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RSS FeedPosted 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 ...
Posted by Michael Wonder on 22 Feb 2020
FDA authorises marketing of the first genetic test to aid in the diagnosis of Fragile X syndrome
21 February 2020 - The U.S. Food and Drug Administration today authorised marketing of the first test to detect a genetic ...
Posted by Michael Wonder on 05 Feb 2020
FDA takes significant step in coronavirus response efforts, issues emergency use authorisation for the first 2019 novel coronavirus diagnostic
4 February 2020 - Critical milestone reached in response to this outbreak. ...
Posted by Michael Wonder on 28 Jan 2020
Jubilant Radiopharma Receives Approval from Health Canada for Drax Exametazime
27 January 2020 - Jubilant Radiopharma announced today that the company received approval from Health Canada for Drax Exametazine (Kit ...
Posted by Michael Wonder on 07 Jan 2020
RadioMedix and Curium announce FDA filing of copper Cu 64 dotatate injection new drug application
7 January 2020 - RadioMedix and its commercial partner Curium announced today that the new drug application for copper Cu 64 ...
Posted by Michael Wonder on 05 Dec 2019
FDA authorises marketing of diagnostic test that uses novel technology to detect MRSA bacteria
5 December 2019 - Today, the U.S. FDA authorised marketing of a new diagnostic test based on bacterial viability and novel ...
Posted by Michael Wonder on 06 Nov 2019
FDA authorises marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations
5 November 2019 - Today, the U.S. FDA authorised marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug ...