IVD

Co-Diagnostics Grabs CE Mark for Coronavirus IVD

The Salt Lake City, UT-based company’s Logix Smart Coronavirus COVID-19 Test comes at a time when there 80,370 cases worldwide. About 2,707 have died from the disease.

Grail Hits Another Milestone by Initiating PATHFINDER Study

PATHFINDER is a multi-center study and Grail will share the results with healthcare providers and communicate the results to participants to help guide appropriate diagnostic workups for more than 50 cancer types.

8 Ways the Medtech Industry is Responding to the Coronavirus

The 2019 n-cov has infected more than 60, 414 people worldwide and has a death toll of 1,370. Here are eight ways the industry is tackling the coronavirus.

FDA Gives EUA to CDC Coronavirus Detection Test

The move comes only a few days after FDA laid out a plan that would see it working with the industry and international partners to expedite the development and availability of medical products needed to diagnose, treat, mitigate, and prevent coronavirus outbreaks.

Partnership Seeks to Address Gaps in Diagnosing Sepsis

QuantuMDx Group Limited and Ontera Inc. are working together on a system to rapidly identify blood stream infection and drug resistance.

New Optical Biosensor Can Cut into Sepsis Diagnosis Time

A study surrounding the device was recently published in Small.

Quest Discovers Genetic Blueprint with Latest Deal

The Secaucus, NJ-based company will acquire Blueprint Genetics for an undisclosed sum.

Blood Test Gives Greater Insight on Heart Attack Risk After Surgery

A new study conducted by researchers from Hamilton Health Sciences shows a blood test done before surgery can predict who will experience adverse cardiovascular outcomes after most types of procedures.

FTC Brings Illumina and PacBio Merger to a Screeching Halt

The Federal Trade Commission said it is challenging the $1.2 billion-merger between Illumina and PacificBio because it could create a monopoly in the U.S. market for next-generation DNA sequencing.

FoundationOne CDx by Foundation Medicine Inc.

Foundation Medicine Expands Companion Diagnostics Offerings

Identifying specific mutations can help match patients to targeted therapies.

C2N Diagnostics Brings Home Positive Results for Alzheimer’s Test

The St. Louis-based company unveiled the results at the 12th Annual Clinical Trials in Alzheimer’s Disease conference.

PGDx Cancer Assay Wins IDE to Be Used in Merck Trial

The Baltimore-based company’s elio assay will be used to analyze genomic markets to direct patient enrollment and stratification.

Say What … Using AI to Discover Signs of Heart Disease on Lung Cancer Screens?

The research on the artificial intelligence solution was presented at the annual meeting of the Radiological Society of North America.

Tiny Circuits Made of DNA Used for Cancer Detection

The detection tool was developed by Duke University Researchers and could help ensure that cancer screens and therapies zero in on the right culprits.

Supporting the Digital Movement of Diagnostics Data

Beckman Coulter employs informatics to automate sample processing and the delivery of testing results.

Thermo Fisher Rumored to Be Interested in Acquiring Qiagen

Waltham, MA-based Thermo Fisher Scientific could be acquiring Qiagen, according to a report from Bloomberg citing people with knowledge of the matter.

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