Health Canada has approved Roche's fully automated test, designed to assess a patient's viral load of cytomegalovirus (CMV). The COBAS AmpliPrep / COBAS TaqMan CMV assay is the first approved test, which is standardized to the WHO ...
Tags: Health Canada, CMV, clinical trial
The US Food and Drug Administration (FDA) has approved Roche's new COBAS TaqMan HIV-1 viral load test. The HIV viral load test utilizes the FDA-approved high pure system viral nucleic acid kit for manual specimen preparation and the COBAS ...
Tags: HIV-1 viral load test, COBAS TaqMan, FDA
Astellas Pharma US is seeking FDA approval for Tarceva tablets to treat non-small cell lung cancer patients (NSCLC) with tumors containing epidermal growth factor receptor (EGFR) that triggers mutations. The company submitted a ...
Molecular diagnostics company Exact Sciences has submitted to the US Food and Drug Administration(FDA)the first module of the premarket approval(PMA)application for its stool DNA colorectal cancer screening test. The first modular ...
Tags: molecular diagnostics, Exact Sciences, PMA application
The US Patent and Trademark Office (USPTO) will issue Patent No. 8,340,916 to Sequenom for its application covering methods of detecting fetal aneuploidy. The patent, which will be issued on 25 December 2012, covers claims related to ...
Tags: Sequenom, US patent, fetal aneuploidy, USPTO
HTG Molecular Diagnostics has partnered John Wayne Cancer Institute (JWCI) to sell its HTG melanoma signature assays. The signature assays are intended to be useful for diagnostic and prognostic applications along the melanoma continuum. ...
Tags: HTG Molecular, JWCI, melanoma signature, signature assays
Lab21 has entered into a collaboration agreement to develop polymerase chain reaction-based assays on BD Diagnostics' automated BD MAX molecular system for a series of oncology markers. The two assays, which will be initially developed, ...
Tags: Lab21, collaboration agreement, BD Diagnostics, reaction-based assays
Iverson Genetic Diagnostics has signed an agreement with Johns Hopkins University School of Medicine to license a molecular diagnostics test which determines cardiovascular risk in men and women and infertility risk in women. Under the ...
Tags: Iverson, agreement, molecular diagnostics test, heart disease
Seegene has developed a new real-time multiplex quantification molecular diagnostic testing technology. The new technology is designed for the simultaneous detection and quantification of up to 20 analytes on an existing 4-channel ...
Roche has gained FDA approval for the new HIV viral load test, the COBAS TaqMan HIV-1 Test, v2.0, and will launch the product in the US, later in 2012. The COBAS TaqMan HIV-1 Test, v2.0, targets two highly conserved regions of the HIV-1 ...
Enzo Biochem, a molecular diagnostics company, has introduced the ColonSentry blood-based risk stratification test to assess a patient's risk of having colorectal cancer. ColonSentry requires a small blood sample and utilizes RNA to ...
Tags: Enzo Biochem, ColonSentry blood-based risk stratification test
Iverson Genetic Diagnostics has entered into a licensing agreement with Johns Hopkins University School of Medicine for a molecular diagnostics test, designed to help physicians to assess cardiovascular risk in men and women, and ...
Tags: Iverson Genetic Diagnostics, SR-BI, molecular diagnostics test
Abbott will expand the current CE-IVD product labeling for its Vysis ALK Break Apart FISH Probe Kit to allow the test to be marketed in the European Union as a companion diagnostic. The test uses Abbott's proprietary fluorescence in situ ...
Tags: Abbott, anaplastic lymphoma kinase, ALK, FISH technology
EnviroLogix has signed a collaborative agreement with Douglas Scientific to develop and optimize solutions for nucleic acid analysis solutions. The companies will leverage and build upon EnviroLogix isothermal DNAblev2.0 chemistry and ...
Tags: EnviroLogix, nucleic acid analysis solutions, new DNAble assay solution
MDxHealth and PLUS Diagnostics have reached an agreement to co-promote MDxHealth's ConfirmMDx for prostate cancer in the US. ConfirmMDx is a laboratory-developed test (LDT), which assists urologists with identifying men who may safely ...
Tags: prostate cancer assay, cancer assessment, clinical research