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KidneySeq FAQ

KidneySeqTM FAQ

  1. What certifications does the IIHG have?
    1. The IIHG is currently accredited through the College of American Pathologists (CAP) laboratory certification program and CLIA compliant.
  2. Is this test FDA approved?
    1. These tests were developed, and their performance characteristics determined by the Clinical Diagnostics Division of the Iowa Institute of Human Genetics. these tests have not been cleared or approved by the U.S. Food and Drug Administration (21 CFR§ 809.30 [e]. FDA does not require this test to go through premarket FDA review. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. 
  3. Do I need to order a test kit prior to ordering the test? 
    1. No, the required requisition can be downloaded from our website, and standard lavender (EDTA) tubes can be used. 
  4. How was the cost of the test determined? 
    1. Cost was determined based on resources used, reagents, machine usage, data storage, and labor.
  5. Does the IIHG perform insurance verification/preauthorization? 
    1. No, currently the IIHG does not perform insurance verification/preauthorization.
  6. Do you accept credit card billing or direct patient payment?
    1. The IIHG accepts institutional billing, Visa and MasterCard.
  7. Can I get my patient's results faster than the published turnaround time?
    1. Currently there is no preferential treatment of any samples. 
  8. How are results returned to me?
    1. Results will be returned to the ordering physician and genetic counselor by fax or secure email. 
  9. What is reported?
    1. Variants known to be pathogenic in a gene which may be responsible for the patient's symptoms as reported by the ordering physician.
    2. The IIHG Clinical Diagnostics laboratory utilizes the ACMG Recommendations for standards for interpretation of sequence variations (Richards et al. Genetics in Medicine (2015) 17: 405–42).
  10. Will the report contain medical advice?
    1. No, the report does not contain medical advice, as the ordering physician will need to interpret the test results within the clinical context.
  11. What if extended family members want to be tested? 
    1. If a causative variant is identified by the IIHG, extended family members can be tested for the same variant for a charge. Familial segregation analysis information can be ordered using the PDF icon KidneySeq_v5_Requisition.pdf. The cost and turnaround time of familial testing is determined by the methodology of testing required. Contact the IIHG at iihg-clinicaldivision@healthcare.uiowa.edu or 319-335-3688 for a quote.
  12. Why order a panel? Why not just order the gene(s) that I want tested?
    1. Many diseases have similar phenotypes and testing multiple genes associated with those conditions  can increase the probability of identifying disease-causing variants. Currently, approximately 25% of the genetic testing results reported by the IIHG involving pathogenic variants have indicated a different disease than the indication for testing.
    2. Panels also eliminate the need for another sample acquisition and re-sequencing if future analysis is required. This can save time and money.
  13. Why does the IIHG need information such as race, ethnicity, and a working clinical diagnosis?
    1. The more information provided, the more confident the IIHG can be when reviewing identified variants and returning results. Phenotype-genotype correlation is important for accurate evaluation of your patient’s genetic testing results.