Blog
RSS FeedPosted by Michael Wonder on 17 Sep 2020
Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer
16 September 2020 - Next generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly ...
Posted by Michael Wonder on 15 Sep 2020
FDA publishes comparative performance data for COVID-19 molecular diagnostic tests
15 September 2020 - Today, the U.S. FDA published comparative performance data for some authorised COVID-19 molecular diagnostic tests. ...
Posted by Michael Wonder on 09 Sep 2020
Clarity Pharmaceuticals announces the US FDA grants rare paediatric disease designation to 64 Cu sartate, a diagnostic for the clinical management of neuroblastoma
9 September 2020 - Clarity Pharmaceuticals is pleased to announce that the U.S. FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 08 Sep 2020
Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients
8 September 2020 - New breakthrough device test expands Roche molecular test menu for transplant patients, enabling simultaneous testing of BK ...
Posted by Michael Wonder on 08 Sep 2020
RadioMedix and Curium announce FDA approval of Detectnet (copper Cu 64 dotatate injection) in the U.S.
7 September 2020 - RadioMedix and its commercial partner Curium announced today that Detectnet (copper Cu 64 dotatate injection) was approved ...
Posted by Michael Wonder on 01 Sep 2020
Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
1 September 2020 - Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management ...
Posted by Michael Wonder on 31 Aug 2020
A quick virus test? Sure, if you can afford it.
31 August 2020 - Standard tests in New York City can take days or weeks. Wealthier people are turning to concierge ...
Posted by Michael Wonder on 27 Aug 2020
FDA approves Foundation Medicine's FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test with multiple companion diagnostic indications for patients with advanced cancer
26 August 2020 - FDA approval includes companion diagnostic claims for Rubraca (rucaparib), the first PARP inhibitor approved in a prostate ...
Posted by Michael Wonder on 31 Jul 2020
Medicare expands coverage for BRACAnalysis CDx in prostate cancer
31 July 2020 - Myriad Genetics announced today that Medicare has expanded coverage for BRACAnalysis CDx for men with prostate cancer ...
Posted by Michael Wonder on 29 Jul 2020
Alzheimer's: 'promising' blood test for early stage of disease
29 July 2020 - A blood test could spot Alzheimer's disease at the earliest stage and years before symptoms appear, ...
Posted by Michael Wonder on 29 Jul 2020
FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy
29 July 2020 - Developed with enhanced technology, this new assay provides high-quality staining with improved turnaround time. ...
Posted by Michael Wonder on 01 Jun 2020
Zionexa USA and PETNET Solutions announce FDA approval of Cerianna (Fluoroestradiol F 18)
27 May 2020 - Zionexa USA and PETNET Solutions have announced that the FDA has approved Cerianna (fluoroestradiol F 18) injection ...
Posted by Michael Wonder on 29 May 2020
FDA approves first drug to image tau pathology in patients being evaluated for Alzheimer’s disease
28 May 2020 - Today, the U.S. FDA approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help ...
Posted by Michael Wonder on 08 Apr 2020
Advanced Accelerator Applications announces Health Canada approval of Netspot diagnostic imaging agent kit to detect neuroendocrine tumours
7 April 2020 - Netspot is the first and only kit for the preparation of gallium (68 Ga) oxodotreotide injection for ...
Posted by Michael Wonder on 12 Mar 2020
RadioMedix and Curium Announce copper Cu 64 dotatate injection was granted priority review by the U.S. FDA
11 March 2020 - RadioMedix and its commercial partner Curium announced the U.S. FDA has granted copper Cu 64 dotatate injection ...