PerkinElmer Covid-19 Assay Gets FDA EUA for Asymptomatic Testing
The PerkinElmer New Coronavirus Nucleic Acid Detection Kit received EUA from the FDA to test individuals without symptoms or other reasons to suspect covid-19 infection.
Category: Molecular Diagnostics
Molecular Diagnostics
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Molecular Diagnostics
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Illumina, Harvard Pilgrim Expand Access to WGS for Genetic Disease Testing
The risk-sharing agreement will make whole-genome sequencing available to certain pediatric Harvard Pilgrim members, effective January 1, 2021.
Molecular Diagnostics
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Aperiomics Brings Pathogen Testing to Integrative Healthcare Field
With a single test of any biological sample, Aperiomics seeks to accurately identify all microbes present—including pathogens—whether bacteria, fungus, parasite, or virus.
Molecular Diagnostics in 2020
Surveys from the Association for Molecular Pathology reveal the impact of the covid-19 pandemic on clinical labs and help to chart the course for 2021.
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Aptima HIV-1 Quant Dx Assay Receives Additional FDA Approval for Use as an Aid in the Diagnosis of HIV Infection
Hologic’s Aptima HIV-1 Quant Dx assay is now the first dual-claim assay for both diagnosis and viral load monitoring in the United States.
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Increased Sensitivity for qPCR of Low Input and Degraded Samples
The Crescendo cDNA Synthesis for qPCR system can generate large quantities of cDNA from as little as 500 pg of total RNA.
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HHS Launches Pilot Program of Fast Molecular POC Test for Covid-19
Alaska, Florida, Louisiana, New Jersey, and Texas will receive the first shipments of the test used in the NBA bubble.
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FDA Approves Pan Tumor Liquid Biopsy Test to ID Patients for Treatment with Lynparza
FoundationOne Liquid CDx Identifies Patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer (mCRPC) who may be appropriate for treatment with Lynparza.
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P3 Reagent Kit Expands Potential of Illumina’s NextSeq 2000
The P3 flow cell offers 1.1 billion reads in a single sequencing run, almost three times more than previously available.
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Medicare Coverage of StrataNGS for Patients with Advanced Solid Tumors
A Medicare administrative contractor has established coverage of the StrataNGS test for patients with advanced stages (III or IV), recurrent, relapsed, refractory, and/or metastatic solid tumors.
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Simple, Cost-Effective Molecular Assay May Help Manage Drug-Resistant Gonorrhea
A multiplex assay based on high-resolution melting technology accurately identified antimicrobial resistant determinants in Neisseria gonorrhoeae.
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FDA Approves FoundationOne CDx as Companion Diagnostic to Detect NTRK Fusions Across All Solid Tumors
The tissue-based comprehensive genomic profiling test is currently approved as a companion diagnostic for more than 20 targeted therapies.
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Breakthrough Blood Test Developed for Brain Tumors
Research shows a noninvasive ddPCR test can help physicians diagnose and monitor the clinical progress of patients with gliomas.
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RUO Rapid Test for Respiratory Co-Infections and AR Pathogens
The test is designed to detect respiratory co-infections as well as antibiotic-resistant pathogens in patients with SARS-CoV-2.
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Extraction-Free Direct RT-PCR Test for Covid-19
BioGX’s high-throughput RT-PCR test for covid-19 has been submitted for FDA EUA.
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FDA EUA for Saline Oral Rinse Covid-19 RT-PCR Test
The OraRisk Covid-19 RT-PCR test received the first EUA for a simple saline 30 second swish-and-gargle collection.
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Oncotype Map Pan-Cancer Tissue Test to Guide Treatment for Advanced Cancer
Exact Sciences’ comprehensive genomic profiling panel aids therapy selection decisions for a breadth of solid tumor types.
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September 2019 Tech Guide: Molecular Diagnostics
The September 2019 Tech Guide features molecular diagnostic systems and panels from Abbott Molecular, Agena bioscience, BD, Bio-Rad Laboratories, Luminex, NewMoDx, Qiagen, and more.
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