The Sample Collection Kit includes barcoded collection tubes, a Test Requisition form, an Informed Patient Consent form, and a prepaid shipping envelope. All forms are barcoded to match the collection tubes, so be sure to use the forms in the kit. All forms must be completed and returned for sample processing.
Blood: 4–8 ml of freshly collected blood in a PAXgene DNA tube (provided in the Sample Collection Kit), or a purple top EDTA tube
Contact the laboratory if there are any concerns or questions regarding sample collection and submission.
We require 100% prepayment to begin testing. We do not bill insurance companies. We directly bill the patient or hospital who may then choose to seek reimbursement from insurers. Complete the billing information section on the test requisition, as appropriate.
For questions about the Illumina Clinical Services Laboratory, contact us at (858) 202-4500.
For questions about the Verifi Prenatal Test, contact firstname.lastname@example.org.
Patient privacy and confidentiality are taken seriously at Illumina. Each sample is labeled with a random ID number for laboratory tracking purposes. All Illumina staff that may come into contact with clinical samples and information must complete training consistent with industry standards.
Results are returned via an encrypted hard drive directly to the ordering physician. We encourage doctors and patients to discuss how results from the TruGenome Clinical Sequencing Service will be stored and whether they will be included in the patient's medical records.
Patient information is kept confidential in compliance with all laws. Learn more:
TruGenome Clinical Sequencing Services is performed in the Illumina CLIA (Clinical Laboratory Improvements Amendment)-certified and CAP (College of American Pathologists)-accredited Clinical Services Laboratory. The TruGenome Sequence information is generated by licensed personnel using an analytically validated process. Consistent with Laboratory Developed Tests, it has not been cleared or approved by the U.S. Food and Drug Administration.
This genome sequence information can be analyzed to potentially aid physicians in the evaluation of a broad range of health conditions or physiological traits. Patients will not receive medical results, or a diagnosis, or a recommendation for treatment from Illumina. Any results arising from the analysis of genome sequence information that might be deemed medically actionable should be confirmed using alternative testing. If any questions or concerns arise about what is learned through the genome sequence information, patients should contact their physician or a genetic counselor. Currently Illumina does not accept orders for TruGenome Clinical Sequencing Services from New York.