HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)

Patients with clinically-diagnosed cirrhosis without HCC (Group 1) and patients with
early-stage HCC (Group 2) will be invited to participate in this study consisting of one
visit for all subjects. At Visit 1, Day 0, after subjects have provided informed consent and
HIPAA consent, demographics (age, gender, ethnicity), etiology of liver disease and medical
history as well as a list of current medications will be obtained; inclusion and exclusion
criteria will be reviewed; and subjects will be registered into the study and will undergo a
venipuncture to obtain four (4) lavender top K2 ethylenediaminetetraacetic acid (EDTA) 10
millilitre (mL) tubes of blood.

The HCCBloodTest will be performed on the blood samples collected from study subjects by the
Sponsor at its laboratory in Berlin, Germany, to determine the performance characteristics of
the HCCBloodTest in the study population.

The HCCBloodTest is an in-vitro polymerase chain reaction (PCR) assay for the qualitative
detection of Septin 9 gene methylation (SEPT9) in DNA isolated from 3.5 mL of patient plasma.
The SEPT9 gene is a key regulator of cell division and tumor suppressor and the
hypermethylation of the assessed marker site is associated with liver carcinogenesis.

Results from the HCCBloodTest will be not be provided to the investigators or study subjects
and, therefore, will be not be used in clinical decision-making or impact clinical care of
the study participants in any manner.

Inclusion Criteria:

- Men or women age 18 years or older;

- Able to read, understand and sign informed consent to participate in study;

- Willing and able to provide written informed consent;

- Willing and able to meet all study requirements and undergo venipuncture to provide
blood samples;

- Child-Pugh Score of A or B.

Group 1:

• Diagnosis of cirrhosis and no HCC confirmed by medical imaging including MRI or CT
performed within 6 months of study enrollment. If lesions are present, a LI-RADS score of
LR-1 or LR-2.

Group 2:

• Diagnosis of HCC confirmed by medical imaging (MRI or CT performed within 6 months of
study enrollment with LI-RADS score of LR-5) and/or biopsy with histopathology.

Exclusion Criteria:

Both Groups:

- Child-Pugh Score of C;

- Subject has undergone a colonoscopy, endoscopy or other invasive diagnostic procedure
(other than venipuncture) during the 10 days prior to providing a blood sample for
this study;

- Pregnancy;

- Breastfeeding;

- Currently undergoing dialysis;

- Currently receiving investigational treatments of any type;

- History of receiving any drug therapy, surgery or liver transplant for the treatment
of HCC;

- Diagnosis of any non-HCC cancer (other than non-melanoma skin cancer) within past 5
years and/or currently undergoing treatment for any cancer;

- Any clinical condition, diagnosis, or social circumstance that, in the opinion of the
Investigator, would be mean participation in the study would be contraindicated.