Pocared Diagnostics obtains CE Mark urine test approval

The company is waiting for FDA approval before launching sales

Pocared Diagnostics Ltd. has obtained EU CE Mark certification to market its automated urine test product, which uses light refraction to detect bacteria in samples in real time.

Pocared will apparently not launch European sales immediately, but will wait for US Food and Drug Administration (FDA) approval. The company initiated a clinical trial of the system under FDA protocols in October, and results are due by mid-2012. The company might be able to begin sales by the end of the year.

Pocared is owned by Elron Electronic Industries Ltd. (TASE: ELRN), the life sciences investment arm of Nochi Dankner-controlled IDB Holding Corp. Ltd. (TASE:IDBH), and Vitalife Life Sciences Venture. They consider it one of their more promising portfolio companies, and last year, bought Medtechnica's (TASE: MEDI) stake in it at a company value of NIS 140 million. Elron, Vitalife, and Medtechnica have invested NIS 57 million in the company to date.

Current bacterial diagnostic methods use cultures, which take 48 hours, or chemical tests to identify bacteria, after a large population is present. These tests also require trained laboratory technicians. Pocared's technique is designed to reduce the time needed to obtain test results from 1-2 days to a few minutes. It can also identify the specific bacteria in the urine.

Pocared plans to develop similar automatic diagnostic kits for bacteria in blood, saliva, and phlegm. Many of these tests are currently conducted manually.

Previous attempts to launch automated urine diagnostic tests in the US failed in marketing, so Pocared currently has no direct competitors in this market. The company already has an insurance indemnification code that will allow higher indemnification than for manual tests.

Published by Globes [online], Israel business news - www.globes-online.com - on January 3, 2012

© Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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