NEW YORK — DxTerity Diagnostics said on Tuesday that it has received CE marking for its DxCollect at-home fingerstick blood collection device for RNA and DNA testing.
According to the company, the DxCollect MicroCollection Tube (MCD) contains a proprietary chemistry that stabilizes RNA and DNA at room temperature for up to two weeks, providing enough time for a sample to be mailed to a lab. It was launched in 2014 along with DxTerity's DxDirect multiplex PCR reagent kit.
"We are now focused on gaining [US Food and Drug Administration] approval for the MCD in conjunction with our Modular Immune Profile assay for home testing of systemic lupus erythematous patients," DxTerity CEO. Bob Terbrueggen said in a statement. "Regular monitoring of autoimmune patients will allow physicians and patients to more effectively manage their disease and spot potential disease flares before they happen."
According to Rancho Dominguez, California-based DxTerity, the Modular Immune Profile assay is designed to measure the relative expression of 51 genes grouped into modules correlated with immune pathways and therapeutic targets. It is currently available for investigational use only.