StatSure Diagnostic Systems, Inc. (SDS) is engaged in the business of marketing its patented Point-of-Care (POC) diagnostic test for the detection of HIV 1/ 2. The SDS HIV 1/ 2 diagnostic test is manufactured in the U.S by Chembio Diagnostics (OTC: CEMI), is FDA approved and CLIA waived and is sold in the U.S. to clinics, hospitals and physicians by Alere (NYSE: ALR) (formerly Inverness Medical) under the brand name Complete HIV 1/ 2. The test has become very popular particularly to Public Health administrators as it is very easy to use and uses only 2.5? of blood. Since SDS has introduced its HIV rapid test product, its annual sales have shown very rapid growth. As more public health agencies come off contract many are choosing the SDS test.
SDS is ready to take its HIV test to the next level.
SDS is applying for FDA approval to market its test in the consumer market as an OTC product. The estimated market for a consumer HIV test is between 30-100 Million tests annually. The entry to market is long and tedious and to date SDS has only one competitor Orasure (NASD: OSUR). Management believes that SDS unique patented “Barrel Test” format which is easy to use, needs only 2.5? of blood (a fingerprick) and is designed specifically for consumers will become the consumer test of choice.