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CE mark: Page 3
Indica gets CE-IVD Mark for prostate cancer screening tool
The algorithm helps pathologists identify and grade prostate cancer from core needle biopsy samples. It was developed by researchers at the University of Cologne in Germany and was trained with more than 870,000 digital scans of prostate cancer subtypes as well as healthy tissue.
May 22, 2022
LumiraDx COVID antigen test receives CE Mark
The company said the test allows users to complete up to 80 tests per eight-hour day on a single LumiraDx instrument and matches the LumiraDx SARS-CoV-2 Ag 12-minute test in terms of performance.
May 19, 2022
FDA clears Hologic's assay for human cytomegalovirus
It is Hologic's first test to be available in the U.S. for identifying post-transplant pathogens using the company's automated Panther system. Aptima CMV Quant also has the CE Mark for diagnostic use and viral load testing in Europe, Hologic said.
May 11, 2022
Agilent secures CE-IVD Mark for cervical cancer test
PD-L1 is an antibody expressed by cervical cancer tumors and is a key biomarker for predicting response to anti-PD-L1 therapies like Keytruda, according to Agilent. The company's PD-L1 IHC 22C3 pharmDx companion diagnostic identifies cervical cancer patients with a PD-L1 combined positive score of one or more, which indicates that they could benefit from treatment with Keytruda, the company said.
May 10, 2022
Innova partners with Attomarker on COVID immunity test
Through the partnership, Innova has made a minority investment in Attomarker and will become an official distributor of the latter's products.
May 5, 2022
SeekIn receives CE Mark for karyotyping kit
Designed to show copy number alteration patterns in leukemia patients based on shallow whole-genome sequencing, the test can help hematologists make diagnoses and prognostic decisions based on European Leukemia Net, Revised International Prognostic Scoring System, or Revised International Staging System guidelines, according to the vendor.
April 6, 2022
Genetic causes identified for three rare diseases
Researchers in study validate test to identify newborns with homocystinuria, a rare inherited disease
SARS-CoV-2 infection weakens immune-cell response to vaccination, study suggests
Duke University researchers discover biomarkers may identify early pancreatic cancer risk
Werfen completes $2B acquisition of Immucor, expands presence in specialized diagnostics
Chembio CEO urges stockholders to tender remaining shares as deadline is extended for acquisition
C2i Genomics launches MRD test in Europe
The test is the first software-as-a-medical-device MRD test and will be available in countries accepting the CE Mark, according to the company. Recently, it received CE-IVD marking in the European Union, U.K., and Switzerland.
April 5, 2022
Optellum's Virtual Nodule Clinic receives CE Mark
Virtual Nodule Clinic is an AI-powered clinical decision support software tool designed to help clinicians identify and track at-risk patients who present suspicious lung nodules that may or may not be cancerous.
March 30, 2022
Thermo Fisher launches new NGS platform
Designed for use in clinical laboratories, the system enables users to perform both diagnostic testing and clinical research on a single instrument, according to the vendor. Results are delivered in as little as one day, Thermo Fisher Scientific said. The system has received the CE-IVD mark.
March 29, 2022
Sense wins CE Mark for Veros COVID-19 test
Designed to provide results in 15 minutes at a performance comparable to polymerase chain reaction diagnostic technology, Veros COVID-19 is suitable for use in environments such as hospital emergency departments, pharmacies, care homes, and urgent care, according to Sense. In a multicenter trial, the IVD test yielded an accuracy rate of 97.9%, Sense said.
March 7, 2022
Luminex secures CE Mark for NxTag pathogen panel
NxTag GPP is designed to detect nucleic acids from 16 clinically relevant bacterial, viral, and parasitic pathogens, according to Luminex. The test provides same-day results and can run as many as 96 samples at a time, the company said. What's more, the test's targets can also be customized by users.
March 7, 2022
Diadem wins CE-IVD Mark for Alzheimer's prognostic blood test
The prognostic blood test can predict likely progression to Alzheimer's disease up to six years in advance of symptoms, according to the company. AlzoSure previously received breakthrough device designation by the U.S. Food and Drug Administration (FDA) in January.
February 28, 2022
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