miRInform Thyroid

The diagnostic dilemma…

Palpable thyroid nodules occur in 5-7% of the adult population but, the clinical relevance of thyroid nodules rests with the need to exclude thyroid cancer which occurs in 5-15% of them. Fine needle aspiration (FNA) is currently the standard preoperative diagnostic procedure used to evaluate thyroid nodules. The evaluation is performed by a pathologist who looks at cells from the nodule under a microscope to determine if the nodule is benign or malignant. However, in 10-40% of the cases, the cytological diagnosis remains indeterminate, due to overlapping cytological features between benign and malignant nodules⁴.

The majority of the patients who receive an indeterminate FNA diagnosis undergo surgical resection of either all or a portion of their thyroid gland. However, research has shown that up to 85% of these indeterminate nodules are diagnosed as benign upon post-surgical analysis⁴.

The American Thyroid Association (ATA) has created guidelines which seek to provide Physicians with tools that better discriminate between benign and malignant thyroid nodules to improve preoperative diagnostic accuracy¹. The miRInform Thyroid Panel is composed of markers which were given a "C" recommendation by the ATA, meaning the recommendation is based on expert opinion.

These markers are recommended by the ATA (recommendation rating of "C") to improve preoperative cytological diagnostic accuracy for indeterminate thyroid nodules¹. Additionally, these mutations and translocations are found in up to 80% of papillary (BRAF, RAS, RET/PTC) and 70% of follicular (RAS, PAX8/PPARγ) thyroid cancers based on post-operative histological analysis⁵.

How do I order the miRInform Thyroid Panel? To order the miRInform Thyroid Panel, you first need to contact Asuragen to request a miRInform Thyroid Starter Kit. The Kit consists of test requisition forms and sample collection and transportation supplies, all of which are provided at no charge. Once you receive these supplies, you will need to collect an extra FNA biopsy, express it into the provided preservative solution, complete the requisition form and ship these items to Asuragen via the included pre-paid FedEx shipping label.

How do I ship the FNA specimen to Asuragen for miRInform Thyroid testing? Asuragen will provide you with all of the necessary sample collection and shipping materials including preservative vials, biobags, shipping boxes, FedEx clinical packs and pre-paid FedEx shipping labels.

What are the sample requirements for miRInform Thyroid? The miRInform Thyroid Panel requires one dedicated FNA biopsy containing a minimum of 50ng of tissue.

What QA procedures are performed prior to testing to determine the quality of specimens? The quality and quantity of the nucleic acids within extracted FNA specimens are assessed by spectrophotometry. If sufficient sample is available, all attempts will be made to provide test results to the physician. If inadequate sample is present, the physician will be contacted for a replacement sample.

Can I put more than one FNA in the same vial of preservative? FNAs from the same nodule can be expressed into the same vial of preservation solution. However, FNAs from different nodules need to be expressed into separate vials and the location of each nodule should be labeled on the requisition form and on the vial correspondingly.

What is the turnaround time for the miRInform Thyroid Panel? Results for the miRInform Thyroid Panel can be expected within 7-10 days of the day Asuragen receives the sample and completed test requisition form.

How long does the provided solution preserve the FNA specimen for miRInform Thyroid testing? The provided preservative solution keeps FNA specimens good for up to six weeks at ambient temperature.

What is the sensitivity and specificity of the miRInform Thyroid Panel? The clinical validation of miRInform Thyroid is ongoing but the test has been analytically validated. Therefore, neither a clinical sensitivity nor specificity can be given at this time. However, the analytical sensitivity and specificity of the assay is 95% and 99% respectively.

Why were the markers which make up the miRInform Thyroid Panel selected? The markers which make up the miRInform Thyroid Panel were selected based upon numerous clinical studies and publications for their high correlation with thyroid cancer. Additionally, these markers are recommended in the American Thyroid Association guidelines to aid in the diagnosis of patients with indeterminate thyroid nodules.

What does a positive result mean? The miRInform Thyroid Panel has been analytically validated for the detection of the markers contained within the Panel. A positive result is indicative of the fact that at least one of the markers was detected. The clinical validation of the miRInform Thyroid Panel is ongoing and when it is complete, a clinical indication will accompany a positive result.

What does a negative result mean? The miRInform Thyroid Panel has been analytically validated for the detection of the markers contained within the Panel. A negative result is indicative of the fact that none of the markers were detected. It is important to note that a negative result does not mean the nodule is benign.

 

Specimen: FNA biopsy collected in Asuragen’s proprietary nucleic acid preservation solution.

Volume: One FNA pass.

Container: A provided tube containing Asuragen’s proprietary nucleic acid preservation solution.

Special Instructions: Specimens should be labeled with 2 or more patient identifiers that match the test requisition form, such as patient name, DOB and barcode.

Storage & Shipping Instructions: Store at room temperature (15 to 30°C) and ship at ambient temperature using the materials supplied to you by Asuragen.

Causes for Rejection: Asuragen cannot accept specimens for testing if:

a. Test requisition form is missing, incomplete, incorrectly filled, or illegible. Common errors include missing patient information, missing collection date, mismatched specimen identifiers between patient tube and the information provided on the test requisition form, lack of physician’s signature, etc.

b. Improper specimen type is submitted for the test requested.

c. Specimen shipment guidelines were not followed.

d. Specimen vial is leaking or broken.

The following CPT codes will be used when billing for miRInform™ Thyroid: 83913, 83907, 83891, 83902, 83896, 83898, 83909, 83912

Note: Asuragen does not accept Medicaid. Asuragen cannot accept samples from New York or Florida at this time.

For additional billing information, please contact Clinical Laboratory Support: Phone: 888-772-8018 Email: ClinicalLabSupport@asuragen.com

Results can be expected within 8-10 business days from the date the sample is received.