New Test

Neo Comprehensive™ – Heme Cancers

Precise profiling. Expert analysis. Complete results.

NeoGenomics is proud to announce a new NGS-only assay for the assessment of heme cancers. Neo Comprehensive™ – Heme Cancers is now available!

Neo Comprehensive – Heme Cancers is a DNA & RNA next-generation sequencing (NGS) comprehensive genomic profile (CGP) that analyzes 433 genes relevant in heme cancers for diagnostic evaluation, prognosis, risk stratification, and therapy guidance.

• 302 genes by DNA sequencing
• 302 genes for SNVs/InDels
• 23 genes for copy number variants (CNVs)
• 184 genes by RNA sequencing
• both known and novel fusions

Neo Comprehensive – Heme Cancers is the largest and most comprehensive NGS panel for heme cancer assessment at NeoGenomics. It is aligned with the latest guidelines, including the WHO 5th Edition Classification, covering both myeloid and lymphoid neoplasms.

Some basic test details include:

• Specimen Requirements: bone marrow (2-3 mL), peripheral blood (3-5 mL), or FFPE tissue (paraffin block)
• Turnaround Time (TAT): 14 days
• CPT Code*: 81455 (MolDx CPT Code: 81479)
• NYS Approval? Yes

Note: FLT3 by PCR (via FLT3 Mutation Analysis) is available as an optional add-on, by Client-Bill only, for faster FLT3 results (5-day TAT) for the purpose of prompt therapy selection.

Important! The Neo Comprehensive – Heme Cancers assay will immediately replace the NeoTYPE^® Discovery Profile for Hematologic Cancers (aka NeoTYPE Discovery Heme).

• Orders of the NeoTYPE profile will be automatically converted to the new Neo Comprehensive assay.
• Pricing will remain the same.

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

*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.

Test Updates

Effective Monday, October 2nd, we will be upgrading our existing Halo AI Image Analysis Software for breast cancer markers and MMR panel.

• Validation of the HER2 membrane algorithm using Roche’s updated HER2 protocol, a nuclear breast algorithm for ER, PR and AR, a nuclear breast algorithm with nuclear segmenter for Ki67, as well as an additional algorithm for our MMR panel.
• This upgrade will also include the ability to perform analysis using 40X images, enhancements in Virtual Microscope viewer, and changes to the tumor detection filter.
• Each algorithm has been validated in accordance with CAP guidelines for validating Whole slide Imaging and for Quantitative Image Analysis of HER2 IHC for Breast Cancer. Inter-laboratory and inter-observer concordance were shown for IHC staining and Image analysis performed at NeoGenomics laboratories in Aliso Viejo, CA, Houston, TX and Fort Myers, FL.

Update: An updated Image Analysis User Guide and recorded training are now available! Please review the training in NeoUniversity™ here. The Image Analysis User Guide is located along with the NeoUniveristy™ training as well as in NeoLINK under the ‘Documentation’ section. For any immediate questions, please contact your local Sales Consultant or Client Services at 1-866-776-5907, option 3.

Requisition Updates

New versions of all Heme requisition forms are now available for download on Neo website and for orders with Client Services team.

• Hematopathology Requisition – version 081023
• Oncology Office Hematology Requisition – version 081023
• New York State Hematopathology Requisition – version 080923
• New York State Oncology Office Hematology Requisition – version 081623

Test Discontinuations

The below molecular tests are now discontinued. Replacement options have been listed, if available, for your reference.

IHC/FISH

HER2 Colorectal IHC and FISH testing is now discontinued. This discontinuation was due to a lack of consensus scoring for HER2 in colorectal carcinoma using the HERACLES trial and no scoring recommendation yet published by CAP/ASCO.

• Clients that want to test HER2 on Colorectal samples should now order HER2 (Other) with Gastric Scoring for IHC or FISH.
• The NeoTYPE^® Colorectal Tumor Profile and NeoTYPE^® GI Predictive Profile, both of which contained HER2 Colorectal testing, now have HER2 (Other) with Gastric Scoring testing as the replacement.
• Important: This update is available in Online Orders and Interfaced Orders. Test Requisitions will trail in being updated until the next revision is available with an approximate October timeframe. As a result, HER2 Colorectal orders that come in on test requisitions will automatically be converted to HER2 (Other) with Gastric Scoring.

Additional Announcements

Interface and online ordering clients now have the ability to easily order Neo Comprehensive^™ – Solid Tumor as a reflex option for their CancerTYPE^® ID test.

When CancerTYPE ID^® and NeoTYPE^® Cancer Profiles are ordered together, the NeoTYPE® profile performed will be based on the CancerTYPE ID® result as shown on the CTID ordering page. If Neo Comprehensive – Solid Tumor is the preferred and ordered test, Neo Comprehensive – Solid Tumor will be performed instead of a NeoTYPE^® profile (for non-New York). In addition, PD-L1 by IHC can be added-on to any NeoTYPE profile (if not already included in profile) or Neo Comprehensive – Solid Tumor. This expanded offering affords the opportunity for DNA and RNA analysis to be performed for any sample through the Neo Comprehensive – Solid Tumor panel of 517 genes plus TMB and MSI analysis.

Interface Updates

For a complete list of interface-related test changes that occurred on Monday September 11, click here for a downloadable document to view the impacted interface test codes.