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Dec 03, 2019

Co-Diagnostics Joint Venture Gets Clearance in India for Five MDx Tests

The clearance covers tests made by the firm's joint venture for manufacturing, CoSara Diagnostics, in its facility in Ranoli, India.

Nov 20, 2019

Beckman Coulter, IncellDx Form Cancer Assay Promotion Agreement

The flow cytometry-based assays were developed by Menlo Park, California-based IncellDx to run on Beckman Coulter instrumentation.

Nov 12, 2019

Becton Dickinson Submits HPV Assay for Expanded US Premarket Approval

The assay, which received premarket approval last year, detects 14 high-risk HPV types and individually identifies and reports HPV genotypes 16, 18, and 45.

Oct 17, 2019

NeuMoDx, SelfScreen Collaborate to Obtain CE Marking for HPV Assay

The agreement enables NeuMoDx to bring sample-to-result HPV screening to customers in Europe, where its systems are distributed by Qiagen.

Oct 15, 2019

Enzo Biochem Fiscal Q4 Revenues Down 8 Percent

The company said that the decline in revenues reflected lower industry-wide reimbursement rates under PAMA.

Aug 30, 2019

Transcriptome-Based HPV Assay Shows Correlation With High-Grade Cytology

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The new test uses the number of sequencing reads at specific early and late HPV transcripts as a biomarker for high-grade cytology.

Aug 08, 2019

Atila BioSystems Targets Low-Resource Settings With Rapid, High-Throughput HPV Genotyping System

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The system has been evaluated by researchers studying cervical cancer prevention as well as other HPV-related cancers, with positive feedback so far.

Aug 07, 2019

Becton Dickinson Says Diagnostics Uptake Remains Strong, Chinese Market Flourishing

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In an earnings call, the firm said it sees growth continuing for the BD Max, BD Cor, and Phoenix systems, and in China in general.

Jul 29, 2019

Startup Credo Biomedical Launching Low-Cost Point-of-Care Influenza MDx

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The Singapore-based company will debut a system at AACC that performs real-time PCR flu A/B testing in less than 20 minutes for the cost of a lateral flow test. 

Jun 18, 2019

BD High-Throughput MDx System CE Marked

The high-throughput, scalable BD Cor system for infectious disease diagnostics is now available in Europe with the firm's BD Onclarity HPV assay. 

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The Scan

That Rude Reviewer

ScienceInsider reports that rude and unprofessional paper reviewers are common and can have harmful effects.

New FDA Commish Confirmed

The US Senate has confirmed Stephen Hahn as the next commissioner of the Food and Drug Administration, according to the New York Times.

DNA Screening for Apple Employees

CNBC reports Apple is partnering with Color Genomics to offer its employees free DNA screening for disease.

Science Studies Describe Role for Microbiome-Derived Immunity, Platform to Develop Flavivirus Vaccines

In Science this week: researchers use CRISPR tool to find gut microbiome molecules involved in immunity, and more.

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