Genomics company DxTerity Diagnostics reported on Monday the receipt of US FDA Emergency Use Authorization (EUA 202120) for its updated SARS-CoV-2 RT-PCR test, SafeWorkDx, for the home as well as in the workplace to help prevent the spread of COVID-19.
The company revealed the SARS-CoV-2 test has been authorized for testing specimens collected from individuals suspected of COVID-19 by their healthcare provider (HCP) and from any individual, including from individuals without symptoms or other reasons to suspect COVID-19. The simple and streamlined testing process provides sample collection materials and a 48-hour stabilization kit for transport of samples.
According to the company, the kit is equipped with a SDNA-1000 Saliva Collection Device and provides secure barcoded tracking of specimen to ensure the samples can be de-identified and accurately traced for security and privacy purposes.
In conjunction, the company said it will be unrolling additional ordering capabilities in the coming weeks to meet the need for increased testing during the holiday season, providing peace of mind as people return to work.
Advita Ortho updates Chime clinical exchange application
Philips launches InkSpace Imaging Snuggle coil for 3.0T MRI systems
Realheart secures European patent for artificial heart technology
Median Technologies secures FDA clearance for AI lung cancer screening software
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval
Apiject to open new generic injectable drug manufacturing facility in Apex, NC
Zylox-Tonbridge agrees staged acquisition of Germany's Optimed
Kestra partners with Biobeat to add cuffless blood pressure monitoring to wearable defibrillator
Boston Scientific to acquire Valencia Technologies to expand overactive bladder portfolio