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No. The IIHG Clinical Diagnostics
Division is a CLIA certified (CLIA ID: 16D2053873), Joint Commission
Accredited laboratory. The Clinical Diagnostic Division standards were
established based on 2012 CAP Molecular Pathology guidelines.
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
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.
No, at this time the IIHG does not perform insurance verification/preauthorization.
Not yet. At this time the IIHG only accepts institutional billing. Additional payment options are in development.
No. The turnaround time is three months.
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.
The mitochondrial genome is analyzed if mitochondrial inheritance is suspected.
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
No, the report does not contain medical
advice, as the ordering physician will interpret the test results within
the clinical context.
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 email@example.com, tel: (319) 335-3688 for arrangements, and
also see our website for the CPT code.