Description

Chembio Diagnostics develops and manufactures rapid tests to aid in the detection of infectious diseases, including HIV and tuberculosis.

Products/Services

Chembio Diagnostics offers rapid tests for HIV in two formats: Sure Check HIV and HIV Stat-Pak. Both products are single-use diagnostic tests for rapid, visual detection of the HIV virus antibodies.

Technology

The company's Sure Check HIV and HIV Stat-Pak rapid tests are easy to use as they require neither electricity, nor expensive equipment for test execution or reading, nor skilled personnel for test interpretation. The test is fast, with a turn around time of less than 15 minutes; safe, as the convenient strip format minimizes handling of potentially infected specimens; non-invasive, as it only requires 5 ul of serum or whole blood easily obtained with a finger prick; stable, as it can keep at least 18 months without refrigeration; and highly reproducible.

Market/Customers

By the end of 2007 there were approximately 33.2 million people living with HIV/AIDS including 15.4 million women and 0.42 million children under the age of 15. The company sells its tests in the U.S. and internationally to medical laboratories and hospitals, governmental and public health entities, non-governmental organizations, medical professionals and retail establishments.

Strategy

In October 2006, Chembio announced a marketing partnership with Inverness Medical Innovations for its rapid HIV tests. Inverness and Proctor & Gamble recently announced a joint venture through which Chembio believes P&G would market an HIV test developed by Chembio for the OTC market. In April 2008, the company signed an exclusive development agreement with Bio-Rad Laboratories to develop a multiplex test employing Chembio's Dual Path Platform test system.

Status

Chembio Diagnostics, Inc. has received a CLIA Waiver for its FDA-approved HIV Barrel test. A CLIA waiver greatly expands the available potential U.S. market opportunity for a product from sites that require much greater certification and oversight to additional venues where point-of-care testing is particularly beneficial.