Artera
Precision-medicine company developing AI-enabled diagnostic tests that combine digitized histopathology whole-slide images and structured clinical data to generate prognostic and predictive biomarkers for cancer therapy decision-making. Operates a CLIA-certified laboratory for laboratory-developed tests, maintains security and compliance controls, and supports clinician ordering, reporting, and reimbursement workflows.
Industries
Nr. of Employees
medium (51-250)
Products
AI-enabled prostate biopsy prognostic and predictive test
Laboratory-developed test that analyzes digitized prostate biopsy whole-slide images and clinical data to estimate risk of distant metastasis and predict benefit from treatments such as short-term hormone therapy, supporting personalized treatment planning for localized disease.
AI-enabled post-prostatectomy (Post-RP) prognostic and predictive test
Test applied to digitized prostatectomy surgical specimen images and clinical data to estimate long-term outcomes and predict benefit from adjunct treatments (e.g., short-term hormone therapy alongside salvage radiation) for patients with biochemical recurrence after radical prostatectomy.
AI-enabled metastatic hormone-sensitive prostate cancer (mHSPC) prognostic test
Test that provides individualized 5-year prostate cancer–specific mortality risk estimates for patients with metastatic hormone-sensitive prostate cancer to inform treatment intensity and duration decisions (doublet versus triplet therapy considerations).
AI-enabled breast cancer prognostic and predictive test (HR+/HER2-)
Laboratory-developed test combining digitized resection slide images and clinical data to estimate 5- and 10-year distant metastasis risk and predict chemotherapy benefit for defined early-stage HR+/HER2- breast cancer cohorts.
AI-enabled prostate biopsy prognostic and predictive test
Laboratory-developed test that analyzes digitized prostate biopsy whole-slide images and clinical data to estimate risk of distant metastasis and predict benefit from treatments such as short-term hormone therapy, supporting personalized treatment planning for localized disease.
AI-enabled post-prostatectomy (Post-RP) prognostic and predictive test
Test applied to digitized prostatectomy surgical specimen images and clinical data to estimate long-term outcomes and predict benefit from adjunct treatments (e.g., short-term hormone therapy alongside salvage radiation) for patients with biochemical recurrence after radical prostatectomy.
AI-enabled metastatic hormone-sensitive prostate cancer (mHSPC) prognostic test
Test that provides individualized 5-year prostate cancer–specific mortality risk estimates for patients with metastatic hormone-sensitive prostate cancer to inform treatment intensity and duration decisions (doublet versus triplet therapy considerations).
AI-enabled breast cancer prognostic and predictive test (HR+/HER2-)
Laboratory-developed test combining digitized resection slide images and clinical data to estimate 5- and 10-year distant metastasis risk and predict chemotherapy benefit for defined early-stage HR+/HER2- breast cancer cohorts.
Services
Provision of clinically available AI-enabled prognostic and predictive tests processed in a CLIA-certified high-complexity laboratory; includes specimen handling, slide digitization, AI analysis, quality controls, and clinician report generation.
Web-based portal account setup for ordering clinicians and authorized delegates to submit orders, track status, and access test reports; customer success coordinates logistics with pathology laboratories.
Benefit investigation, claims and appeals support, Medicare Part B guidance, and administration of a financial assistance program with eligibility tiers and payment-plan options to reduce patient out-of-pocket costs.
Structured programs that provide select clinicians and research collaborators early access to test reports and opportunities to provide feedback during test rollout or report format updates.
Support to add the AI-enabled test to orders placed through partner genomic or laboratory platforms to simplify ordering for clinicians using partner ecosystems.
Provision of clinically available AI-enabled prognostic and predictive tests processed in a CLIA-certified high-complexity laboratory; includes specimen handling, slide digitization, AI analysis, quality controls, and clinician report generation.
Web-based portal account setup for ordering clinicians and authorized delegates to submit orders, track status, and access test reports; customer success coordinates logistics with pathology laboratories.
Benefit investigation, claims and appeals support, Medicare Part B guidance, and administration of a financial assistance program with eligibility tiers and payment-plan options to reduce patient out-of-pocket costs.
Structured programs that provide select clinicians and research collaborators early access to test reports and opportunities to provide feedback during test rollout or report format updates.
Support to add the AI-enabled test to orders placed through partner genomic or laboratory platforms to simplify ordering for clinicians using partner ecosystems.
Expertise Areas
- Digital pathology AI for prognostic and predictive biomarker development
- Clinical validation using randomized Phase III trial cohorts
- Clinical laboratory operations for high-complexity LDTs (CLIA)
- Regulatory strategy and SaMD authorization pathways
Key Technologies
- Multimodal deep learning for histopathology and clinical data
- Whole-slide digital imaging and image preprocessing
- Cloud-based analytics infrastructure
- Secure data transmission and encryption (AES-256)
News & Updates
Company presentations and abstracts at major meetings covering model validation, clinical utility, and cohort analyses.
Press coverage reporting on regulatory authorization activities for AI-based prostate cancer diagnostics.
Received De Novo marketing authorization from the US FDA for an AI-based digital pathology risk-stratification software regulated as Software as a Medical Device.
Previously granted Breakthrough Device designation for an AI-powered prostate cancer diagnostic software.
The prostate predictive test is cited as a recommended predictive test in relevant clinical practice guidelines for prostate cancer.
Completion of annual independent SOC 2 Type II examinations to assess design and operating effectiveness of information security controls (effective July 2026).
Company presentations and abstracts at major meetings covering model validation, clinical utility, and cohort analyses.
Press coverage reporting on regulatory authorization activities for AI-based prostate cancer diagnostics.
Received De Novo marketing authorization from the US FDA for an AI-based digital pathology risk-stratification software regulated as Software as a Medical Device.
Previously granted Breakthrough Device designation for an AI-powered prostate cancer diagnostic software.
The prostate predictive test is cited as a recommended predictive test in relevant clinical practice guidelines for prostate cancer.
Completion of annual independent SOC 2 Type II examinations to assess design and operating effectiveness of information security controls (effective July 2026).