1. Subject is male or female > 18 years of age.
2. Subject has an untreated primary malignancy of breast, lung, colorectal, prostate,
bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or
Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal
pelvis, or ovarian cancer based on imaging.
3. Subject understands the study procedures and is able to provide informed consent to
participate in the study and authorization for release of relevant protected health
information to the study Investigator.
1. Prior or concurrent cancer diagnosis defined as:
1. Any previous cancer diagnosis within the past 5 years (with the exceptions of
basal cell or squamous cell skin cancers); OR
2. Recurrence of the same primary cancer within any timeframe; OR
3. Concurrent diagnosis of multiple primary cancers
2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample
3. Any treatment for the primary malignancy or sites of metastases. Subject may not have
started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or
other treatment and/or surgery prior to blood sample collection.
4. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood
5. Less than 7 days between biopsy (other than FNA) of target pathology and blood
6. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
7. Individual has a condition the Investigator believes would interfere with his or her
ability to provide informed consent, comply with the study protocol, which might
confound the interpretation of the study results or put the person at undue risk.