• ExonHit Therapeutics (Paris) reported completion of a prototype of the first blood-based Alzheimer’s disease test. The company said it expects to have the test certified and to provide it as a service in its GLP- (Good Laboratory Practices) compliant laboratories to the pharmaceutical industry as early as 2009. This initial ExonHit test aims to identify patients suffering from Alzheimer’s disease from a simple blood sample. This test is based on hybridizing nucleic acids (RNA), isolated from a blood sample, on a custom microarray produced by Affymetrix which contains sequences identified using ExonHit’s patented human genome screening technology. The blood test can distinguish patients suffering from Alzheimer’s disease from those suffering from bipolar disorders, schizophrenia or depression. The identified sequences (or “signature”) were found to be typical in the blood of patients suffering from Alzheimer’s disease can be grouped and are representative of alterations of well known metabolic functions.

• Innovative Biosensors (Rockville, Maryland) said that it has launched the BioFlash biological aerosol collection, detection and identification system. The BioFlash is rugged, portable, and incorporates a high-volume aerosol sampler. The well-integrated technology provides rapid, specific and sensitive detection of 21 biological threat agents in single test or multi-test formats within minutes. BioFlash can be implemented in various scenarios including military force protection, facility security management, as well as field detection/identification and environmental monitoring. Innovative Biosensors is a privately held company developing technologies for the rapid detection of pathogens in biodefense applications and human clinical diagnostics.

• Pathwork Diagnostics (Sunnyvale, California) said that its Pathwork Tissue of Origin Test is the focus of two studies featured in poster presentations at the 12th Annual Meeting of the Association for Molecular Pathology. The new genomics-based test is designed to help determine a tumor’s origin so that tissue-specific management can begin. The test’s proprietary analytics are designed to measure the expression of more than 1,600 genes and compare a tumor’s genetic “signature” against those of 15 known tissue types. The test uses microarray technology, which enables large numbers of genes to be evaluated at the same time, using the Affymetrix instrument system. Pathwork is a genomics-based diagnostics company focused on oncology.

• Rapid Pathogen Screening (RPS; Sarasota, Florida) reported that the American Medical Association will issue a new current procedural terminology (CPT) code that will cover the RPS Adeno Detector, effective Jan. 1, 2008. CPT Code 87809 — a code for “Infectious agent antigen detection by immunoassay with direct optical observation; Adenovirus” — will cover the RPS Adeno Detector, a point-of-care test available for conjunctivitis (pink eye). Rapid Pathogen Screening makes point-of-care diagnostic devices for ocular diseases.

• StatSure Diagnostic Systems (Framingham, Massachusetts) said that the FDA has approved a waiver under the Clinical Laboratory Improvements Amendments of 1988 (CLIA) for an HIV 1/2 rapid test employing the company’s patented “barrel” technology. The HIV 1/2 product is marketed and distributed worldwide by Inverness Medical Innovations (Waltham, Massachusetts) under its Clearview brand as Clearview Complete HIV 1/2. Specifically, the test has been waived for use in detecting HIV-1 and HIV-2 antibodies in human whole blood, serum, and plasma and demonstrates a sensitivity of 99.7% and a specificity of 99.9% in clinical trials. StatSure Diagnostic Systems makes rapid immunoassay tests for the detection of sexually transmitted and other infectious diseases.

• SunTech Medical (Morrisville, North Carolina) reported the release of the SunTech 247 diagnostic station. The company said the device “bridges the gap in price and capability between manual blood pressure gauges and vital signs monitors.” It is available in the U.S. exclusively through IMCO and NDC members and worldwide through SunTech authorized distributors. The SunTech 247’s modular design allows the addition of temperature and SpO2 modules and is available in a variety of mounting configurations, including wall, table or mobile stand. SunTech Medical makes blood pressure technology equipment.