Author: Admin

CC-SIGN® Targeted Oncology Panel (TOP) by Next-Generation Sequencing

Clinical Updates

New Test: CC-SIGN® Targeted Oncology Panel (TOP) by Next-Generation Sequencing

Available to order starting on June 20, 2023.

A new, enhanced 59-gene hotspot Next-Generation Sequencing (NGS) panel is available for tumor DNA and RNA evaluation.

The Targeted Oncology Panel (TOP) is a custom 59-gene Next-Generation Sequencing (NGS) panel developed for the identification of single nucleotide variants (SNVs), small insertions and deletions (indels), and copy number gains (CNVs) from DNA specimens, and fusion transcripts and aberrant transcripts from RNA specimens.

The workflow allows for the concurrent testing of DNA and RNA to analyze over 1,000 biomarkers.

Read the Technical Brief

Targeted Oncology Panel by NGS

Order Codes
TOPTO (FFPE Tissue)
TOPCY (Cytology Alcohol or Formalin fixed cell block)
TOPBM (Bone Marrow Aspirate)
TOPPB (Peripheral Blood)

This test requires 5-10% tumor purity and does not evaluate circulating tumor DNA.

CPT Code
81445

Methodology
Next-Generation Sequencing

Specimen Type
FFPE Tissue
• 15 charged, unbaked, and unstained slides sectioned at 7 μm.
• One pre and one post H&E slide with tumor area circled, and percent rumor indicated.

Cytology
• 15 charged, unbaked and unstained slides sectioned at 7 μm.
• One H&E slide with tumor percent indicated.

Bone Marrow Aspirate
• 2 mL, Lavender K2EDTA Tube

Peripheral Blood
• 4 mL, Lavender K2EDTA Tube

Days Performed
2–3 times per week

Turnaround Time
8 days

Overview

Single nucleotide variants (SNVs), small insertions and deletions (indels), copy number gains, select fusions, and aberrant transcripts evaluated by this assay can aid in the diagnostic and therapeutic assessment of a variety of tumor types, including non-small cell lung cancer, melanoma, colorectal cancer, prostate cancer, breast cancer, glioblastoma, thyroid cancer, and others.

This panel can also provide focused tumor profiling for patients with locally advanced/metastatic disease, who are candidates for anti-cancer therapy, to identify uncommon but targetable alterations. In particular, this panel can be utilized for small biopsies and cytology specimens that may not be amenable to more comprehensive genomic sequencing.

Targeted Genes & RNA Fusions

For a full list of targeted genes & RNA fusions, please refer to the Targeted Oncology Panel by Next-Generation Sequencing Technical Brief.

How to Order

Place an order through an electronic interface or complete a Molecular Oncology & Associated Biomarkers Requisition and submit it with the specimen(s).

Hot Spot Panel Discontinuation

The TOP NGS panel will replace solid tumor hotspot mini-panels (Lung, Colorectal, Melanoma, GIST, etc.), as all previously detected biomarkers are included in the new testing.

In situations where the mini-panels were previously used as part of an upfront diagnostic workup, pathologist diagnostic and reflex ordering will utilize TOP testing.

Special Communications
Immediate Test Changes
News & Updates

May 2023: Discontinued – Natural Killer Cells, Functional (NKFUNC)

Immediate Test Change

Test Discontinuation – Natural Killer Cells, Functional (NKFUNC)

Effective May 22, 2023.

Natural Killer Cells, Functional (NKFUNC) testing has been discontinued.

Discontinuation is due to limited availability, logistical limitations, and short specimen stability (less than 23 hours).

Please do not order Natural Killer Cells, Functional (NKFUNC) testing. If you have an urgent need for testing, please get in touch with Client Services.

Special Communications
Immediate Test Changes
News & Updates

May 2023: New Test – Clozapine (CLOZA)

Clinical Updates

New Test: Clozapine (CLOZA)

Effective May 23, 2023.

Therapeutic drug monitoring for clozapine will be offered as an in-house test starting Tuesday, May 23, 2023.

The current send-out test, Clozapine and Metabolites, Serum or Plasma, Quantitative (CLOZSP), currently sent out to ARUP Laboratories, will be discontinued on June 20, 2023.

