CMS Sets Preliminary Payment Rate for Optical Genome Mapping CPT Code
The new Category I code for constitutional genetic disorders receives crosswalk pricing of $1,263.53, higher than comparable microarray codes.
Category: Molecular Diagnostics
Molecular Diagnostics
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Molecular Diagnostics
Latest
FDA Clears Tumor Profiling Assay that Analyzes 425 Cancer-Related Genes
The NGS-based test joins CE-IVD and NMPA approvals for global market access.
Molecular Diagnostics
Latest
cDNA Synthesis and Amplification Kit for Enhanced Short-Read RNA Sequencing Launches
The kit aims to improve the detection of challenging transcripts, including rare isoforms and long noncoding RNAs.
Three Molecular Testing Companies Merge to Form OSPRI
Community Direct DX, Scienetix, and Advanta Genetics R&D combine with $30 million in funding to create a vertically integrated PCR testing platform.
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FDA Approves Companion Test to Identify Patients Eligible for New NSCLC Treatment
The test is approved to identify patients eligible for Hernexeos, an orally administered targeted treatment for HER2 (ERBB2)-mutant non-small cell lung cancer.
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NeoGenomics Launches Blood-Based Genomic Profiling Test
The liquid biopsy test uses circulating tumor DNA to support therapy selection, trial matching, and monitoring—even when tissue is limited.
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Implementing Long-Read Sequencing in Clinical Labs
As accessibility to long-read sequencing technologies like Oxford Nanopore and PacBio increases, clinical laboratories must assess their readiness for implementation.
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Signatera MRD Test Gets Breakthrough Device Designations
Natera has received two new FDA Breakthrough Device Designations for its personalized Signatera ctDNA test.
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NEBNext Low-bias Small RNA Library Prep Kit Launched by NEB
New England Biolabs has launched the NEBNext Low-bias Small RNA Library Prep Kit, a next-generation tool that minimizes sequencing bias.
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Genetic Test Predicts Childhood Obesity Risk
A new genetic test developed using data from over five million people can predict obesity risk in early childhood.
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Bridge Capture Matches ddPCR in Colorectal Cancer Pilot
Genomill’s Bridge Capture technology achieved gold-standard sensitivity in detecting mutations in metastatic colorectal cancer patients.
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RT-LAMP Assay Provides Affordable, Reliable Pathogen Detection
A collaborative study has developed a low-cost, open-source, lyophilized RT-LAMP assay for pathogen detection.
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Bio-Rad Expands ddPCR Offering Through Strategic Acquisition and Platform Rollout
Bio-Rad Laboratories has expanded its ddPCR product portfolio with four new platforms, including the QX Continuum and QX700 series.
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Oncomine Dx Express Test Receives FDA Approval as a Companion Diagnostic
The FDA has approved Thermo Fisher’s Oncomine Dx Express Test on the Genexus Dx Integrated Sequencer as a companion diagnostic for ZEGFROVY.
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CRISPR-Cas10 Integrated with Graphene Field-Effect Transistors Offer Innovative RNA Detection Approach
Researchers have developed a CRISPR-Cas10-integrated graphene biosensor for amplification-free, ultra-sensitive RNA and miRNA detection.
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SeqOnce Biosciences Adds RT-qPCR Measles Panel
SeqOnce has launched Measles Panel A, a new RT-qPCR assay designed to detect all known measles genotypes—including the D8 genotype.
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Seegene Launches STAgora for Infectious Disease Analytics
Seegene has launched STAgora, a next-gen infectious disease analytics platform providing real-time, AI-driven insights.
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PanTracer Tissue and PanTracer Tissue + HRD Are Now Available
NeoGenomics has launched PanTracer Tissue and PanTracer Tissue + HRD, advanced solid tumor profiling assays.
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