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February 27, 2020
May 14, 2026
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DxTerity Receives CE Mark for DxCollect® Fingerstick Blood RNA Stabilization Device
LOS ANGELES, CA – February 27, 2020 – 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.
www.dxterity.com
DxTerity Contact:
Jim Healy
DxTerity Diagnostics Inc.
310-537-7857
info@dxterity.com
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DxTerity’s patient-focused mission is to bring the power of at-home RNA-based genomic monitoring to improve the management of immune-mediated diseases and overall patient well-being.
← Back
Research
•
February 27, 2020
DxTerity Receives CE Mark for DxCollect® Fingerstick Blood RNA Stabilization Device
LOS ANGELES, CA – February 27, 2020 – 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.
www.dxterity.com
DxTerity Contact:
Jim Healy
DxTerity Diagnostics Inc.
310-537-7857
info@dxterity.com
Related articles
Research
•
May 14, 2026
Precision Medicine using Modular Genomics
A simple look at how RNA-based testing can help uncover patterns in immune system activity and support more informed care decisions.
Research
•
February 27, 2020
DxTerity Receives CE Mark for DxCollect® Fingerstick Blood RNA Stabilization Device
Learn how patient-friendly testing can reduce barriers, improve convenience, and help people stay more connected to their health journey.
•
May 18, 2022
DxTerity Receives New York Authorization for Type 1 Interferon (IFN-1) for Systemic Lupus Erythematosus
IFN-1 gene signature testing represents the advancement of precision medicine beyond cancer in autoimmune disease
Stay in the know.
Get the latest updates and news.
DxTerity’s patient-focused mission is to bring the power of at-home RNA-based genomic monitoring to improve the management of immune-mediated diseases and overall patient well-being.