October 23, 2024

Special Announcement

Now Available!  Claudin 18 FDA IHC

Claudin18.2 (CLDN18.2) has emerged as a key biomarker in gastric and gastroesophageal junction (GEJ) cancers, helping to identify patients who may benefit from targeted therapies. Its specificity to gastric tissues enables more precise and effective treatments, ultimately improving patient outcomes.

Approximately 70% of advanced G/GEJ cancers express CLDN18.2 at any amount. Of advanced G/GEJ cancers that express CLDN18.2, 38% express moderate to high levels that indicate eligibility for targeted therapy.¹

NeoGenomics is pleased to be one of the first labs to offer Claudin18 FDA (VYLOY®) for Gastric/GEJ Adenocarcinoma testing with a fast 48-hour TAT to maximize patient treatment outcomes.

Basic test details:

• Level of Service: Global and Tech-Only
• CPT Code*: 88360x1
• TAT: Global: 48 hours, Tech-Only: 24 hours
• NYS Approved: Yes

 

We are excited to announce that New York State clients can now order both Neo Comprehensive™ – Solid Tumor and NeoTYPE® DNA & RNA – Lung!

Don’t miss anything actionable with Neo Comprehensive – Solid Tumor, NeoGenomics’ largest pan-cancer comprehensive genomic profile, with 517 genes, MSI, and TMB by DNA & RNA next-generation sequencing. Neo Comprehensive – Solid Tumor helps you optimize your testing strategy by covering all clinically relevant genes, including both diagnostic and prognostic markers and markers that influence participation in clinical trials.

NeoTYPE DNA & RNA – Lung provides the predictive and prognostic answers you need quickly, with targeted biomarker analysis via Next-Generation Sequencing specific to lung disease. Our fast, targeted, tissue-based assay covers 50 clinically relevant 50 genes, MSI, and TMB by DNA & RNA NGS.

Both tests offer an 8-10 day turnaround time. Additional time (beyond published TAT) may be needed for New York state clients where findings require fusion confirmation testing per regulatory guidelines. PD-L1 is available as an add-on for both assays.

If you are an interface client, please formally request these test codes.

 

New Test

NEO | AML Express™

One order. One specimen. Rapid, informed decisions.

NeoGenomics is proud to announce a new NGS-only assay for the assessment of acute myeloid leukemia (AML). NEO | AML Express provides class-leading turnaround time of 3-4 days, delivers a single report that offers a comprehensive NGS-based assessment, and aids in diagnosis, prognosis and therapy selection.

NEO | AML Express is a DNA & RNA next-generation sequencing (NGS) assay that is aligned with the latest guidelines, including the WHO 5th Edition Classification, for AML.

• 38 genes by DNA sequencing for SNVs/InDels
• 9 genes by RNA sequencing for fusions

Test details:

• Specimen Requirements: bone marrow (1-2 mL) or peripheral blood (2-3 mL) in EDTA
• Turnaround Time (TAT): 3-5 days
• Billing: Client-Bill only
• NYS Approval: No

IMPORTANT! To ensure fast TAT and specimen stability, please ship all orders directly to Neo Houston lab.

For more info, please contact your local NeoGenomics Territory Business Manager or visit the test menu page here.

 

Test Updates

Molecular

NRAS Mutation Analysis

Effective Monday, October 28th, NRAS Mutation Analysis will be performed by real-time PCR instead of bi-directional Sanger sequencing. Shifting from Sanger to PCR will increase test sensitivity and create operational workflow efficiencies, allowing for continued focus on improving patient care. The following changes will be implemented for this test:

 

New Test	NRAS Mutation Analysis by PCR
Old (Discontinued) Test	NRAS Mutation Analysis

• Test Name Change to: NRAS Mutation Analysis by PCR
• Test Information: This test is a real-time PCR-based assay designed to detect somatic mutations in exons 2, 3 and 4 of the NRAS gene. Please note that the scoring of this test will indicate whether any pathogenic NRAS mutation was present, “Detected” or “Not Detected”, but the specific NRAS mutation will not be reported.
• CPT Code: 81311 (this test will no longer utilize 81403 in addition to 81311)
• No changes: to Specimen Requirements, CPT codes or TAT (7 days)
• Ordering: Online Orders will be updated with the new test name on the effective date. There is no change to the ordering name on test requisitions
• New York State Clients: This test is actively undergoing submission for NYS approval. NYS Clients will continue to be able to order the Sanger-based test until the new PCR test is approved. Stay tuned to NeoNEWS for continued updates on availability
• Interfaced clients: Please refer to the interface section of NeoNEWS for additional details

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.

 

FISH

As of Monday, October 21st, the FISH Signal Guide has been updated with the following changes.

• Addition of EGFR scoring criteria for brain cancer
• Update of cut-offs for IGK/MYC t(2;8) Translocation (xR>2G) and IGL/MYC t(8;22) Translocation (xR1G) on Peripheral Blood, Bone Marrow, and fresh tissue samples

The updated FISH Signal Guide is now available for download on NeoLINK under Documentation.

 

Test Discontinuations

 

Effective Monday, November 4th, the tests listed below will be discontinued from our menu in an effort to streamline our offerings so that you have access to the most up-to-date solutions available while still maintaining our exceptional quality and service. Alternative test options, where available, have been listed for your reference. Please visit our website for our complete directory of tests.

We thank you for your continued trust in our service to support your patient care.

 

Test to be Discontinued	Modality	Alternative Test Option(s)
ALK Mutation Analysis	Molecular	NeoTYPE® DNA & RNA-Lung, Neo Comprehensive™ - Solid Tumor, NeoTYPE® Lung Tumor Profile, NeoTYPE® Discovery (NY Clients)
PIK3CA LDT Mutation Analysis by Sequencing	Molecular	NeoTYPE® Breast Tumor Profile, Neo Comprehensive - Solid Tumor
Calcium Stain	AP	None
CDX2/CK7 Double Stain	AP	CDX2 and CK7 singular stains
CK 14	AP	None
CK 18	AP	None
CK HMW/LMW Double Stain	AP	None
CMV (ISH)	AP	CMV IHC
Collagen IV	AP	None
ERCC1	AP	None
Fascin	AP	Combination of PAX5/CD30 IHC or EBV LMP
Pneumocystis Carinii (Jiroveci)	AP	None
Smoothelin	AP	Desmin IHC
Thymidylate Synthase	AP	None
RRM1	AP	None
pAKT	AP	None