Devices Diagnostics Regulatory

 News Release - March 3, 2020

DxTerity Receives CE Mark for DxCollect(R) Fingerstick Blood RNA Stabilization Device

DxTerity device enables from home, gene expression monitoring of patients

LOS ANGELES, March 3, 2020 -- (Healthcare Sales & Marketing Network) -- DxTerity Diagnostics has declared conformity with the requirements of the European In Vitro Diagnostic Directive (98/79/EC) and has applied the CE mark to the DxCollect® MicroCollection Tube (MCD) for the collection and preservation of finger stick blood for RNA and DNA testing.

The DxCollect MCD allows for stabilization and transport of 100 microliters of blood that is collected from a finger prick and shipped at ambient for DNA and RNA based genomic testing. Unlike DNA testing which can be performed from spit or a cheek swab, RNA-based genomic testing usually requires a blood sample that is collected into specialized tubes and often shipped on dry ice. DxTerity's DxCollect MCD provides robust stabilization at room temperature and specimens can be shipped under ambient conditions using standard mail.

The DxTerity device has been successfully deployed in large scale, direct-to-patient clinical studies and it is currently being used by multiple pharmaceutical companies for patient stratification and monitoring.

"We are excited to announce this regulatory milestone and we are now focused on gaining FDA approval for the MCD in-conjunction with our Modular Immune Profile Assay for home testing of systemic lupus erythematous (SLE) patients," says Dr. Bob Terbrueggen, CEO of DxTerity. "In much the way that diabetes patients can fine-tune their insulin levels based on routine self-monitoring, regular monitoring of autoimmune patients will allow physicians and patients to more effectively manage their disease and spot potential disease flares before they happen."

About DxTerity

DxTerity is a molecular information and diagnostics company bringing precision medicine to autoimmune treatment with from-home RNA monitoring. DxTerity also provides services and technologies to partner organizations, including population-scale genomic studies. For more information, please visit DxTerity.com.

Source: DxTerity Diagnostics

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