IVD

Siemens Developing New Diagnostic for COVID-19

The Erlangen, Germany-based company said its Fast Track Diagnostics (FTD) SARS-COV-2 Assay is already being shipped in Europe for research use only. Siemens Healthineers is looking at speaking with FDA to release the test under Emergency Use Authorization.

Liquid Biopsy Test Detects More than 50 Cancer Types

Grail had a huge win in the liquid biopsy space this week. The Menlo Park, CA-based company said results of its Circulating Cell-Free Genome Atlas study show its technology can detect 50 cancer types across all stages with a very low false-positive rate.

Healthcare Tech Company Nets $13M for Faster, More Accessible COVID-19 Test

A U.S. government contract is expected to accelerate the development, validation, and FDA clearance of Cue Health's portable, molecular diagnostic test to detect SARS-CoV-2, the virus that causes COVID-19, in less than 25 minutes using a simple nasal swab.

Abbott Brings Rapid Testing to the Front Lines

The new five-minute test is the second Abbott test to receive emergency use authorization by FDA for COVID-19 detection. Combined, Abbott expects to produce about 5 million tests a month.

Quarantined Physician Waiting on COVID-19 Test Results for Nearly 2 Weeks

Dr. Nefertiti Brown, who is an attending physician in California, was tested for COVID-19 on March 18th after displaying symptoms of the virus.

A Comprehensive Guide to COVID-19 EUA Submissions

Step-by-step recommendations from FDA on how to seek emergency use authorization (EUA) for COVID-19 tests, ventilators, and personal protective equipment, plus answers to frequently asked questions.

Supplier Stories for the Week of March 22

Here’s what was new in the world of medical device suppliers during the week of March 22, with many suppliers responding to needs in light of the COVID-19 pandemic.

Thermo Fisher Granted CE Mark for COVID-19 Test

The CE mark comes as the virus continues to rage through Europe. Italy has been decimated by COVID-19, with a death toll of about 7,503 people. However, current reports show the number of new cases in Europe is declining for the fourth day in a row.

Astrotech Developing New Test for COVID-19

The Austin, TX-based company said it is working on a mass spectrometry technology that can detect coronavirus and other lung diseases from the metabolites found in a person’s breath.

How CDRH Is Responding to COVID-19

FDA issued a letter to the medical device industry regarding steps the Center for Devices and Radiological Health has taken to prioritize work that advances the United States response during the coronavirus public health emergency.

Test Shows How Lung Cancer Patients Respond to Therapy

Irvine, CA-based Oncocyte inherited the DetermaIO test when it acquired Insight Genetics earlier this year. The company said it has completed Clinical Laboratory Improvements Amendments (CLIA) validation for the test.

Abbott Brings Home EUA for COVID-19 Test

The Abbott Park, IL-based company said it would deploy about 150,000 laboratory tests immediately and wanted to ramp up production to one million tests per week by the end of the month.

BD Ramps Up Production, Collaborates on New Diagnostic in Response to COVID-19

In addition to increasing production of its collection devices, BD worked with BioGX Inc. to request an FDA Emergency Use Authorization for a new COVID-19 diagnostic.

New Tests Enter the Scene as COVID-19 Rages On

Thermo Fisher Scientific is the latest company to be granted Emergency Use Authorization for a diagnostic to detect the coronavirus (COVID-19). Mayo Clinic also announced it has a test that been fully validated and submitted to FDA for review and EUA. The testing developments come after the Trump Administration announced over the weekend that there would be new strategies to limit the spread of the virus.