FDA Grants Breakthrough Device Designation for Whole Genome and Exome Tests
The designation accelerates regulatory review for GeneDx's ExomeDx and GenomeDx testing platforms designed to diagnose rare diseases.
Category: Molecular Diagnostic Analyzers
Molecular Diagnostic Analyzers
Latest
Molecular Diagnostic Analyzers
Latest
Investigational Blood Test Detects ALS Up to 10 Years Before Symptoms Appear
Johns Hopkins-led study identifies protein signature with 98% accuracy in distinguishing ALS patients from healthy individuals and those with other neurological diseases.
Molecular Diagnostic Analyzers
Latest
MDSAP Certification Secured for Sub 10-minute Fast PCR System
AMDI has completed a successful clinical study of its Fast PCR-based Mini Respiratory Panel and earned MDSAP certification.
Post-Viral Syndromes and the Utility of T-cell Diagnostics
There is a potential to use T-cell diagnostics to diagnose underlying post-viral syndromes by measuring the bodies adaptive immune resistance.
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FDA Clears Cardiac Troponin I Test for Myocardial Infarction Diagnosis
The new high-sensitivity troponin assay is designed for use on the the PATHFAST Biomarker Analyzer from Polymedco.
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QIAGEN Upgrades its Syndromic Testing Analyzer
The QIAstat-Dx Analyzer 2.0 enables mobile access to test results, streamlining diagnostic processes and enhancing patient care.
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BIOTYPE Upgrades Benchtop Diagnostic Platform for Multi-Gene Testing
BIOTYPE presented a major upgrade to its benchtop diagnostic platform for the fully integrated analysis of molecular biomarker signatures.
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Roche Expands HPV Testing for Cobas 5800 Molecular System
Roche announced the U.S. FDA approved the cobas HPV test for use on its next-generation cobas 5800 molecular instrument.
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AlloSure Lung dd-cfDNA Testing Service Receives Medicare Coverage
CareDx, Inc. has announced that its AlloSure Lung donor-derived cell-free DNA molecular testing service has received Medicare coverage.
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Molecular Imaging & Histology Combine for Better Cancer Diagnosis
Orion combines histologic with molecular imaging information and offers deeper insight into a tumor’s type.Â
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New Centre for Phage Research features Actiphage
The first Centre for Phage Research launched on May 16 and featured in the Innovate UK KTN’s UK Phage Innovation Showcase will be Actiphage.
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De Novo Submission Made for Full Clearance of its Cue RSV Molecular Test
Cue Health announced that it has made a De Novo submission to the FDA for full clearance of the Cue RSV Molecular Test.
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PathogenDx Expands Reach of Multiplexed Molecular Testing Tech
PathogenDx expanded the reach of its patented multiplexed molecular testing technology, Dynamic Dimensional Detection (D3 Array).
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Planned Parenthood Expands Access to STI Testing
Planned Parenthood Mar Monte (PPMM) has teamed with BD to provide STI testing for the most common infections to underserved populations.
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The Opportunity to Upgrade Pharyngitis Testing
Pharyngitis testing and diagnosis can be improved by utilizing existing molecular testing capacity increased due to COVID.
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As CML Outcomes Improve, Demand Rises for BCR::ABL1 Testing
Patients with chronic myeloid leukemia need regular BCR::ABL1 testing for the rest of their lives, which can translate into more lab work.
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New Method for the Detection of RNA Viruses
Experts have developed a new methodology to detect RNA viruses based on the triplex-forming probe technology.
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Using Electrochemical Cell-Free Biosensors for Antibody Detection
A new method of rapid, yet quantitative and specific point-of-care detection of antibodies uses an electrochemical cell-free biosensor.
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