This document provides information about Fusion HCC Predictor test. It should supplement any discussions with a healthcare provider regarding the purposes, benefits, risks, and limitations of the test. The test can be ordered by licensed healthcare providers and individuals needing screening of early-stage liver cancer, and undergoing th e test is your choice. We encourage you to ask any questions you may have about this test.

Purpose of the Test

Fusion HCC Predictor test is for early detection for cancer. Fusion HCC Predictor test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older or individuals with liver cancer risk. Fusion HCC Predictor test can screen for liver cancers before they become symptomatic, including those with no recommended screening tests today. Cancers growing in the body shed RNA into the bloodstream.

When cancer cells grow, the R NA fragments act like a unique "fingerprint" of cancer. With this unique "fingerprint" of cancer, the Fusion HCC Predictor test helps to provide direction to your healthcare provider on the location of the cancer, so that your provider can determine what additional tests are needed to confirm if cancer is present.

Testing Process and Results

MoleculeDx INC, the company that created and performs the Fusion HCC Predictor test, will test your blood sample to look for R NA shed into the bloodstream that may have come from cancer. There are three possible results: “HIGH risk signals of hepatocellular carcinoma DETECTED","High risk signals of hepatocellular carcinoma NOT detected” or “Canceled”. A result of high risk signals of hepatocellular carcinoma DETECTED is not a diagnosis of cancer.

With this result, your healthcare provider will determine what additional tests are needed to confirm if cancer is present. These tests may include additional imaging or biopsy. A result of high risk signals of hepatocellular carcinoma NOT detected does not rule out cancer. It is important that you continue to receive any cancer screening tests that your healthcare provider recommends as part of your usual medical care.

Canceled reports are infrequent, but can occur if samples did not satisfy quality measures during processing. MoleculeDx INC will provide your test results to your ordering healthcare provider. MoleculeDx INC also will provide your test results to you by email directly. In that case, please note that you may receive your results before your provider. If you are having trouble receiving or accessing your test results, you may contact MOLECULEDX INC Customer Service at 412-385-2581 or info@moleculedx.com.

Limitations of the Test

Fusion HCC Predictor test does not detect all liver cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Use of Fusion HCC Predictor test is not recommended in individuals who are pregnant, 21 years old or younger. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms.

A test result high risk signals of hepatocellular carcinoma DETECTED of hepatocellular carcinoma NOT detected does not rule out cancer. A test result of high risk signals of hepatocellular carcinoma DETECTED requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer.

If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False positive (a cancer signal detected when cancer is not present) and false negative (a cancer signal not detected when cancer is present) test results do occur.

Laboratory/Test Information

The MoleculeDx INC clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the Commission on Laboratory Accreditation. The Fusion HCC Predictor test was developed and its performance characteristics were determined by MoleculeDx INC. The Fusion HCC Predictor test has not been cleared or approved by the Food and Drug Administration. The MoleculeDx INC clinical laboratory is regulated under CLIA to perform high-complexity testing.

The Fusion HCC Predictor test is intended for clinical purposes. This document provides information about Fusion HCC Predictor test. It should supplement any discussions with a healthcare provider regarding the purposes, benefits, risks, and limitations of the test. The test can be ordered by licensed healthcare providers, and undergoing this test is your choice. We encourage you to ask any questions you may have about this test.

Disclosure and Use of Test Results & Health Information

Your Fusion HCC Predictor test results and health information are confidential. Your test results and other health information will only be collected, used, or disclosed in compliance with the Health Insurance Portability and Accountability Act ("HIPAA"), as detailed in MoleculeDx INC Notice of Privacy Practices (MoleculeDx INC.com/hipaa).

MoleculeDx INC may disclose your health information to:

• Your healthcare providers (or their designated representatives);
• Your health insurance company (if the MoleculeDx INC test, or any follow-up diagnostic care, is paid for, partially or in full, by your health insurance company); and/or
• As otherwise described in MoleculeDx INC’s Notice of Privacy Practices

You may also request your Fusion HCC Predictor test results by contact ing MoleculeDx INC Customer Service at 412-385-2581 or info@moleculedx.com. However, given the complex nature of genetic testing, we strongly recommend that you obtain the clinical results directly from your healthcare provider and that you discuss test results with your healthcare provider.

Secondary Data Uses

In compliance with HIPAA, MoleculeDx INC may de-identify your health information (including your test results and certain follow-up clinical information). "De-identification" means that all information that could be used to readily identify you, such as your name, address, and date of birth, is removed from your data so that the risk of identifying you is very low.

MoleculeDx INC may use and disclose your de-identified information for the following: laboratory process and quality-related activities, product development and verification activities, and research and development activities. In order to accomplish these secondary uses, MoleculeDx INC may sometimes link multiple de-identified datasets, some of which may be collected from third party data sources, such as healthcare claims databases.

Linked datasets will remain de-identified in accordance with HIPAA de-identification standards so the risk of identifying you remains very low. To the extent MoleculeDx INC uses identifiable data for research purposes, we would do so only in compliance with HIPAA and subject to review and approval by a committee responsible for ensuring the protection and privacy of research participants.

Retention of Samples

By agreeing to the MoleculeDx INC test, you release your rights to the biological samples collected and any results generated from the testing. MoleculeDx INC may choose to destroy the sample at the end of the testing process or retain it indefinitely. MoleculeDx INC may de-identify your blood sample and use such sample for the purposes described under "Secondary Data Uses" above, to the extent allowed by applicable law.

You are not entitled to compensation for the use of your blood sample or rights to any products or discoveries resulting from use of your blood sample. If you do not want your leftover blood sample to be retained or used in the manner described in this document, you may request that your sample be destroyed by contacting MoleculeDx INC Customer Service at 412-385-2581 or info@Moleculedx.com within 60 days after you receive your MoleculeDx INC test result.

Patient Acknowledgement

By requesting the MoleculeDx INC test, I confirm that I have read this patient information sheet and any other information provided to me by MoleculeDx INC or the ordering healthcare provider, including the purpose, risks, benefits, and alternatives of this test. I have discussed any questions I may have with the ordering healthcare provider, and I understand that if I have any future questions or concerns related to this test, I will speak with the ordering healthcare provider.

I understand that my leftover blood sample may be retained indefinitely by MoleculeDx INC unless I request its destruction. I hereby agree to take part in this testing. I understand that I will be given a copy of this form to keep for my records.