Clozapine (CLOZA)

New Test – CLOZA

Specimen Type
Red Serum Tube (No Additive)

Methodology
Turbidimetric immunoassay

Result Components
Clozapine

Days Performed
Monday – Saturday

Turnaround Time
1-4 days

Clozapine results greater than 1000 ng/mL have been designated as urgent.

Sendout Test – CLOZSP

Specimen Type
Red Serum Tube (No Additive) or Lavender K2EDTA Tube

Methodology
Liquid chromatography-tandem mass spectrometry

Result Components
Clozapine
Norclozapine
Clozapine-N-Oxide

Days Performed
Sunday – Saturday

Turnaround Time
2-4 days

Special Communications
Immediate Test Changes
News & Updates

May 2023: COVID-19 Testing – CPT Code Update

Immediate Test Change

COVID-19 Testing – CPT Code Update

Effective May 11, 2023.

In accordance with recent guidance provided by the Department of Health and Human Services on May 9, 2023, the CPT code associated with COVID-19 testing will change.

Beginning May 11, 2023, the CPT code is changing as a result of the end of the COVID-19 Public Health Emergency.

The new CPT code will display in the Test Directory starting May 11, 2023.

COVID-19 Testing

New CPT Code
87635 (previous: U0003)

Additional Information
For more information, please refer to HHS’s Fact Sheet: End of the COVID-19 Public Health Emergency.

Special Communications
Immediate Test Changes
News & Updates

May 2023: Changes to Legionella Diagnostic Testing (LEGPCR)

Clinical Updates

Changes to Legionella Diagnostic Testing (LEGPCR)

Effective May 2, 2023.

Improvements to Cleveland Clinic Laboratories’ Legionella PCR assay will result in the discontinuation of most Legionella cultures.

Beginning May 2, 2023, Legionella pneumophila PCR (LEGPCR) will include additional DNA targets for Legionella, including species other than Legionella pneumophila, and a target specific for Legionella pneumophila serogroup 1.

This assay design is modeled after the U.S. Centers for Disease Control & Prevention’s assay.1

Legionella pneumophila PCR (LEGPCR)

Specimen Requirements
Lower respiratory samples, including bronchoalveolar lavage (BAL) and sputa, will continue to be the acceptable specimen types for PCR.

Results
Possible interpretations of test results include:

  • Legionella pneumophila Serogroup 1 Detected
  • Legionella pneumophila (not Serogroup 1) Detected
  • Legionella species (not pneumophila) Detected

Additional Updates
Beginning May 23, 2023, routine culture for Legionella spp. (LEGCUL) will be discontinued, but culture will reflexively be performed on any sample with detectable Legionella DNA by PCR.

Note: There is no change to Legionella urine antigen (LEGUAG) testing.

Reference

1 Benitez AJ, Winchell JM. Clinical application of a multiplex real-time PCR assay for simultaneous detection of Legionella species, Legionella pneumophila, and Legionella pneumophila serogroup 1. J Clin Microbiol. 2013 Jan;51(1):348-51. doi: 10.1128/JCM.02510-12. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3536254/pdf/zjm348.pdf

Special Communications
Immediate Test Changes
News & Updates

April 2023: Updates to H. pylori Urea Breath Test

Immediate Test Change

Updates to H. pylori Urea Breath Test (HPYLBR)

Effective May 2, 2023.

Updated Test

Helicobacter pylori Breath Test (HPYLBR)

Effective May 2, 2023, the Immunopathology Laboratory section of Cleveland Clinic Laboratories will provide a new H. pylori urea breath test.

The qualitative test, based on infrared spectroscopy using 13C, is an aid in diagnosing active infection with Helicobacter pylori and post-treatment monitoring in adult and pediatric patients ages 3-17 years old.

Changes to Specimen Collection

Specimens must be collected with the Meridian Bioscience collection kit; otherwise, testing will be canceled.

Collection Kits

The BreathID® Hp® Two test requires specimen collection with the BreathID® IDkit Hp® Two kit.

