About Our Tests
ClearID liquid biopsy testing is designed to provide targeted, minimally invasive tumor cell analysis for patient assessment and monitoring. The tests are powered by Cynvenio’s LiquidBiopsy approach to tumor monitoring, which can examine circulating tumor cells (CTCs), cell-free DNA (cfDNA) and germline DNA (gDNA) to provide a clear distinction between tumor and germline. This approach offers a far more complete view of a patient’s cancer landscape and can be used in conjunction with traditional tissue biopsies for the most comprehensive analysis.
ClearID is able to detect genetic mutations on a few as 5 cells per billion. The test looks beyond traditional tumor biomarkers like CA 15-3, and interrogates a comprehensive panel of genes, including oncogenes and tumor suppressor genes, that are frequently altered with tumor progression and can be used to provide a snapshot molecular profile of the patient’s tumor. This information can help to inform clinical decision-making and provide information about appropriate targeted therapies and available clinical trials that match the abnormalities found.
+ ClearID test specifications
ClearID provides a genomic fingerprint of the specific molecular pathways that are driving tumor growth in an individual patient. Via next generation sequence analysis of tumor DNA isolated from whole blood, ClearID also detects genetic alterations that may be targetable by anti-cancer drugs without the need for additional biopsy material.
- False positive rate: The false positive rate is the number of healthy individuals without any disease that test positive. For ClearID the false positive rate is negligible (less than 0.0014%).
- False negative rate: The false negative rate is the number of individuals with disease that test negative. The false negative rate for ClearID is zero for patient samples known to have a mutation that is addressable. However, not every individual with disease will have target cells or mutations identifiable by this test.
- Sensitivity and specificity: For ClearID Breast Cancer and the ClearID Solid Tumor panel, specificity is 100% and sensitivity is 98.4%. For ClearID Lung Cancer, specificity is >98% and sensitivity is 95.9%.
+ Relevant cancer types
Currently available ClearID panels are listed below. Additional target oncogene panels are in development. ClearID testing can be used at intervals during and after treatment.
+ Analysis and reporting
Within 3-14 days of specimen receipt, you will receive a clear, concise genomic report tailored to the patient’s tumor and unique molecular profile. The report is clinically relevant, curated by leading independent clinical practitioners, and includes references to specific medical literature, and information on how identified mutations can be targeted by existing therapies, drugs in development, and active clinical trials. The report also leverages a database with clinical interpretations of hundreds of biomarkers, thousands of variants and their associations with drugs, clinical trials and experimental therapies.
The Report Includes:
Results Summary - At-a-glance summary of cancer-associated mutations found in CTC and/or cfDNA.
Genomic Alterations - High-level description of each variant identified by the test, fully referenced.
Therapies - A listing of relevant drug therapies available plus new and standard of care treatment approaches.
Clinical Trials - Comprehensive information on clinical trials addressing the mutation(s) identified.
Bibliography - Supporting medical evidence contextualized by a network of oncologist and researchers.
Download a ClearID Sample Report →
Download a PD-L1 Sample Report →
Download a HER2 Sample Report →
+ Testing recommendations
Testing recommendations and frequency of testing will vary by patient. The patient testing schedule is determined by the treating physician.
+ ClearID vs. tissue biopsy
For the patient, ClearID is far less invasive and painful, and is available at a much lower cost. A simple blood draw is the only procedure required for ClearID testing. ClearID is also significantly more accurate and objective than tissue-based analysis, with a negligible false-positive rate (less than 0.0014%) and a false-negative rate of zero among patients with a mutation that is addressable. However, there are cases in which a patient will not have cancer cells or mutations identifiable by ClearID.
+ Certifications and test validation
Our laboratory is federally regulated under College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) standards, and managed by a medical director who is also a licensed pathologist. Our testing and analysis process have also been clinically validated on over 8,000 blood samples from both healthy donors and cancer patients obtained via clinical research collaborations with major cancer centers in the U.S.
+ Ordering Tests
Sample collection kits are available from Cynvenio and include everything needed to collect and ship a blood sample. Once blood is drawn, the sample is stable for up to 4 days at ambient temperature for transfer to Cynvenio for processing. Depedning on the test ordered, results are provided to the ordering physician within 3-14 days of the receipt of the specimen.
Order test kits by submitting the form on this website, or call us at 888-885-1172.
+ Insurance and Billing
Cynvenio accepts most insurance plans, and will directly bill the insurance company. Patients are also invited to take advantage of our ClearBilling program, which offers a host of convenient features plus aid for those without financial means. Our goal is to ensure that every patient who can benefit from ClearID has access to the test regardless of circumstance. Contact us for more information.