July 23, 2014 10:31 PM ET

Biotechnology

Company Overview of Intelligent Medical Devices, Inc.

Company Overview

Intelligent Medical Devices, Inc., also known as IntelligentMDx, designs, develops, and manufactures molecular diagnostic testing products for targets in infectious diseases, oncology, and genetics. It offers IMDx C. difficile assay for the Abbott m2000, an in vitro polymerase chain reaction (PCR) assay for the detection of toxigenic C. difficile toxin A and B genes in human liquid or soft stool specimens from patients with symptoms of C. difficile associated disease. The company also provides IMDx VanR for Abbott m2000 assay, an in vitro PCR assay for the detection of nucleic acids encoding vanA and vanB vancomycin resistance genes directly from human peri-rectal or rectal swabs or stool sa...

19 Blackstone Street

Cambridge, MA 02139

United States

Founded in 2004

Phone:

617-871-6400

Fax:

617-871-6399

Key Executives for Intelligent Medical Devices, Inc.

Senior Director of Operations
Senior Vice President and General Counsel
Vice President of Human Resources
Compensation as of Fiscal Year 2014.

Intelligent Medical Devices, Inc. Key Developments

IntelligentMDx Obtains CE Mark Approval for its Artus C. Difficile QS-RGQ Kit

IntelligentMDx announced that it has obtained CE Mark approval for its artus C. difficile QS-RGQ kit for use with QIAsymphony SP/AS and Rotor-Gene Q instruments. This is the first of a series of assays designed, developed, and manufactured by IMDx for Qiagen under a multi-year development and license agreement. IMDx's artus C. difficile QS-RGQ kit detects the presence of Clostridium difficile (C. difficile), the most common cause of hospital-associated diarrhea. The kit detects C. difficile in human liquid or soft stool from patients suspected of having C. difficile-associated disease. The test is intended to be used directly on patient samples to help in diagnosis of C. difficile infection.

IntelligentMDx Receives FDA Clearance for IMDx C. difficile for Abbott m2000 Assay; Completes Move of Corporate Headquarters to Waltham

IntelligentMDx announced that it has received FDA clearance for the IMDx C. difficile for Abbott m2000 assay which detects nucleic acids encoding the toxin A gene and toxin B gene sequences of toxigenic strains of Clostridium difficile in human liquid or soft stool specimens collected from patients suspected of having Clostridium difficile associated disease. This is the third test from IMDx to receive FDA clearance within three months for use on Abbott's fully-automated m2000 system and follows clearances of the IMDx VanR for Abbott m2000 and IMDx Flu A/B and RSV for Abbott m2000 assays. C. difficile is the cause of hospital-acquired diarrhea and may cause more severe intestinal conditions such as pseudomembranous colitis. According to the CDC, C. difficile infection is linked to approximately 14,000 deaths in the United States annually. Effective molecular diagnostic tests for early detection of C. difficile remain critical to help control the spread of infection and the threat of more serious complications. Analytical reactivity studies demonstrated that the IMDx C. difficile for Abbott m2000 assay is capable of detecting the 31 different toxigenic C. difficile strains that were tested. These strains represent the global diversity of C. difficile strains, including NAP1, and tcdB-variant strains, such as 1470. The IMDx C. difficile for Abbott m2000 assay is part of a broad real-time PCR test menu designed, developed, and manufactured for use on Abbott's RealTime m2000 system under a multi-year distribution agreement with Abbott. IMDx also recently completed the move of its corporate headquarters, manufacturing and R&D operations to its new facility in Waltham, Massachusetts. The design-built facility features BL-2 laboratory space and GMP manufacturing in compliance with FDA and ISO 13485 standards.

IntelligentMDx Receives FDA Clearance for IMDx Flu A/B and RSV for Abbott m2000 Assay

IntelligentMDx announced that the U.S. Food and Drug Administration (FDA) has cleared its automated molecular diagnostic test that detects influenza A, influenza B, and Respiratory Syncytial Virus (RSV) directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This is the second test from IMDx's portfolio of molecular diagnostic products to be cleared by the FDA for use on Abbott's fully automated m2000 platform and is IMDx's second FDA clearance in five weeks. The IMDx VanR for Abbott m2000 test, which detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE), received clearance in July 2013. Influenza and RSV infections cause a great health burden on the US population with as many as 60 million individuals becoming infected with influenza each year and approximately 125,000 children under the age of 1 being hospitalized annually with RSV infection. Influenza and RSV manifest similarly; symptomatic patients may experience fever, chills, headache, weakness, sneezing, runny nose, sore throat, and/or a cough. More severe complications including pneumonia and secondary bacterial or viral infections may also occur if infection with influenza and/or RSV is not properly treated. Reactivity studies demonstrated that the IMDx Flu A/B and RSV for Abbott m2000 assay is capable of detecting multiple influenza A/B and RSV strains from various geographical locations, including H1N1, H3N2, and recently emerging H3N2 variant strains. This assay can produce results for up to 94 patient samples simultaneously.

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