One box contains five kits. Each kit contains:

  • (1) Blue baseline breath collection bag
  • (1) Grey post-ingestion breath collection bag
  • 75mg 13C-urea tablet
  • 4.3g package of Citrica (citric acid)
  • Straw
  • Drinking cup
  • User guide
  • (4) Labels
  • Sample transport bag
  • Package insert

Order BreathTek® Urea Breath Test Kits
Collection Instructions

Test Overview

Test Name

Helicobacter pylori Breath Test

Test Code

HPYLBR

CPT Code

83013

Methodology

13C Infrared Spectroscopy

Specimen Type

1 baseline (blue) and 1 post-dose (gray) breath sample bag collected with a BreathID® IDkit Hp® One kit

Stability

Ambient
14 days

Refrigerated
Unacceptable

Frozen
Unacceptable

Reference Range

Negative

Clinical Information

The Urea Breath Test is used as an aid in the diagnosis of current infection with Helicobacter pylori.

Limitations

Despite very high specificity, false positive results may occur due to other gastric organisms, such as H. heilmanni, as well as in patients with hypo- or achlorhydria.

False-negative results may occur in patients who have received antibiotics, proton pump inhibitors, or bismuth preparations.

Clinical correlation is required.

Special Communications
Immediate Test Changes
News & Updates

2024 Cleveland Clinic Multispecialty Pathology Symposium – Register Now!

Clinical Updates

2024 Cleveland Clinic Multispecialty Pathology Symposium

January 26-28, 2024  |  Wynn Las Vegas

Overview

This pathology symposium will focus on practical discussions of commonly encountered problems in surgical pathology. The goal is to provide useful tips that the speakers utilize in their own practice at the microscope. We aim to address and discuss common problems and avoid an undue focus on esoterica.

In this course, renowned subspecialists who are highly sought-after for their teaching skills will cover a broad spectrum of cases, including genitourinary pathology, thoracic pathology, gastrointestinal and soft tissue pathology, gynecologic cancer, and breast pathology.

Practicing pathologists, fellows, and residents who attend will maintain, develop, and increase their knowledge, competence, and professional performance, with the intent to improve diagnosis and positively impact patient care.

Target Audience: Pathologists, Pathology Residents & Fellows

This activity has been approved for AMA PRA Category 1 credit™.

Register Now!

Symposium Co-Directors

Sanjay Mukhopadhyay, MD

Sean Williamson, MD

Sean Williamson, MD

Faculty Presenters

John Goldblum, MD

John Goldblum, MD

Amy Joehlin-Price, MD

Amy Joehlin-Price, MD

Andrew Sciallis, MD

Andrew Sciallis, MD

Agenda

Friday

Friday, January 26, 2024

7:00 am           Registration, Continental Breakfast, and Exhibits

8:00 am           Welcoming Remarks – Sean Williamson, MD, and Sanjay Mukhopadhyay, MD

 

Genitourinary Pathology

8:10 am           Pattern Based Approach to Renal Cell Tumors – Sean Williamson, MD

9:00 am           What’s New in Prostate Cancer Pathology? – Sean Williamson, MD

9:45 am           Question & Answer Period

10:00 am         Refreshment Break and Exhibits

 

GI and Soft Tissue Pathology

10:30 am         Barrett’s Esophagus and BE-related Dysplasia: A Practical Approach to the Most Common Problems – John Goldblum, MD

11:15 am         IBD and IBD-related Dysplasia with a Focus on Unusual Variants of Ulcerative Colitis – John Goldblum, MD

12:00 pm         Question & Answer Period

 

12:15 pm         Lunch served at Wynn Las Vegas

 

Pulmonary Pathology

1:15 pm           The New, the Exciting, and the Annoying. Updates in Lung Cancer in 2023 – Sanjay Mukhopadhyay, MD

2:00 pm           What I Learned from Mistakes in Thoracic Pathology – Sanjay Mukhopadhyay, MD

2:45 pm           Questions & Answer Period

3:00 pm           Refreshment Break and Exhibits

 

Gynecologic Pathology

3:30 pm           Practical Staging in Endometrial Cancer: Important Details Made Easier – Amy Joehlin-Price, MD

4:15 pm           Classifying High Grade Endometrial Cancer: When Histotype Matters and Why – Amy Joehlin-Price, MD

5:00 pm           Question & Answer Period

 

5:15 pm           Adjourn

Saturday

Saturday, January 27, 2024

7:15 am           Continental Breakfast and Exhibits

 

