FDA clears the White IRIS for white blood cell classification.

CHATSWORTH, Calif.--(BUSINESS WIRE)--May 21, 1996--International Remote Imaging Systems Inc. (ASE:IRI), manufacturer and marketer of fast, efficient and accurate automated diagnostic equipment, including The Yellow IRIS urinalysis workstation, announced it has obtained clearance from the Food and Drug Administration (FDA) to commence marketing The White IRIS leukocyte differential analyzer, its newly developed workstation for white blood cell classification.

The FDA cleared the The White IRIS as a class III device for commercial use in the classification of normal as well as immature and other abnormal types of white blood cells.

Current state-of-the-art hematology analyzers can accurately classify only four or five mature types of white cells and only in blood specimens in which white blood cell compositions fall within normal ranges.

Usually 15% to 60% of all specimens, depending on the laboratory's patient population, require additional review by manual microscopic examination of stained blood smears, a labor-intensive and often imprecise procedure. In replacing the manual method, The White IRIS provides greater accuracy and precision and saves substantial time.

Key to the ability of The White IRIS to classify a wide variety of white blood cells is the unique series of expressions of 2-methlypolymethine (2-MPM), a new and patented cytoprobe for which IRIS owns the exclusive worldwide license, as well as patented novel color descriptors and classification algorithms developed by IRIS scientists based on the color reactions of the 2-MPM cytoprobe.

Using The White IRIS, a trained technologist can complete a differential of 500 white blood cells in as little as 20 seconds vs. four to 15 minutes for the traditional 100 cell manual procedure.

According to Dr. Harvey L. Kasdan, IRIS vice president of research and development and leader of the IRIS team of scientists that developed The White IRIS: "Comparative trials have shown that the new system provides white cell classification performance superior to today's commercial hematology analyzers and offers the potential to serve as a quantitative standard against which the accuracy of these instruments can be objectively measured for the first time."

The White IRIS also offers significant benefits in patient care, cost reduction and medical technologist safety and is expected to compete directly with the Micro 21 slide reader, a system based on slide-based methodology introduced recently by Intelligent Medical Imaging Inc. The company plans to install the new system at a number of strategic locations later this year as a prelude to more intensive sales and marketing.

IRIS, a Los Angeles-based company, manufactures and markets The Yellow IRIS urinalysis workstation to clinical laboratories nationwide. The company is the recognized leader in automated microscopic urinalysis with The Yellow IRIS in use in more than 75 percent of hospitals affiliated with U.S. medical schools and other leading hospitals. IRIS expects The White IRIS to serve as the foundation of its second major product line based on the application of its proprietary slideless microscopy and rapid image processing technology.

The company recently reported record earnings and revenues for the first quarter of 1996, following a sixth consecutive record year in 1995. IRIS acquired StatSpin Technologies in February of 1996, resulting in combined revenues of more than $16 million last year.

CONTACT: International Remote Imaging Systems Inc., Chatsworth

Harvey L. Kasdan, 818/709-1244

or

ECOM Consultants

Noah Fields, 212/696-1133