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Looking Beyond Pandemic, Roche Eyes Growing Opportunities for Dx Testing
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Roche Diagnostics CEO Thomas Schinecker said the infrastructure put in place due to the pandemic will allow for more diagnostic testing globally.

Roche Cobas HIV, Hepatitis C Tests Nab WHO Prequalification

Prequalification from the World Health Organization indicates that products meet high quality standards and are safe for their intended use.

Qiagen Moves Ahead After Thwarted Thermo Fisher Buyout With NeuMoDx as Key Growth Driver
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Qiagen has benefited from unexpected tailwinds due to COVID-19 testing and envisions post-pandemic growth with recently acquired NeuMoDx as a key contributor.

NeuMoDx Molecular Nabs CE Mark for HIV Viral Load Assay

The PCR test detects HIV-1 RNA on the NeuMoDx 96/288 Molecular Systems and joins the company's other bloodborne viral tests for hepatitis B and C.

Genedrive Hepatitis C Test Garners WHO Prequalification, Firm Plans £8M Raise

The test will be included in the World Health Organizations list of prequalified in vitro diagnostics and UN agencies will be able to procure it.

Nov 8, 2019

Bioneer Gets CE Mark for HCV Assay

Sep 24, 2019

Enzo Clinical Labs Gets NY State Approval for HBV Assay

Mar 19, 2019

Abbott Receives CE Mark for Alinity Molecular Diagnostics System, Assays

Mar 13, 2019

Genetron Health Adds Prospective Data on Early Detection of Viral Liver Cancer in Blood
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Dec 20, 2018

Cepheid HBV Viral Load Test Gets CE-IVD Clearance

Dec 18, 2018

Systaaq HBV Assay Receives CE Mark

Sep 25, 2018

Qiagen, NeuMoDx Aim to Quickly Build Out Test Menu for High-Volume MDx Systems
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Aug 9, 2018

Pathogen Response-Related Variants Tapped for Broader Disease Insights

Jul 30, 2018

FIND Awards Grants for Development of HCV Dx Tests

Jun 27, 2018

FDA Approves LabCorp Multiplex PCR Assay for HCV, HIV, HBV

May 10, 2018

Studies of Ancient Hepatitis B Reveal Previously Unknown Lineages in Europe

Mar 27, 2018

Genedrive, Arkray Healthcare Sign Distribution Agreement for India

Jan 25, 2018

FDA Grants Approval for Hologic Hepatitis B Viral Load Assay

Jan 4, 2018

Researchers Reconstruct Hepatitis B Virus Genome from 16th Century Mummy

Oct 23, 2017

Enzo Biochem Lands NYS Approval for Bacterial Vaginosis Test

Sep 5, 2017

Co-Diagnostics to Sell up to 36K Tests to Medcis Pathlabs India

Apr 5, 2017

Vela Diagnostics Quantitative Hepatitis B Test Gets CE-IVD Mark

Dec 14, 2016

Hologic to Divest Stake in Blood Screening Business to Grifols for $1.85B

Oct 21, 2016

Roche Receives FDA Approval for Cobas MPX Test

Oct 20, 2016

Roche Diagnostics Revenue Grows 7 Percent in First Nine Months of 2016

Breaking News
The Scan

Another Resignation

According to the Wall Street Journal, a third advisory panel member has resigned following the US Food and Drug Administration's approval of an Alzheimer's disease drug.

Novavax Finds Its Vaccine Effective

Reuters reports Novavax's SARS-CoV-2 vaccine is more than 90 percent effective in preventing COVID-19.

Can't Be Used

The US Food and Drug Administration says millions of vaccine doses made at an embattled manufacturing facility cannot be used, the New York Times reports.

PLOS Papers on Frozen Shoulder GWAS, Epstein-Barr Effects on Immune Cell Epigenetics, More

In PLOS this week: genome-wide association study of frozen shoulder, epigenetic patterns of Epstein-Barr-infected B lymphocyte cells, and more.