custom diagnostics
Scalable diagnostic development
Contact Us
Driving the future ofclinical decisions
Clinical Trial Assays (CTA) and Companion Diagnostics (CDx) for pharmaceutical companies and diagnostic partners
Concept through commercialization
DxTerity partners with institutions to develop RNA-based diagnostics—from assay design through regulatory submission.
From Patient to Practice
DxTerity has focused on patient needs for simplicity and access and providers to assure stringent quality and responsiveness.
Our capabilities
Assay Design
Custom oligonucleotide design and targeted panels to fit a variety of assay needs.
Analytical Validation
Study design and sample acquisition to allow for robust analytical studies
Clinical Studies
Identification of clinical patient population and unique abilities to include testing from home or clinic
Regulatory Guidance
Expertise in diagnostic development under design control for FDA and IVDR applications
Manufacturing
Integrated full scale manufacturing for kits and blood collection products meeting stringent quality standards.
Data Management
Full data management with our QSR system allowing protection and delivery of sample results and clinical trial end points
FDA compliant product development
A unique analytical process that eliminates sample purification and enables high-throughput processing for RNA based tests.
phase 1
Product Development
phase 1
Product Development
RNA biomarker/CDx strategy aligned to drug label and clinical trials
510(k)/PMA/de novo pathway selection
Phase-gate timelines
Design inputs → outputs with DxDirect-specific protocols and controls
Full DHF, risk management (ISO 14971), and design review documentation
phase 2
Design Transfer
phase 3
Verification
phase 4
Validation
phase 5
Submission & Authorization
Clinical Partners
Collaborations
Driving Innovation
Our clinical research platform connects partners with patient participants for studies advancing precision medicine.
Partnering with patients
DxTerity is proud to be a member of the Lupus Landmark Study, helping to accelerate personalized treatments for lupus. This work closely collaborates with patient groups and advocacy organizations to develop tests with the patient in mind. As the largest study of its kind in lupus, the Lupus Landmark Study will follow 3,500 adults diagnosed with systemic lupus erythematosus (SLE). The study is a key element of the Lupus Nexus, a state-of-the-art, patient-centric, collaborative research resource.
Learn more
Partnering with biopharma & academia
DxTerity connects biopharma and academic partners with patients to advance precision medicine in immune-mediated diseases.
Partnering for growth
“The patients, physicians and industry needs standardized testing that can give insights into precision medicine. One with robust validation and design control .”
Biopharma Partner
Partner with Us
Contact our team to learn about testing solutions
Contact Us
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.
custom diagnostics
Scalable diagnostic development
Contact Us
Driving the future ofclinical decisions
Clinical Trial Assays (CTA) and Companion Diagnostics (CDx) for pharmaceutical companies and diagnostic partners
Concept through commercialization
DxTerity partners with institutions to develop RNA-based diagnostics—from assay design through regulatory submission.
From Patient to Practice
DxTerity has focused on patient needs for simplicity and access and providers to assure stringent quality and responsiveness.
Our capabilities
Assay Design
Custom oligonucleotide design and targeted panels to fit a variety of assay needs.
Analytical Validation
Study design and sample acquisition to allow for robust analytical studies
Clinical Studies
Identification of clinical patient population and unique abilities to include testing from home or clinic
Regulatory Guidance
Expertise in diagnostic development under design control for FDA and IVDR applications
Manufacturing
Integrated full scale manufacturing for kits and blood collection products meeting stringent quality standards.
Data Management
Full data management with our QSR system allowing protection and delivery of sample results and clinical trial end points
FDA compliant product development
A unique analytical process that eliminates sample purification and enables high-throughput processing for RNA based tests.
phase 1
Product Development
phase 2
Design Transfer
phase 3
Verification
phase 4
Validation
phase 5
Submission & Authorization
phase 1
Product Development
RNA biomarker/CDx strategy aligned to drug label and clinical trials
510(k)/PMA/de novo pathway selection
Phase-gate timelines
Design inputs → outputs with DxDirect-specific protocols and controls
Clinical Partners
Collaborations
Driving Innovation
Our clinical research platform connects partners with patient participants for studies advancing precision medicine.
Partnering with patients
DxTerity is proud to be a member of the Lupus Landmark Study, helping to accelerate personalized treatments for lupus. This work closely collaborates with patient groups and advocacy organizations to develop tests with the patient in mind. As the largest study of its kind in lupus, the Lupus Landmark Study will follow 3,500 adults diagnosed with systemic lupus erythematosus (SLE). The study is a key element of the Lupus Nexus, a state-of-the-art, patient-centric, collaborative research resource.
Learn more
Partnering with biopharma & academia
DxTerity connects biopharma and academic partners with patients to advance precision medicine in immune-mediated diseases.
Partnering for growth
“The patients, physicians and industry needs standardized testing that can give insights into precision medicine. One with robust validation and design control .”
Biopharma Partner
Partner with Us
Contact our team to learn about testing solutions
Contact Us
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.