at the end of each day.

“We are very excited about the FDA clearance as this validates the capabilities of our technology,” said Lalit Dhir, Guava Technologies’ VP of corporate development and strategic marketing. “This will allow us to work with partners who are interested in leveraging our platform’s unique advantages of ease of use and smaller sample requirements for the development of breakthrough diagnostics for a wide variety of clinical applications.”