Is the IIHG CAP certified?

Yes. The IIHG Clinical Diagnostics Division is a CLIA certified (CLIA ID: 16D2053873), CAP accredited laboratory (CAP# 8864771).

Is this test FDA approved?

The IIHG Clinical Exome Test is a laboratory developed test.

The performance characteristics of this test were validated by IIHG laboratories. The US Food and Drug Administration (FDA) has not approved or cleared this LDT, however FDA approval or clearance is currently not required for clinical use of this test. These results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. IIHG is authorized under the Clinical Lab Improvement Act (CLIA) to perform highly complex testing.

Do I need to order a test kit prior to ordering the test?

No, all of the required forms can be downloaded from our website, and standard EDTA (lavender) tubes can be used. However, if you may contact us to receive a test kit (blood tube, forms, FedEx) if you wish.

Does the IIHG perform insurance verification/preauthorization?

Insurance verification/preauthorization is now available for patients seen at UI Health Care.

Do you accept credit card billing or direct patient payment?

Yes. Institutional billing, Visa and MasterCard are accepted.

Can I get my patient’s results faster than the published turnaround time?

No. The turnaround time is three months.

Why is genetic counseling recommended for this test?

Whole exome sequencing identifies thousands of variants in a patient’s genome. Due to the complexity of the genetic information genetic counseling is recommended to assist the patient in understanding the benefits and limitations of the test. In addition, although efforts are made to limit reporting of variants of unknown clinical significance, incidental findings and variants of unknown clinical significance may be identified. A genetic counselor can assist in explaining these results to patients.

Can I find out before ordering the test how well specific genes are covered by this test?

Yes, you can check if genes are captured by the Agilent SureSelect v5 exome capture, and how well those genes are typically covered. Please email iihg@uiowa.edu for more information.

Is the mitochondrial genome analyzed as part of this test?

The mitochondrial genome is analyzed if mitochondrial inheritance is suspected.

Why are complete clinical and family history information necessary to interpret my patient’s results?

Clinical whole exome sequencing identifies thousands of variations in the human genome. The IIHG performs symptom-guided analysis of these variants for interpretation of the data. The clinical and family history recorded by the ordering physician provides the necessary information for the IIHG Clinical Exome Interpretation team to accurately interpret the variations identified in a patient’s exome, and increases the likelihood of identifying the causative variant(s).

How are results returned to me?

• Results will be returned to the ordering physician and genetic counselor by fax
• We do not return results over the phone

What is reported?

• Genes analyzed based on the clinical history provided by the ordering physician (Symptom Candidate Gene List).
• Pathogenic variants identified in genes which may be responsible for the patient’s symptoms as reported by the ordering physician. The IIHG Clinical Diagnostics laboratory utilizes the ACMG Recommendations for standards for interpretation of sequence variations (Richards et al. GenetMed 2008;10:294-300). Variants must fulfill the ACMG criteria for pathogenic or likely pathogenic to be included in the report.
• Regions of the Symptom Candidate Gene List which were not captured by the current exome capture platform.
• Regions of the Symptom Candidate Gene List which were not sequenced to a sufficient depth of coverage to make a clinical diagnosis.

What is not reported?

• Variants unrelated to the patient’s symptoms as reported by the ordering physician
• Variants of uncertain significance
• Family members who submit samples for interpretation of the patient’s sample will not receive a separate written report.
• Secondary findings
• Non-paternity

Will the report contain medical advice?

No, the report does not contain medical advice, as the ordering physician will interpret the test results within the clinical context.

What if extended family members want to be tested?

If a causative variant is identified by the IIHG, extended family members can be tested for the same variant for a charge. Such individuals will need to complete the clinical consent, requisition, clinical and billing information. Please contact the IIHG laboratory at iihg@uiowa.edu, tel: (319) 335-3688 for arrangements, and also see our website for the CPT code.

Can someone not in Iowa participate in one of the seminars or courses?

• Yes, if there is a course you would like to participate in, please contact the IIHG at iihg@uiowa.edu.
• Select seminars will also be available online through our website, www.medicine.uiowa.edu/humangenetics.