Infectious Diseases
Researchers diagnose flu with gold nanoparticles
A new influenza-detection method has been developed at the University of Georgia and detailed in the August edition of the journal Analyst. By coating gold nanoparticles with antibodies that bind to specific strains of the flu virus and then measuring how the particles scatter laser light, the technology can detect influenza in minutes at a cost of only a fraction of a penny per exam. “We’ve known for a long time that you can use antibodies to capture viruses and that nanoparticles...
Roche to Provide HIV/AIDS Tests for Early Infant Diagnosis in South Africa
Roche has been awarded an exclusive contract by the National Health Laboratory Services (NHLS) in South Africa for the support of the Early Infant Diagnosis (EID) Programme. Roche will deliver diagnostics to support the largest infant testing initiative in the world that aims to identify HIV-infected children during the first months of life. Infants can be tested with Roche’s diagnostics using the Dried Blood Sampling (DBS) technique, with which a spot of blood is preserved on filter...
Chembio Initiates Pre-IDE Studies for Home Use Rapid HIV Test
Chembio Diagnostics Inc. has initiated studies required for submission of an Investigational Device Exemption (IDE) to FDA for its Sure Check rapid HIV Test as the first step toward over-the-counter (OTC) product approval. This is the first of Chembio's FDA-approved rapid HIV tests that it will target for the at-home market. The first step toward approval is to submit an investigational device exemption (IDE). Chembio believes that a market study of the intended users and an additional "...
Luminex to Acquire EraGen Biosciences
Luminex Corp. announced a definitive agreement to acquire privately-held EraGen Biosciences Inc. Under the terms of the agreement, Luminex will purchase all outstanding shares of EraGen for approximately $34 million in cash, subject to certain adjustments. The transaction is anticipated to close within the next several weeks. The acquisition of EraGen Biosciences provides Luminex with access to a highly complementary portfolio of molecular diagnostic assays based on an innovative and...
Roche Applied Science, TIB Molbiol Offer Assay Solution for Rapid EHEC Identification
With the recent outbreak in Europe of Enterohaemorrhagic Escherichia coli (EHEC), Roche Applied Science and TIB Molbiol are providing scientists with complementary technologies that can be used for the rapid identification and detection of EHEC. Fast, reliable detection of the EHEC bacterium is essential for monitoring and controlling EHEC infections. The most appropriate targets for the rapid, sensitive identification of the EHEC bacterium are unique genetic sequences, which can be amplified...
Immunetics Awarded $2.4M NIH Grant for Clinical Trials of New Chagas Test
Immunetics Inc. has been awarded a $2.4 million, 3-year Phase II SBIR grant by the National Institute of Allergy and Infectious Diseases, a division of NIH, to support clinical trials of the company's new confirmatory test for Chagas’ disease. Existing screening tests that detect antibodies to the parasite are frequently inaccurate. A complex method called radioimmunoprecipitation (RIPA) is sometimes used to confirm screening test results, but is beyond the reach of most laboratories....
American Academy of HIV Medicine Hails Pennsylvania Senate's Passage of HIV Testing Bill
The American Academy of HIV Medicine (AAHIVM) praised the Pennsylvania State Senate for the passage of legislation sponsored by state Sen. Ted Erickson (R-26) that reduces barriers to routine HIV testing. The passage of Senate Bill 260 eliminates burdensome requirements for separate written consent and pre-test counseling in order to obtain an HIV test and brings Pennsylvania state law on HIV testing more in line with current recommendations from CDC. Currently, Pennsylvania is one of only five...
Quest Diagnostics Tests for Epstein Barr, BK Viruses Get CE Marks
Quest Diagnostics Inc. announced that two new Simplexa-branded molecular test kits developed by its Focus Diagnostics business have been CE marked for distribution to approximately 35 countries in Europe. The test kits, designed to enable hospital labs to perform advanced molecular testing for Epstein-Barr (EBV) and BK viruses, are the first products from the Simplexa line to aid in the clinical management of patients with compromised immunity. Simplexa tests, running on the 3M Integrated...
Cepheid Receives FDA Clearance for Flu Test
Cepheid has received clearance from FDA to market Xpert Flu. The diagnostic test, which runs on Cepheid's GeneXpert System, simultaneously detects and differentiates Influenza A, Influenza B, and the 2009 H1N1 influenza virus in about one hour. "With Xpert Flu, Cepheid delivers another fast, accurate, and easy-to-use diagnostic test that detects the major influenza strains in circulation," said John Bishop, Cepheid's Chief Executive Officer. "While molecular testing is widely...
Biomagnetics, Los Alamos National Laboratory Agreement Produce Validated Tuberculosis Assay
Biomagnetics Diagnostics Corp. has completed a series of payments to Los Alamos National Laboratory (LANL) pursuant to the cooperative research and development agreement (CRADA) executed in 2010 between the two organizations. To date for the CRADA, LANL has constructed a new benchtop type waveguide-based biosensor system, developed a validated assay for a Tuberculosis biomarker, evaluated multiple assays developed using the benchtop system specifically built for Biomagnetics, and is working on...