REPLACED BY V5 on AUGUST 31, 2022

Instructions: Please complete the following tables and answer the following questions as appropriate. Indicate "N/A" when not applicable.

NOTE: There are 10 Sections in this form.

1 - DEX Z-CodeTM Identifier:

2 - List indications for use (list the cancer type(s) indicated for use of this test, add rows if necessary):

3a- Is this test utilizing an FDA-approved or cleared kit?

If yes, please provide the vendor and kit name:

3b-Is this test utilizing a non FDA-approved commercial kit?

If yes, please provide the vendor and kit name:

4 - Preanalytical Questions

1. What are the sample types accepted for testing?

2. Is a trio or comparator required for analysis?

3. Describe orthogonal methods used for confirmation of the clinical validation:

1. Describe the library quality criteria for reporting:

2. Describe variant quality criteria for reporting:

3. What is the mean depth of coverage across validation samples:

4. What is your minimum accepted mean depth of coverage for a clinical sample:

5. Describe non-NGS methodologies used to cover complex regions:

1. Who reviews and signs out these test results?

2. How are controls utilized in this test?

3. How do you ensure specimen integrity/ minimize contamination?

4. How do you handle negative or QNS reports?

5. How do you handle amended and corrected reports?

7 - Sample Types Tested in Clinical Validation

List the samples (or controls) used for the validation and number used. Add rows to describe "Other" sample types, if necessary.

Number of Samples Tested

Total clinical samples in validation

Total samples in validation

*Reference material are not considered "clinical" and do not contribute to the assessment of the clinical validation.

8 - Analytical validation summary table

2 For the purposes of this table, a splice-site variant is defined as a variant that is detected by analyzing RNA transcripts.

3 For the purposes of this table, a “unique variant” may include the same variant [e.g., BRCA1 c.4327C>T (p.Arg1443Ter)] in different unique samples.

Complete the table below, add more lines if necessary

NOTE: genes are ONLY required for tests where the cancer type listed is included in the intended use of the test.