Breast Pathology

8:00 am           Problematic Intraductal Breast Lesions – Andrew Sciallis, MD

8:45 am           Papillary Neoplasms of the Breast – Andrew Sciallis, MD

9:30 am           Question & Answer Period

 

9:45 am           Refreshment Break and Exhibits

 

Pulmonary Pathology

10:15 am         10 Lung Tumors You Must Have in Your Toolbox – Sanjay Mukhopadhyay, MD

11:00 am         Mesothelioma and Thymoma: Tips and Tricks to Simplify Your Life – Sanjay Mukhopadhyay, MD

11:45 am         Question & Answer Period

 

12:00 pm         Lunch – On Your Own

 

GI and Soft Tissue Pathology

1:30 pm           Common Problems in Diagnosis and Terminology in Colorectal Polyps – John Goldblum, MD

2:15 pm           The Trouble with Fat: How to Handle the Most Common Lipomatous Tumors – John Goldblum, MD

3:00 pm           Question & Answer Period

 

3:15 pm           Refreshment Break and Exhibits

 

Genitourinary Pathology

3:45 pm           What’s New in Bladder Cancer Pathology? – Sean Williamson, MD

4:30 pm           Common Challenges in Testicular Tumors – Sean Williamson, MD

5:15 pm           Question & Answer Period

 

5:30 pm           Adjourn

Sunday

Sunday, January 28, 2024

7:15 am           Continental Breakfast and Exhibits

 

Gynecologic Pathology

8:00 am           Ovarian Frozen Section Pathology: How What You Say Affects What They Do – Amy Joehlin-Price, MD

8:45 am           Vulvar Squamous Cell Carcinoma: Why We’re Making It More Complicated and How to Think about It Simply – Amy Joehlin-Price, MD

9:30 am           Question & Answer Period

 

9:45 am           Refreshment Break and Exhibits

 

Breast Pathology

10:15 am         Challenging Spindle Cell Lesions of the Breast – Andrew Sciallis, MD

11:00 am         Fibroepithelial Lesions of the Breast: An Overview – Andrew Sciallis, MD

11:45 am         Question & Answer Period

 

12:00 pm         Closing Remarks – Sean Williamson, MD, and Sanjay Mukhopadhyay, MD

 

12:15 pm         Adjourn

Special Communications
Immediate Test Changes
News & Updates

December 2022: Changes to Acceptable Tube Type for Azole Anti-Fungal Therapeutic Drug Monitoring

Special Communication

December 2022: Changes to Acceptable Specimen Containers for Azole Anti-Fungal Therapeutic Drug Monitoring

Effective December 20, 2022

Plasma collected in Green Lithium Heparin Tubes will no longer be accepted for azole anti-fungal therapeutic drug monitoring tests.

Please collect samples for Azole Anti-Fungal Therapeutic Drug Monitoring tests in Red (serum) No Additive Tubes, centrifuge, and transfer the serum to an aliquot tube.

Tests Affected:

  • Fluconazole (FLUC)
  • Isavuconazole (ISACON)
  • Itraconazole (ITRAC)
  • Posaconazole (POSACN)
  • Voriconazole (VORCON)

Updated Specimen Requirements

Specimen Type:
Serum

Volume:
0.5 mL

Collection Container:
Red (Serum) No Additive Tube

Transport Temperature:
Refrigerated

Do not use gel separator tubes.

Special Communications
Immediate Test Changes
News & Updates

Pathology Insights: Tumors of the Lung with Sanjay Mukhopadhyay, MD

Pathology Insights Video Series

Tumors of the Lung

Presented by Sanjay Mukhopadhyay, MD

In this video, an expert pulmonary pathologist and director of Cleveland Clinic’s Pulmonary Pathology service briefly covers all lung tumor types – including all the subtypes of lung cancer – listed in the new (2021) World Health Organization classification. Dr. Mukhopadhyay then describes the primary pathologic features of these tumors with high-quality pathology images provided in most cases.

This video should be helpful for patients, surgeons, pulmonologists, oncologists, pathologists, residents, and medical students.

As part of our educational mission for our clients and communities, Cleveland Clinic Laboratories presents the Pathology Insights video series.
These short videos break down information about interesting pathology cases to better inform doctors, laboratory staff, patients, or anyone interested in the field of pathology. Each episode features important cases, methods, and practices that are personally presented by our staff pathologists.