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Roche launches next-gen COVID-19 rapid tests for professional use and self-testing
Roche is building on a broad portfolio of COVID-19 rapid tests with three new test configurations that feature an improved capture antibody and the addition of new digital data sharing capabilities.
October 12, 2022
Virax Biolabs nabs CE Mark for monkeypox rapid antigen test
The test kits are used in point-of-care settings, providing results in 15 minutes to help healthcare professionals identify a monkeypox infection in people suspected of carrying the virus, Virax Biolabs said.
September 19, 2022
Qiagen developing, releasing assays for NeuMoDx system
The assays, which permit the identification and quantification of the Epstein-Barr virus (EBV) and human herpesvirus 6 (HHV-6), have received CE-IVD certification for use in countries in the European Union and other countries that accept the CE Mark, Qiagen said.
September 15, 2022
MagBio Genomics secures 510(k), CE Mark approval
A guanidine-free molecular transport medium, the MagXtract Collection Tube eliminates the risk of accidentally creating cyanide gas during cleaning, directly lyses cells during transport, inactivates pathogens, and maintains ambient temperature stability of RNA samples for up to eight days, thus eliminating the need for cold storage and shipping, the firm said.
September 11, 2022
CorDx obtains CE Mark for monkeypox tests
The three tests are the following:
August 24, 2022
Nanostics secures CE Mark for ClarityDx Prostate
ClarityDx Prostate, which detects and measures extracellular vesicles, is based on a machine-learning algorithm that combines data from biological and clinical biomarkers to generate a risk score for prostate cancer that has a Gleason grade group 2 or higher on prostate biopsy.
August 22, 2022
Dr. Fauci invokes Yogi Berra to describe emerging infectious disease challenge
C2N Diagnostics launching next-generation blood test for Alzheimer's disease detection
Thermo Fisher Scientific introduces digital PCR liquid-biopsy assays for academic, clinical research
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
Aspira announces commercial launch of blood-based ovarian cancer risk assay
Sherlock Biosciences secures funding to further develop CRISPR testing platform
GenScript launches monkeypox PCR test
The kit, which was developed in partnership with Anbio Biotechnology, can be ordered now by diagnostic labs and medical device distributors to be used in research to detect the monkeypox virus.
August 17, 2022
Predicine brings cell-free DNA assay to Europe
The targeted next-generation sequencing assay, which has received the CE Mark, is designed to detect single nucleotide variants (SNVs), insertions and deletions (indels), DNA rearrangements (fusions), and copy number variations (CNVs) in patients diagnosed with cancer, according to the vendor.
August 9, 2022
Imspex lands CE Mark for COVID-19 breath test
A breath analyzer based on a combination of gas chromatography and ion mobility spectrometry technologies, BreathSpec is designed for use in a point-of-care setting by clinicians and nontechnical users in diagnosing respiratory tract infections, with specific utility for COVID-19, according to the Wales-based vendor.
August 8, 2022
Seegene outlines expansion strategies at AACC 2022
At AACC, the company displayed its fully automated Starlet-Aios (all-in-one system) for which it has obtained the CE-IVDR Mark.
July 28, 2022
BD nabs CE Mark for respiratory viral panel
The panel, a molecular diagnostic combination test for SARS-CoV-2, influenza A + B, and respiratory syncytial virus (RSV), uses a nasal swab or nasopharyngeal swab sample.
June 30, 2022
Pictor receives CE Mark for COVID-19 test
The PictArray SARS-CoV-2 assay is the first test of its kind, according to the company. The test enables personalized COVID-19 assessments by detecting if a patient has antibodies from a previous infection of SARS-CoV-2 (from spike protein and nucleocapsid protein antibodies) or from vaccination alone (SP antibodies only).
June 22, 2022
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