Reporting test results

Will you reanalyze my sample/data if my test is negative?

The laboratory is able to reanalyze a patient’s previous genomic data at the request of a physician.  Additional testing will result in additional costs to the patient.

How do you follow-up test results? Who pays for this?

It is recommended that results of the test be discussed with the ordering physician.  A consultation with a clinical geneticist or genetic counselor may be valuable.  This discussion is part of routine medical care and is generally covered by insurance.  Ultimately, verifying insurance coverage is the patient’s responsibility and we recommend that you verify insurance coverage and determine any amounts that you may be responsible for paying with your insurance company.

Will parents get a separate report?

When genomic testing of a patient includes parents and/or other family members all information is included in the patient’s report.  This means that the patient may become aware of a family member’s testing results.  There is no separate report for family members.  Additionally, family members who are tested will not be notified of their results by the laboratory, even if variants are found.

What is included in the report?

A laboratory report includes primary findings (those DNA changes related to the patient’s medical condition).  Inheritance of these types of results are included in the report.

Secondary or incidental findings requested by the patient or the patient’s parents/legal guardians as they relate to the patient may also be included in the report. If parent(s) provided separate consent documenting that they wish to have inheritance of patient variants disclosed then this will be included in the patient's report (no separate reports for parents/family members are issued).

How long will you keep my data and or sample and how will my data be stored?

DNA samples and genomic data are stored in accordance with Wisconsin law (currently requires storage of data for 3 years).

How do you follow-up test results? Who pays for this?

It is recommended that results of the test be discussed with the ordering physician.  A consultation with a clinical geneticist or genetic counselor may be valuable.  This discussion is part of routine medical care and is generally covered by insurance. Ultimately, verifying insurance coverage is the patient's responsibility and we recommend that you verify insurance coverage and determine any amounts that you may be responsible for paying with your insurance company.

Can I change my mind about what is included in the report after my test has started?

Reporting choices may be changed prior to the start of sequencing. Once a sample has been sequenced the test reporting cannot be altered. For details please contact the Children's Wisconsin Laboratory.

How is my genomic data protected?

Genomic data like all laboratory medical data is protected by law as described in HIPAA (Health Insurance Portability and Accountability Act of 1996) and GINA (Genetic Information Nondiscrimination Act).

Who makes decisions regarding what to report?

A laboratory report includes primary findings (those DNA changes related to the patient’s medical condition) and secondary or incidental findings requested by the patient or the patient's parents/legal guardians. This report will go into the patient's medical record. The laboratory director determines which DNA changes may explain the patient's medical condition and which DNA changes fit the categories of secondary/incidental findings requested.

Do you offer pharmacogenetic analysis in the results?

The laboratory does not currently evaluate the data for pharmacogenetic variants.

Do you report common disease risk?

The laboratory does not currently evaluate the data for common disease risk such as risk for hypertension or diabetes.

Will you report common disease risk in the future?

Yes.

What if parents disagree on reporting categories, who makes final decision?

Genomic testing is like any other laboratory test. Providers should abide by applicable state laws with respect to parents and their rights to request/withhold testing.

How do I get counseling for my patient?

Genetic counseling concerning genomic sequencing is available at Children's Wisconsin in the Genomic Medicine Clinic.