In key CE-IVD mark news announced recently, most of the products have focused on cancer-related applications. Of four announcements made just last week, two related to a companion diagnostic that helps select patients for certain cancer treatments, while another product helps detect cancer metastasis. And, the fourth product can also be used in cancer-related applications, among others. Here’s a quick summary of the main announcements:
March 29: Thermo Fisher Scientific announced the launch of its CE-IVD marked Ion Torrent Genexus Dx Integrated Sequencer. According to the company, this automated next generation sequencing platform, which is designed for use in clinical labs, can provide results as quickly as within a single day. The system also allows laboratorians to do both clinical research and diagnostic testing on the same instrument.1
April 5: Agilent Technologies announced that it has received CE-IVD marking in the European Union for expanded use of one of its companion diagnostics. The PD-L1 IHC 28-8 pharmDx immunohistochemical assay can now be used to identify certain patients diagnosed with muscle-invasive urothelial carcinoma for adjuvant treatment with Bristol Myers Squibb’s immunotherapeutic OPDIVO® (nivolumab). On the same day, the company announced the assay also received CE-IVD marking to expand its use to the selection of patients with esophageal squamous cell carcinoma for treatment with OPDIVO® combined with either YERVOY® (ipilimumab) or fluoropyrimidine and platinum-based chemotherapy.2,3
April 6: Computational pathology company Paige announced it has received both CE-IVD and UKCA marks for its for Paige Breast Lymph Node AI medical device software. Used in combination with a pathologist’s own interpretive review, the software aids in detecting if breast cancer has metastasized to a patient’s lymph nodes.4
Look for more insight on recent CE-IVD marking news in our upcoming monthly briefings.
References:
- https://www.businesswire.com/news/home/20220329005106/en/Thermo-Fisher-Scientific-Launches-CE-IVD-Marked-Next-Generation-Sequencing-Instrument-for-Use-in-Clinical-Labs
- https://www.businesswire.com/news/home/20220405005748/en/Agilent-Companion-Diagnostic-Expands-CE-IVD-Mark-for-PD-L1-IHC-28-8-pharmDx-to-Include-Muscle-Invasive-Urothelial-Carcinoma-MIUC
- https://www.businesswire.com/news/home/20220405005750/en/Agilent-Companion-Diagnostic-Expands-CE-IVD-Mark-for-PD-L1-IHC-28-8-pharmDx-to-Include-Esophageal-Squamous-Cell-Carcinoma
- https://www.businesswire.com/news/home/20220406005362/en/Paige-Earns-CE-IVD-and-UKCA-Marks-for-Clinical-AI-Application-to-Detect-Breast-Cancer-Metastases-in-Lymph-Nodes