STATSURE DIAGNOSTIC SYSTEMS, INC.

STATSURE DIAGNOSTIC SYSTEMS, INC.

Previous company name
SALIVA DIAGNOSTIC SYSTEMS, INC.
Name change date
1/24/2006
Company Overview
StatSure Diagnostic Systems, Inc. is an American-based company engaged in the development, manufacture, and marketing of patented rapid point of care testing device for infectious diseases, as well as oral fluid specimen collection devices using a patented volume adequacy indicator for drugs of abuse testing and other clinical uses. The company, with headquarters located in Framingham, Massachusetts, was founded in 1986 and was formerly known as Saliva Diagnostic Systems, Inc. In 2006, the company changed its name to StatSure Diagnostic Systems, Inc.
StatSure Diagnostic Systems is primarily involved in the production of oral-fluid collection devices to provide physiologic samples to screen for the presence of drugs-of-abuse or infectious diseases; and the development of point-of-care, rapid, immunoassays for use in the detection of infectious diseases. The company markets its oral-fluid collection devices under the trade names Omni-SAL and Saliva-Sampler in the United States, the United Kingdom, and other international markets. StatSure Diagnostic Systems markets its products to the workplace testing, forensic toxicology, criminal justice, and drug rehabilitation markets primarily through distributors. The company also owns the StatSure Hemastrip patent.
Business Summary
StatSure Diagnostic Systems, Inc. (SDS) is primarily engaged in commercializing two product platforms: the development, manufacturing and marketing of oral-fluid collection devices to provide physiologic samples to screen for the presence of drugs-of-abuse or infectious diseases, and the development of point-of-care (POC) immunoassays for use in the detection of infectious diseases. As part of a three-way alliance with Inverness Medical Innovations, Inc. and Chembio Diagnostics, SDS signed a worldwide, distribution deal for a point-of-care human immunodeficiency virus (HIV) test with Inverness. In a two-way deal with Chembio, the Company granted a license to Chembio solely to manufacture their United States Food and Drug Administration (FDA)-approved HIV barrel product for Inverness Medical Innovations. This product is being marketed under the IMA brand.
Description and history
StatSure Diagnostic Systems, Inc. (SDS) is primarily engaged in commercializing two product platforms: the development, manufacturing and marketing of oral-fluid collection devices to provide physiologic samples to screen for the presence of drugs-of-abuse or infectious diseases, and the development of point-of-care (POC) immunoassays for use in the detection of infectious diseases. As part of a three-way alliance with Inverness Medical Innovations, Inc. and Chembio Diagnostics, SDS signed a worldwide, distribution deal for a point-of-care human immunodeficiency virus (HIV) test with Inverness. In a two-way deal with Chembio, the Company granted a license to Chembio solely to manufacture their United States Food and Drug Administration (FDA)-approved HIV barrel product for Inverness Medical Innovations. This product is being marketed under the IMA brand. On November 5, 2007 the Company announced that the FDA, through its Center for Devices and Radiological Health, had approved a waiver under the Clinical Laboratory Improvements Amendments of 1988 (CLIA) for the HIV 1/2 Rapid Test marketed by Inverness, as per the aforementioned agreement.

Rapid Point-Of-Care (POC) Immunoassays

The Company has developed several rapid tests utilizing immunochromatography for the detection of antibodies to selected pathogens, including a test for HIV, which the Company has licensed to Inverness. The StatSure branded barrel format is a disposable, single-use test-kit that collects, processes, and analyzes whole-blood, plasma, or serum with approximately 2.5 microliters of sample. Sample collection requires only a few seconds, typically from a finger-stick using a lancet. When utilizing this product with whole-blood, a filter traps red blood cells from the-whole blood sample permitting the migration of serum to flow onto the strip, thereby negating the need for the user to centrifuge a specimen to separate serum from the whole blood sample.

Oral Fluid Collection Devices

SDS markets its saliva medical specimen collector in the United Kingdom as Omni-SAL and as Saliva-Sampler in the United States. It is being sold by the Company’s customers to use with certain laboratory assays primarily to detect the presence of drugs-of-abuse. It has also been used to detect cigarette smoking, and in research, to collect saliva samples for studies of HIV and other infectious diseases.

The Company competes with Orasure Technologies, Inc.

Formerly known as Saliva Diagnostic Systems, Inc

Business Line
Engaged in the development, manufacture, and marketing of patented rapid point of care testing device for infectious diseases, as well as oral fluid specimen collection devices using a patented volume adequacy indicator for drugs of abuse testing and other clinical uses
Subsidiary

Advisor
LAZAR LEVINE & FELIX LLP
IPO date
3/1993
US SIC Code
3841
Company Address
1222, Avenue M

City province or state postal code
11230, BROOKLYN, NY
Phone: +1 347 394 3641
Fax:
Country address: UNITED STATES OF AMERICA
Website url: www.statsurediagnostics.com