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HIGH DIAGNOSTIC ACCURACY
PREVENTION OF UNNECESSARY SURGERIES
PERSONALIZED MANAGEMENT OF CANCEROUS NODULES
FLEXIBILITY IN SAMPLE TYPES

HIGH DIAGNOSTIC ACCURACY

ThyroSeq® is the most accurate test
for thyroid nodules and cancer

 

  • Comprehensive genomic profiling of thyroid nodules using next-generation DNA and RNA sequencing
  • Clinically validated in the largest prospective, double-blind, multicenter study reported in JAMA Oncology1 and supported by multiple independent studies2-8
  • Highest NPV and PPV among well-validated tests 1
  • Reliable diagnosis of all types of thyroid nodules, including Hürthle cell nodules, medullary thyroid carcinoma, parathyroid, or other non-thyroidal lesions in a single workflow

 

Has already helped inform clinical management for > 70,000 patients9

94%

Sensitivity

82%

Specificity

97%

NPV

66%

PPV

Test performance according to the largest multicenter clinical validation study, reported in JAMA Oncology

PREVENTION OF UNNECESSARY SURGERIES

High reduction of diagnostic surgeries
in nodules with indeterminate cytology

In multicenter study1
61%

 

With very low (3%) residual cancer risk in ThyroSeq-negative nodules, surgery can be avoided in patients with Bethesda III-IV cytology nodules based on NCCN and ATA guidelines

In real-world independent studies2-7
67%

 

  • University of California Los Angeles, CA2
  • Duke University, NC3
  • Boston Medical Center, MA4
  • McGill University, Quebec, Canada5
  • New York University, NY 6
  • University of Pennsylvania, PA7

PERSONALIZED MANAGEMENT OF CANCEROUS NODULES

​​​​​​ThyroSeq® uniquely reports the probability of cancer
and a prediction of cancer recurrence,
informing personalized patient management

Prediction of cancer recurrence is based on:

  • Comprehensive genomic profiling of DNA and RNA to detect four main classes of molecular alterations 1,10

  • Inclusion of all markers of aggressive thyroid cancer (TERT, TP53, AKT1, PIK3CA, and others) 1,10
  • Unique and proprietary database of >3,000 thyroid nodules with known surgical outcome9

Specific management recommendations included in each ThyroSeq® report:

  • Patients with a low-risk for recurrence profile detected by ThyroSeq® may be candidates for limited thyroid surgery (lobectomy)

  • Patients with a high-risk for recurrence profile may be candidates for total thyroidectomy and radioactive iodine treatment

  •  Patients with advanced thyroid cancer may benefit from ThyroSeq® detection of therapeutic targets (BRAF, NTRK, RET, ALK) linked to FDA approved drugs and clinical trials 

Bethesda III-IV Cytology Graphic

 

Abbreviations: MTC, medullary thyroid cancer; PT, parathyroid; Non-TFCL, non-thyroid follicular cell lesion; GEA, gene expression alterations; CNA, copy number alterations; LND, lymph node dissection.

FLEXIBILITY IN SAMPLE TYPES

ThyroSeq® testing has been validated for use
on a variety of specimen types:

Flexibility Section Total Graphic

 

High success rate of testing: 97-100% for fresh FNA samples,
81% for smears (PAP, Diff-Quik) 3-5, 10-12

 

References:

1.Steward DL, et al. JAMA Oncol. 2018. 2.Chin PD, et al. Endocrin Pathol. 2020. 3.Jug R, et al. Cancer Cytopathol. 2020. 4.Guan H, et al. Thyroid. 2020. 5.Chen T, et al. Thyroid. 2020. 6.Schatz-Siemers N, et al. Diagn Cytopathol. 2019. 7.Desai D, et al. Cancer Cytopathol. 2020. 8.Zhu CY, et al. Thyroid. 2020. 9.UPMC, data on file. 10.Nikiforova MN, et al. Cancer. 2018. 11.Carty SE, et al. Ann Surg. 2020 12.Nikiforova MN, et al. Cancer Cytopathol. 2020.

ThyroSeq Molecular Tumor Board

 

 

THYROSEQ® EDUCATIONAL RESOURCES

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Molecular Profiling of 50 734 Bethesda III-VI Thyroid Nodules by ThyroSeq v3: Implications for Personalized Management

Comprehensive genomic analysis of thyroid nodules for multiple classes of molecular alterations detected in a large series of fine needle aspiration (FNA) samples has not been reported.

Read full article

 

Thyroid Cytology Smear Slides: An Untapped Resource for ThyroSeq® Testing

Molecular testing of thyroid nodules with indeterminate fine-needle aspiration (FNA) cytology is commonly used to guide patient management and is typically performed on freshly collected FNA samples. In this study, the authors evaluated the performance of the ThyroSeq® test in cytology smear slides.

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Performance of a Multigene Genomic Classifier in Thyroid Nodules With Indeterminate Cytology: A Prospective Blinded Multicenter Study

In this prospective, blinded, multicenter study, ThyroSeq® GC demonstrated a high sensitivity/NPV and reasonably high specificity/PPV, which may obviate diagnostic surgery in up to 61% of patients with Bethesda III-IV indeterminate nodules, and up to 82% of all benign nodules with indeterminate cytology. Information on specific genetic alterations obtained from FNA may help inform individualized treatment of patients with a positive test result.

Read full article

Learn about ThyroSeq®

Dr. Steven P. Hodak, Professor of Medicine and Endocrinology at NYU School of Medicine and Director of Endocrinology, NYU Langone Medical Center, Tisch Hospital, discusses the use of ThyroSeq® test for thyroid nodules with indeterminate cytology.

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