Diagnostic Technology, Applications, and Disease Research News

CMS Meeting Suggests Growing Lab Interest in ADLT Status

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Though the designation has seen slow uptake thus far, three tests received ADLT status in May, bringing the total number of approved ADLTs to five.

HiberGene Outlines Plans for Low-Cost Point-of-Care Molecular Diagnostic System

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The Dublin, Ireland-based company plans to launch its new instrument by the end of 2021 and will pursue CLIA waiver in the US.

Q&A: ARUP's Jonathan Genzen on Legislative Proposals to Regulate Lab-Developed Tests

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The ARUP COO recently published a commentary providing the clinical lab perspective on recent congressional proposals around LDT regulation.

MSK Researchers Describe Clinical-Grade Deep Learning Approach to Assist Pathologists

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Johns Hopkins Team Develops Test to Guide Pancreatic Cyst Treatment

The researchers have developed CompCyst, which uses clinical features, imaging, and molecular data, to guide pancreatic cysts treatment approaches.

Startup Nephrosant Aims to Launch Noninvasive Kidney Transplantation Test by Early 2020

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The UCSF spinout aims to develop noninvasive tests to detect kidney injury for the transplantation field and to diagnose and monitor chronic disease.

Abbott Seeking Broader Adoption of Diabetes Testing With Point-of-Care Technology

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Abbott said that its Afinion HbA1c assay used to diagnose diabetes could eventually be made available in physicians' offices through a CLIA waiver.

Business & Policy

Bio-Techne, Uman Diagnostics Ink License, Supply Agreement for Neurofilament Light Assay

The firms said that Bio-Techne's Ella platform provides the sensitivity needed to provide analysis of the Nf-L biomarker for neurodegenerative diseases.

Ortho Clinical Diagnostics Receives CE Mark for Enhanced Cardiac Assay

Quest Diagnostics Q2 Revenues Grow 2 Percent

China's NMPA Extends Approval for Roche Cobas EGFR Mutation Test v2 to Plasma Samples

Diagnostics

Dutch Startup Cyclomics Developing Liquid Biopsy Assay Using Nanopore Sequencing

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Cyclomics, a 2018 spinout from University Medical Center Utrecht, is testing its assay for treatment response and recurrence monitoring in head and neck cancer.

Bio-Techne, Uman Diagnostics Ink License, Supply Agreement for Neurofilament Light Assay

Ortho Clinical Diagnostics Receives CE Mark for Enhanced Cardiac Assay

China's NMPA Extends Approval for Roche Cobas EGFR Mutation Test v2 to Plasma Samples

Medical Conditions

Dutch Startup Cyclomics Developing Liquid Biopsy Assay Using Nanopore Sequencing

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Cyclomics, a 2018 spinout from University Medical Center Utrecht, is testing its assay for treatment response and recurrence monitoring in head and neck cancer.

China's NMPA Extends Approval for Roche Cobas EGFR Mutation Test v2 to Plasma Samples

Curetis Submits Lower Respiratory Tract Infection Test for FDA Clearance

Roche Expands Global Access Program to Include Tuberculosis, Hepatitis, HPV Tests

Clinical Lab Management

Quest Diagnostics Q2 Revenues Grow 2 Percent

The lab beat the consensus Wall Street estimate on the top and bottom line, and maintained its revenue and adjusted EPS guidance for full-year 2019.

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