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Home»Posts tagged with»molecular diagnostics

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

By Pallavi Madhiraju on March 26, 2026   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.

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

By Pallavi Madhiraju on March 11, 2026   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.

Insight Molecular Diagnostics builds regulatory case for GraftAssureDx kidney transplant test

By Soujanya Ravi on March 3, 2026   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.

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

By Pallavi Madhiraju on February 20, 2026   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.

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

By Pallavi Madhiraju on February 20, 2026   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.

Ambient-temperature RNA-ISH enters mainstream pathology as Molecular Instruments expands HCR Pro automation

By Pallavi Madhiraju on February 20, 2026   Pharma & Biotech  

Ambient-temperature RNA-ISH enters mainstream pathology as Molecular Instruments expands HCR Pro automation

Discover how Molecular Instruments’ ambient-temperature HCR Pro RNA-ISH on BOND-III could reshape clinical pathology automation and RNA diagnostics.

New England Biolabs strengthens liquid biopsy foundations with scalable cfDNA extraction launch

By Pallavi Madhiraju on February 14, 2026   Medical Devices & Diagnostics  

New England Biolabs strengthens liquid biopsy foundations with scalable cfDNA extraction launch

New England Biolabs launches an automation-ready cfDNA extraction kit. Find out what this changes for liquid biopsy workflows and diagnostics development.

Is Zepto Life Technology redefining fungal diagnostics with cell-free DNA technology?

By Pallavi Madhiraju on January 25, 2026   Medical Devices & Diagnostics  

Is Zepto Life Technology redefining fungal diagnostics with cell-free DNA technology?

Zepto Life Technology’s FungiFlex Mold Panel enables fast, noninvasive fungal diagnostics from blood. Find out what this could mean for patient care.

Can EpiSwitch PSE become more than a diagnostic tool in prostate disease management?

By Pallavi Madhiraju on January 25, 2026   Medical Devices & Diagnostics  

Can EpiSwitch PSE become more than a diagnostic tool in prostate disease management?

Doctors Studio’s ozone pilot shows promising 30-day shifts in prostate biomarkers tracked via EpiSwitch PSE. Could this reshape trial design? Find out.

Fulgent Genetics acquires Bako Diagnostics and StrataDx to expand AI pathology strategy

By Venkatesh B on January 1, 2026   Medical Devices & Diagnostics  

Fulgent Genetics acquires Bako Diagnostics and StrataDx to expand AI pathology strategy

Fulgent Genetics acquires Bako Diagnostics and StrataDx to scale AI pathology, expand national reach, and advance precision medicine strategy. Read full analysis.

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