Biocept and Clarient to collaborate on blood test for CTCs
Biocept, Inc., a privately-held CLIA-certified laboratory testing company, and Clarient, Inc. (a GE Healthcare Company) say that they will be collaborating on the commercialization of a proprietary blood test for circulating tumor cells (CTCs) in breast cancer patients, which includes the determination of HER2 status. They will also market and sell Biocept’s new OncoCEE-BR™ CTC test to community hospitals, pathologists and medical oncologists. Biocept will perform the test in its laboratories, and results will be interpreted by Clarient Pathology Services, Inc. The test includes CTC enumeration and HER2 status of the detected CTCs by fluorescence in situ hybridization (FISH); it is the first commercially available CTC test to include analysis of a specific treatment-associated biomarker.
The OncoCEE™ platform, developed by Biocept, has demonstrated that it can consistently and accurately capture extremely rare cells from blood, like CTCs, which may be present in only 1 of every 50-100 billion blood cells.
IQuum receives FDA 510(k) clearance for influenza molecular diagnostics
Marlborough, Mass.-based IQuum, Inc. reported that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Liat™ Influenza A/B Assay and the Liat™ Analyzer. This molecular diagnostic test is an automated sample-to-result multiplex real-time RT-PCR assay for the detection and discrimination of influenza A and influenza B in approximately 20 minutes. The test is intended for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform “moderate complexity” tests, enabling its use in hospital labs or other near-patient settings. The Liat system integrates multiple intelligent features, such as sample volume metering, on-board internal control, advanced error diagnostics, and automated data interpretation. The Liat Analyzer automatically executes all the required assay steps and reports test results on the built-in touch screen. No manual reagent addition, operator intervention or data interpretation is required.
Phadia AB launches high capacity allergy testing instruments
Phadia has launched the Phadia 2500 and Phadia 5000, new high capacity instruments offering the possibility to combine allergy and autoimmunity testing. The Phadia 2500 allows laboratories to deliver up to 25 000 results per week and up to 50 000 results when using Phadia 5000. Both instruments are flexible with the possibility to assay more than 600 allergens and 80 allergen components in combination with an autoimmunity antigen panel optimized for evaluation of over 20 autoimmunity disorders.
CAE Healthcare acquires METI
Montreal-based CAE Healthcare has acquired METI for US$130 million. The deal helps CAE Healthcare expand its product and services offering in simulation-based technology for healthcare. The family of METI simulators, including baby, pediatric and adult, are designed to mimic human medical scenarios including trauma, heart attack, drug overdose and effects of bioterrorism. The company’s revenues currently exceed US$60 million and approximately 6,000 METI simulators are in use worldwide by medical schools, nursing schools, hospitals, defense forces and other entities involved in healthcare education and training.
CAE reported that it has issued US$150 million of senior notes in a private placement to fund the METI acquisition and to replace other existing obligations at lower interest costs. -Peter Winter