This is a pre-solicitation notice. A solicitation for this requirement will be posted soon. Title: Endocrinology Testing 1. INTRODUCTION AND OVERVIEW: Fine Needle Aspiration (FNA) cytology is a common approach to evaluate thyroid nodules. It offers definitive diagnosis of a benign or malignant nodule in the majority of the cases. However 10-25% of nodules yield one of three indeterminate cytological diagnoses leading to suboptimal management of these patients. Atypia of undetermined significance/follicular lesion of undetermined significance (AUS/FLUS) are a common indeterminate diagnosis with cancer risk ranging from 6% to 48%. Current guidelines recommend that most of these patients undergo diagnostic thyroid surgery to assess whether nodules are benign or malignant. Approximately 70% to 80% of the time, the nodules prove to be benign by surgical pathology. The ThyroSeq v.2 multigene Next Generation sequencing (NGS) panel of molecular mutational markers provides both high sensitivity and high specificity for cancer detection in thyroid nodules with AUS/FLUS cytology, which should allow improved management of these patients by avoiding many of the diagnostic surgeries currently performed for benign nodules, with associated decreases in health costs and postsurgical complications. Through ThyroSeq v.2 over 400 hotspots and fusion points on over 60 genes are tested to classify both benign and malignant nodules. By doing a Next Generation Sequencing of gene to determine whether the nodule is benign or malignant ThyroSeq v.2 we comply with VA's mission of providing exceptional care that improves the health and overall well-being of the Veteran. 1.1 Background: The ThyoSeq v.2 FNA Analysis is a diagnostic service provided for the assessment of thyroid nodules. The ThyroSeq v.2 Next Generation sequencing combines specialized cytopathology experts from incumbent vendor who properly identifies and categorizes biopsies allowing for further testing on only truly indeterminate FNAs. Physicians submit to incumbent vendor thyroid nodule FNA samples collected in a single patient visit. The combination of cytopathology screening with reflex to molecular testing is what makes ThyroSeq V.2 the most accurate diagnosis allowing patients to avoid unneeded surgeries and receive the right surgery. 1.2 Scope of Work Northport VAMC estimates approximately 96 tests per year. Patient samples obtained through fine needle aspirate (FNA) biopsies are collected for both cytopathology assessment and ThyroSeq v.2. Initially cytopathology assessment is conducted. If the cytopathology diagnosis is benign, suspicious for malignancy, malignant or non-diagnostic, the Cytopathology FNA Analysis is complete. If the cytopathology diagnosis is indeterminate (includes Follicular lesion of Undetermined Significance (FLUS)/Atypia of Undetermined significance (AUS) and (suspicious for) Hurthle/Follicular Neoplasm), the thyroid nodule is greater than or equal to 1 cm and the patient is 21 or older, The ThyroSeq v.2 Next Generation gene sequencing is performed. Thyroseq v.2 measures gene mutation which classifies both benign and malignant nodules by identifying actual mutations. Over 400 hotspot genes and fusion points on over 60 genes are tested. All results will be reported by the incumbent vendor.

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