DxTerity Diagnostics announced Friday that it has entered a collaboration with online retail giant Amazon to distribute its at-home SARS-CoV-2 test, SafeWorkDx, to small businesses and customers at home in the U.S. The kits, available for sale as single tests and in 10-packs, gained FDA emergency use authorization in mid-October making it the first saliva-based at-home test kit approved for consumer use for both symptomatic and asymptomatic testing.
SafeWorkDx is a PCR-based test that detects the presence of viral genetic material but will not confirm immunity or detect antibodies. It’s use for asymptomatic people is important to help slow the spread of COVID-19 as many people can have the disease without showing any symptoms of the illness.
“We have demonstrated the reliability and quality of our COVID-19 testing solution with big business and now we want to expand access to customers at home and small businesses,” says Bob Terbrueggen, Ph.D., founder and CEO of DxTerity. “Amazon is the perfect partner for expanding access to millions of U.S. customers.”
According to DxTerity, the tests have been used at more than 130 U.S. corporations, including Fortune 500 companies, global pharmaceutical companies and entertainment groups.
The kits provide sample collection materials and a 48-hour stabilization kit for transport of samples, with instructions and shipping materials included. 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. There is a proven concordance between saliva and nasal swab sample inputs in terms of the accuracy of results. Validation studies showed high test sensitivity, with a low limit of detection of 50 virus copies per milliliter of sample.
Single test kits are available for $130 and 10-pack kits are available for $1250 on Amazon. Testing does not require supervised sample collection, and prescription authorization is included as part of test registration. The price includes pre-paid overnight return shipment and testing in DxTerity’s CLIA licensed and accredited laboratory.