Diagnostics Product Guide » Molecular Diagnostics

Siemens Leads By Example In IVD Industry Through Adopting GS1 Standards For Healthcare Product Identification

admin — Fri, 24 Sep 2010 15:02:58 +0000

Siemens Healthcare Diagnostics has published product data including GTINs for its complete U.S. product portfolio to the GHX Health ConneXion™ data pool, which is certified by GS1′s Global Data Synchronization Network (GDSN) to synchronize medical-surgical product data. The GS1 system of standards is the most widely used supply chain standards system in the world. Use of standards has proven highly effective in other industries, such as retail and consumer packaged goods.

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Roche Receives FDA Clearance For U.S. Launch Of Cobas 8000 Modular Analyzer Series For High-Volume Laboratory Testing

admin — Tue, 14 Sep 2010 15:03:32 +0000

Roche Diagnostics announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the cobas® 8000 modular analyzer series, a Serum Work Area solution designed for diagnostic laboratories with a workload of 3-15 million clinical chemistry / immunochemistry tests per year. The cobas 8000 series is the newest member of the Roche cobas modular platform family, which combines clinical chemistry and immunochemistry testing.

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ForteBio Announces Launch Of Protein G Biosensor For Use On its Octet(R) Instruments

admin — Fri, 10 Sep 2010 05:20:48 +0000

ForteBio®, Inc. announced the launch of its Dip and Read™ Protein G biosensor for rapid detection and quantification of numerous types of mammalian immunoglobulin (IgG), an antibody molecule, from solution. Because it runs on the company’s label-free Octet instrumentation platform, the new biosensor enables such measurements with unprecedented speed, ease of use and cost-efficiency. The company also announced that it has completed International Standards Organization (ISO) certification of its biosensor manufacturing facility.

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First HIV diagnostic assay approved

admin — Tue, 20 Oct 2009 07:26:29 +0000

Ortho Clinical Diagnostics received the FDA approval of a diagnostic assay for the detection of antibodies to human immunodeficiency virus (HIV) types 1+2 (Anti-HIV 1+2) for use on the VITROS® 5600 Integrated and VITROS® 3600 Immunodiagnostic Systems. This is the first HIV diagnostic assay approved for an integrated system in the US, allowing laboratories to run HIV and other routine tests on a single testing platform and eliminating the need for expensive batch testing of multiple patient samples.

HemoPoint H2 Hemoglobin DMS of Stanbio approved

admin — Tue, 07 Jul 2009 05:26:33 +0000

Stanbio Laboratory announced that the FDA has approved its HemoPoint H2 Hemoglobin Data Management System (DMS), which provides both a hemoglobin and calculated hematocrit result with one simple test. The new, HemoPoint H2 DMS utilizes connectivity to PCs via Bluetooth, control intervals and barcode identification of operators and patients to offer time-saving convenience, ease of data management technology and high quality control.

Asuragen Initiates Launch of CE-Marked Molecular Diagnostic Products

admin — Tue, 09 Dec 2008 06:27:14 +0000

Asuragen, Inc. has announced that the Signature(R) LTx v2.0 Leukemia Translocation Panel was released as a “Conformite Europeenne” or “European Conformity” CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. The CE-marked Signature(R) LTx v2.0 is a qualitative in vitro diagnostic device for use in a clinical laboratory to identify specific fusion transcripts in total RNA from whole blood or bone marrow to aid in the clinical diagnosis of translocation positive leukemias. Clinical validation studies showed 100% diagnostic accuracy in comparison to standard cytogenetic methods. This represents the world’s first Luminex-based molecular oncology IVD product.

FDA approval to GE Healthcare’s AdreView™

admin — Thu, 25 Sep 2008 08:59:30 +0000

The U.S. Food and Drug Administration (FDA) has approved GE Healthcare’s molecular imaging agent AdreView™ (Iobenguane I 123 Injection) for the detection of rare neuroendocrine tumors in children and adults. The product provides images of high quality that assist physicians in the detection of tumors, at the initial stage as well as at the time when relapse is suspected. AdreView™ marks an advancement in diagnosis of cancer patients suffering from neuroblastoma. It will also identify primary and metastatic pheochromocytoma.

Pathway Diagnostics launches SensiTrop II assay

admin — Thu, 15 May 2008 16:23:08 +0000

Pathway Diagnostics has released its patented, second-generation SensiTrop II assay for HIV-infected patients. The product combines the sensitivity of molecular heteroduplex tracking assay technology with molecular sequencing to determine the CCR5 co-receptor tropism status of patients, according to Pathway. It provides clinicians a fast, accurate, sensitive and economical testing alternative to biological HIV tropism assay.