Exciting news flash from the world of (digital) diagnostics relevant collaborations, product launches and approvals.
For September 2022, the following collaborations that caught our attention from the diagnostics perspective. Check them out:
The companies announced a collaboration to develop FoundationOne®CDx as a companion diagnostic for Day One’s lead investigational therapy, tovorafenib(DAY101).
2. Novo Nordisk, Microsoft Collaborate on Drug Discovery Using AI
The multi-year collaboration started with two use cases, including a large literature analysis and atherosclerosis risk prediction.
bioMérieux will launch a digital solution for diagnostics leveraging the compliant BrightInsight® Platform and BrightInsight Disease Management Solution; technology which can be configured to meet the highest regulated digital health Software as a Medical Device (SaMD) classifications.
4. UgenTec Taps Thermo Fisher to Commercialize CE-Marked FastFinder Plug-ins for PCR Assays
The 2 companies collabare to jointly commercialize several new CE-marked respiratory assay plug-ins for UngenTec's FastFinder analysis software. The collaboration will allow FastFinder to analyze and interpret results from TF's TaqPath kits.
5. Qiagen to Develop Companion Dx for New Parkinson's Drug
Qiagen and Neuron23 are working together to develop a companion diagnostic for Neuron23's LRRK2 inhibitor for Parkinson's disease.
Combining the power of spatial biology and AI, Propath and Nucleai push the boundaries of pathology tissue analytics to develop a novel, high multiplexed immunofluorescence (IF) panel and associated AI-powered algorithm for biomarker discovery and development.
7. SkylineDx announces commercial launch Merlin™ Assay as CE-IVD kit in Europe
The test provides a more personalized insight on the metastatic propensity of the skin cancer tumors, identifying patients with a low-risk tumor that could avoid the highly invasive sentinel lymph node biopsy (SLNB) surgery. The CE-IVD device is based on a well-established qPCR method that can easily run in molecular diagnostic laboratories.
This additional approval will allow more patients with locally advanced and metastatic non-small cell lung cancer broader access to the immunotherapy Libtayo.
9. Insulet Announces CE Mark Approval for Omnipod® 5 Automated Insulin Delivery System
Omnipod 5 is the first CE marked tubeless hybrid closed loop system (also known as automated insulin delivery) that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System to automatically adjust insulin and help protect against high and low glucose levels 1.
10. Viz.ai receives FDA clearance for pulmonary embolism-related algorithm
The new tool measures the diameter of the ventricles of the heart to provide the ratio of the maximum right ventricle diameter compared with the left ventricle. That can help indicate pulmonary embolism severity.
11. Siemens Healthineers Gains CE Marks for Seasonal Viral Disease Assays
Siemens Healthineers gained CE marking for a pair of combination assays for differentiating infections with SARS-CoV-2, influenza, and, in one of the tests, human respiratory syncytial virus.
The U.S. Food and Drug Administration (FDA) has granted approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in selection of patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC)
The Digital LightCycler System is a next-generation digital PCR system that helps clinical researchers better understand the nature of a patient’s cancer, genetic disease or infection. The new system has the potential to find and quantify ultra-rare, hard to detect mutations, leading to early diagnosis and treatment strategies.
14. QIAGEN Adds New Assays With CE-IVD Certification for NeuMoDx Integrated PCR System
New assays for Epstein-Barr virus (EBV) and human herpesvirus 6 (HHV-6) expand menu to now 16 available CE-IVD assays; Improved multiple-target assay for respiratory diseases in development; new dual-target SARS-CoV-2 design enables faster clinical decisions; Multiplex assay for detection of monkeypox planned to be made available in 2022
15. "World's first" non-invasive continuous glucose monitor to launch
GlucoRx and Cardiff University are set to bring out the world’s first non-invasive continuous glucose monitor (CGM) in what they say will herald a new era of needle-free monitoring for people with diabetes.