C. auris Diagnostic Submitted for FDA Breakthrough Device Designation
T2 Biosystems Inc. has submitted an application with the FDA for Breakthrough Device Designation for the company’s Candida auris test.
Category: Molecular Diagnostics
Molecular Diagnostics
Latest
Molecular Diagnostics
Latest
High-Efficiency Assay Promises Rapid Validation of ECHS1 Variants
A team of researchers in Tokyo, Japan, has developed a rapid, efficient assay system for validating ECHS1 variants.
Molecular Diagnostics
Latest
Molecular Autopsy Helps Explain Death of Child with COVID-19
An advanced DNA sequencing technique, or molecular autopsy, was able to determine why a young child died after a relatively mild infection, when a traditional autopsy could not.
Laboratory-Developed Tests: A Best Practices Primer
Most current molecular tests have been developed as laboratory-developed tests, outside the strict regulatory framework of the FDA.
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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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Centogene Launches Whole Genome Sequencing Solution for Rare Disease Diagnosis
Centogene launched an enhanced next-generation sequencing (NGS)-based assay, for rare and neurodegenerative diseases.
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Transfer RNA Biomarkers for Cancer Diagnosis Enabled by New Method
A new method of measuring tRNA in blood samples offers a simple and highly-precise alternative to invasive diagnostic and prognostic methods.
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PCR Biosystems Launches New Proofreading Polymerase Mix for NGS Prep Workflows
PCR Biosystems launched a new proofreading polymerase mix for NGS library preparation workflows: the VeriFi Library Amplification Mix.
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Genome-Wide CRISPR Screens Identify PARP Inhibitor Response in Prostate Cancer
A new study informed use of PARP inhibitors beyond BRCA1/2-deficient tumors and reevaluated biomarkers for PARP inhibition in prostate cancer.
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Bio-Rad Launches PTC Tempo 96 and PTC Tempo Deepwell Thermal Cyclers
Bio-Rad Laboratories launched two new thermal cyclers, designed to optimize PCR applications such as sequencing, cloning, and genotyping.
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Seegene to share Syndromic PCR Tech for Pandemic Prevention
Seegene declared the commencement of sharing its syndromic PCR technologies all over the world in an effort to prevent future pandemics.
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EIT Health Helps Streamline Launch of Diagnostic Test for Bipolar Disorder
EIT Health’s innovation project, EDIT-B, has developed a blood diagnostic test designed to differentiate bipolar disorder from depression.
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New Genome Sequence Method Seeks to Identify Harmful Mutations
Researchers successfully sequenced four people’s genomes and tracked the mutations in each of them, along with their genetic consequences.
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Acutis Diagnostics Leverages Sophia Genetics Tech to Create New NGS Test
To create the new assay, Acutis Diagnostics will pair SOPHiA DDM for Hereditary Cancers Solution with their laboratory analysis technologies.
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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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Why Multiplex Testing Will Become the Diagnostic Standard of Care
Though not a new diagnostic technique, multiplex testing is poised to become the standard of diagnostic care in the post-pandemic world.
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