New Tests

Now Available
Neo Comprehensive – Solid Tumor & Upgraded NeoTYPE^® DNA & RNA – Lung Assays

NeoGenomics is excited to announce the launch of both Neo Comprehensive – Solid Tumor and the upgraded NeoTYPE^® DNA & RNA – lung assays; a simpler, better, faster approach to genomic profiling for solid tumors.

Product Highlights

• Simpler: Both assays are NGS based (DNA and RNA) with a NEW, simpler-to-interpret report.
• Better:
• Neo Comprehensive – Solid Tumor: Comprehensive Genomic Profile with enhanced clinical coverage and actionability from across 517 pan-cancer genes.
• NeoTYPE^® DNA & RNA – Lung: Targeted profile focusing in on 50 lung-specific genes.
• Both assays provide enhanced detection of:
• SNVs, CNVs, InDels, fusions, and splice variants
• MSI and TMB
• Superior RNA fusion detection
• Reduced input requirements.
• Faster: Results in 10-days*

*Specimens must be shipped directly to NeoGenomics San Diego site for 10-day TAT. Please contact Client Services number 866.776.5907, option 3 for a shipping label that goes directly to San Diego.

**If medically necessary, PD-L1 can be added and will report separately.

Test Updates

IDH1/IDH2 Mutation Analysis by PCR is now available for New York State orders!

• Methodology: the test is performed by real-time PCR for optimal sensitivity. IDH1 and IDH2 will be analyzed concurrently for detection of mutations at IDH1 codons R132X and R100Q and at IDH2 codons R140X and R172X.
• Turnaround time (TAT): 5 days
• CPT Codes*: 81120, 81121 (MolDx CPT Code: 81479)

Flow Cytometry

B-ALL MRD Flow Panel: Effective as of March 13th, this panel is now orderable as either Bone Marrow or Peripheral Blood.

• B-ALL MRD Flow Panel (Bone Marrow) will have additional antibodies to address the issue of hemodilution of bone marrow aspirates, which limits flow cytometric evaluation. The added antibodies will aid in evaluating the extent of hemodilution in bone marrow specimens.
• Panel consists of two tubes:
• Tube #1: same antibodies as the current panel
• Tube #2 for additional antibodies: CD16, CD14, CD13, CD45, and HLA-DR
• CPT Codes* have changed to: 88184x1, 88185x13 (88188x1 for global)
• B-ALL MRD Flow Panel (Peripheral Blood)
• Panel of one tube will have the same antibodies as the current panel.
• CPT Codes* remain the same: 88184x1, 88185x10 (88188x1 for global)

Flow User’s Guide has been updated and is now available for download from NeoLINK under Documentation.

IHC

HER2 Breast IHC Reporting - Effective as of March 13th, HER2 Breast IHC Reporting has been updated to include both CAP/ASCO guidelines and HER2 Low recommendations. As CAP/ASCO has not yet issued recommendations on HER2 Low results associated with the therapy Enhertu®, this update will allow our clients to report results and guide therapy decisions in a way that best supports patient care.

Reference ranges, scoring results and graphs that are displayed in the results section have been updated as shown below:

NOTE: Results reported that are considered either Equivocal/Low* or Negative/Low* will have an auto-populating comment appear on the report with information and references associated with HER2 Low.

Requisition Updates

The latest versions of the requisition forms for Heme services are now available, as listed below. They are available for download from the Neo website.

• Hematopathology Requisition – version 030323
• Oncology Office Hematology Requisition – version 021423
• New York Hematopathology Requisition – version 021523
• New York Oncology Office Hematology Requisition – version 022223

Please contact Client Services to order paper copies. In the meantime,

1. Download/print out these updated requisitions and use them to order, or
2. Write in orders from recent test updates on existing requisitions. See previous NeoNEWS for info on recent test updates.

*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 Discontinuations

Molecular

Thyroid Cancer Testing Program- Effective Saturday, April 1, The Lilly Oncology Sponsored Thyroid Cancer Testing Program (Thyroid STP), offering molecular testing at no cost to thyroid cancer patients, will be discontinued.

• Orders received and accessioned between now and March 31 will process through the Thyroid STP as normal.
• Orders received and accessioned on April 1 and beyond, will be put on hold while our Client Services team reaches out to inform on alternative testing options.

Lung Cancer Testing Program- Effective Sunday, April 16, The Lilly Oncology Sponsored Lung Cancer Testing Program (Lung STP), offering molecular testing at no cost to non-small cell lung cancer (NSCLC) patients, will be discontinued.

• Orders received and accessioned between now and April 15 will process through the Lung STP as normal.
• Orders received and accessioned on April 16 and beyond, will be put on hold while our Client Services team reaches out to inform on alternative testing options. Note: NeoTYPE^® DNA & RNA – Lung is the recommended alternative, as this was the test performed as part of the program.

For any questions on the discontinuation of these programs or for more information on alternative suggestions, please contact your local NeoGenomics Sales Consultant or our Client Services team at (866) 776-5907, option 3.

Additional Announcement

Online Orders 1.0 and 2.0

Required Documents Upload/Acknowledgement - To support obtaining complete information associated with an order, effective as of March 13th, 2023, a new acknowledgement prompt for uploading/sending documents has been added to Online Orders 1.0 and 2.0. Clients placing an order will now need to either upload required documents using the document uploader feature or indicate, via a checkbox, that the required documents will be sent along with the specimen. Documents required for submitting an order are:

• Face sheet
• Front/back of card for both primary and secondary insurance
• Medical records: Documentation support Medical Necessity of Test Performed (Office/Progress Notes, recent CBC, Path Reports, H&P [History & Physical], etc.)

For Online Orders 1.0 users, the prompt is located at the end of the order screen (see example below from Online Orders 1.0). For Online Orders 2.0 users, the prompt is located on the Billing screen.

Interface Updates

***IMPORTANT: NEW EFFECTIVE DATES***