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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 09, 2016 FBO #5251
DOCUMENT

Q -- Cytopathology & Thyrosequence Testing - Attachment

Notice Date

4/7/2016
 

Notice Type

Attachment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Veterans Affairs;James J. Peters VA Medical Center;Network Contracting Office 3 (10N3NCO);130 West Kingsbridge Road;Bronx NY 10468-3904
 

ZIP Code

10468-3904
 

Solicitation Number

VA24316Q0356
 

Response Due

4/28/2016
 

Archive Date

6/27/2016
 

Point of Contact

Delfo R. Saco-mizhquiri
 

Small Business Set-Aside

N/A
 

Description

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. 1.1Background: 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. 1.2Scope 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.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BroVANAP/VAMD/VA24316Q0356/listing.html)
 

Document(s)

Attachment
 

File Name: VA243-16-Q-0356 VA243-16-Q-0356_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2661055&FileName=VA243-16-Q-0356-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2661055&FileName=VA243-16-Q-0356-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Department of Veterans Affairs;Northport VA Medical Center;79 Middleville Road;Northport

Zip Code: 11768
 

Record

SN04076984-W 20160409/160407235056-d186faff6d885afed1f925e09e49c896 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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