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molecular diagnostics

Medical Devices & Diagnostics

One blood sample, 68,000 possible pathogens: Can Delve Bio speed up infection diagnosis?

Delve Bio has launched a plasma metagenomic sequencing service designed to identify DNA and RNA pathogens using a database covering more than 68,000 organisms. The test promises results the day after sample receipt, but plasma-specific diagnostic accuracy and clinical utility remain important questions.

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Medical Devices & Diagnostics

Cepheid’s Xpert panel could reshape Ebola outbreak diagnostics, but scale is the real test

Find out how Cepheid’s Xpert Hemorrhagic Fever panel could reshape Ebola Bundibugyo testing in Africa amid urgent diagnostic gaps.

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Medical Devices & Diagnostics

Why Zepto Life Technology’s FDA breakthrough status matters for infectious disease diagnostics

Zepto’s FungiFlex brings liquid biopsy to invasive mold infections. The FDA designation tests whether faster fungal diagnosis can change care.

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Medical Devices & Diagnostics

Could Co-Diagnostics’ Saudi manufacturing move strengthen its molecular diagnostics strategy?

Saudi localization gives Co-Diagnostics a new opening. The test is whether CoMira can turn a factory lease into diagnostics traction.

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Medical Devices & Diagnostics

Why Seek Labs’ amplification chemistry could matter beyond infectious disease testing

Molecular testing is powerful but lab-bound. Seek Labs’ patent raises a sharper question: can point-of-care diagnostics finally scale?

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Medical Devices & Diagnostics

What Invivoscribe’s IdentiClone Dx IGH approval reveals about the new economics of IVDR-ready hematology diagnostics

Invivoscribe’s IdentiClone Dx IGH won IVDR certification in the EU. Read what this means for clonality testing, lab adoption, and diagnostic competition.

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Medical Devices & Diagnostics

How QIAGEN’s QIAstat-Dx Rise GI panel clearance could reshape multiplex pathogen testing in clinical labs

QIAGEN wins FDA clearance for GI panels on QIAstat-Dx Rise. Discover what this means for syndromic testing platforms and molecular diagnostics adoption.

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Medical Devices & Diagnostics

Insight Molecular Diagnostics builds regulatory case for GraftAssureDx kidney transplant test

Insight Molecular Diagnostics advances GraftAssureDx toward FDA submission. Discover what this means for transplant rejection testing and dd-cfDNA diagnostics.

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Medical Devices & Diagnostics

What Belay Diagnostics’ Summit 2.0 results reveal about the future of CNS molecular diagnostics

Belay Diagnostics validates its Summit 2.0 CSF genomic assay, strengthening the clinical case for liquid biopsy in CNS cancers. Read the full analysis.

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Medical Devices & Diagnostics

Merlin CP-GEP becomes first NCCN-endorsed molecular test for early-stage melanoma risk assessment

NCCN guidelines now recommend Merlin CP-GEP for early-stage melanoma risk assessment. Discover what this changes for clinicians and diagnostics adoption.

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