Upcoming Tests - Available May 17^th, 2021

FISH

ALCL FISH Panel - Is used in detection of recurrent chromosome abnormalities, such as ALK and TP63, in order to help classify patients with anaplastic large cell lymphoma (ALCL) or peripheral T-cell lymphoma (PTCL) into specific risk groups.

• Probe(s): ALK (2p23) | TP63 (3q28) | TBL1XR1/TP63 [inv(3)(q26q28)] | DUSP22-IRF4 (6p25.3)
• TAT: 3-5 Days
• Levels of service: Global and Tech-Only
• CPT Code(s): 88374x4 automated or 88377x4 manual

TFE3 Rearrangement - Chromosome Xp11.2 translocations causing TFE3 gene rearrangement and fusions define the "MiT family translocation RCC" category in the 2016 WHO renal cell carcinoma (RCC) classification. This break-apart FISH test may be used to diagnose this RCC subtype and in diagnosis of alveolar soft part sarcoma (ASPS), a rare soft tissue tumor caused by balanced or unbalanced translocation between TFE3 and the ASPL gene on chromosome 17. FISH has been reported to be more reliable in detecting translocations than TFE3 IHC.

• Probe: TFE3 (Xp11.2)
• TAT: 3-5 days
• Levels of service: Global and tech-only
• CPT Code(s): 88374x1 automated or 88377x1 manual

USP6 Rearrangement - USP6 gene rearrangements (fusions) are commonly found in nodular fasciitis (NF), aneurysmal bone cysts (ABC), myositis ossificans (MO), fibro-osseous pseudotumor of digit (FOTD), and fibroma of tendon sheath. Presence of a USP6 rearrangement can serve as a valuable marker for differentiating these neoplasms, many of which are self-limiting, from other neoplasms and malignancies with similar histological appearance. This test uses a break-apart probe.

• Probe: USP6 (17p13.2)
• TAT: 3-5 days
• Levels of service: Global and tech-only
• CPT Code(s): 88374x1 automated or 88377x1 manual

IHC

PD-L1 LDT-This lab developed test uses the Zeta PD-L1 monoclonal antibody clone ZR3 to detect PD-L1 in FFPE tissues. Validation of the PD-L1 LDT was performed on a variety of tumor types including NSCLC, breast, gastric/GEA, ovarian, prostate, and others, and included comparison to PD-L1 22C3 IHC. The data generated showed 95% concordance of positive and negative results between the stains across the different tumor types tested, providing confidence in the PD-L1 LDT performance.

• Scoring
• Tumor cells with partial or complete membrane staining (≥1+) and tumor-associated lymphocytes and macrophages (inflammatory cells) with membrane and/or cytoplasmic staining (≥1+) are scored.
• Total PD-L1 score is the sum of the number of staining tumor cells and inflammatory cells divided by the number of total viable tumor cells. Results are reported as “detected” if the total score is ≥1 and “not detected” if <1.
• This algorithm is comparable to Combined Positive Score (CPS) calculation that is used with PD-L1 22C3.
• Levels of service: Global and tech-only
• CPT Code: 88360x1

NeoTYPE^® Solid Tumor Profile Updates

Beginning with samples received Monday, May 17th, 2021, PD-L1 LDT will be used in several NeoTYPE^® Tumor Profiles.

• Test substitution: PD-L1 LDT will replace the current off-label PD-L1 22C3 FDA (KEYTRUDA^®) for Gastric/GEA in the following profiles: NeoTYPE^® Brain, Colorectal, Discovery (Other), Endometrial, GIST and Soft Tissue, Liver/Biliary, Other Solid Tumor, Ovarian, Pancreas, Precision, and Thyroid.
• No changes to level of service, CPT Codes, or TAT
• Test addition: PD-L1 LDT will be added to the NeoTYPE^® HRD+ Profile, which does not currently have PD-L1 IHC testing, to provide additional potential therapy options for these patients.
• Please add CPT Code 88360x1 to NeoTYPE^® HRD+ Profile beginning May17th, 2021

***ATTENTION INTERFACE CLIENTS and IT STAFF***

Interface related test/panel and result code changes for some NeoTYPE^® Cancer Profiles will take place Monday, May 17, 2021.

To view the revised interface updates and new test codes, please click here for a downloadable document.

If you have interface questions, please contact InterfaceTeam@Neogenomics.com.

Discontinued Test

Molecular

HRAS Mutation Analysis stand-alone testing will be discontinued, due to low usage, effective Monday, May 17th, 2021. HRAS gene analysis remains part of the RAS/RAF Panel in addition to many of our NeoTYPE^® Solid Tumor Profiles.

Important Billing Update

CPT Code Changes

CPT Code and Z-Code changes for NexCourse® Complete: Recently, the Molecular Diagnostic Services (MolDX^®) Program changed codes that NeoGenomics uses to bill our Medicare Contractor, Noridian, for the NexCourse Complete NGS panel used primarily by our New York Clients. Please see below for updated CPT Codes that will be billed for samples invoiced as of Monday, May 3rd, 2021. We also encourage clients who are required to utilize Z-codes when submitting claims to Medicare to log into the DEX^™ Diagnostics Exchange to obtain updated Z-codes for the following tests.

The CPT Codes provided 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.

Sponsored Testing Program

Biomarker Assist™ KRAS Single Gene Testing (SGT) Program

We are excited to share that Amgen has engaged with NeoGenomics to launch the Biomarker Assist™ KRAS Single Gene Testing (SGT) Program that provides access to single gene KRAS testing for all advanced or metastatic (stage IV) patients with non-small cell lung cancer (NSCLC) at no cost to patients. The KRAS SGT Program is an Amgen sponsored testing program.

• Test Details: The KRAS SGT Program includes one (1) KRAS Mutation Analysis by Sanger Sequencing per patient.
• Patient Eligibility: The program covers all advanced or metastatic (stage IV) non-small cell lung cancer patients.

Find out how you can enroll your patients in the KRAS Single Gene Testing Program by visiting NeoGenomics.com/KRAS-G12C.

For more information on Amgen's Biomarker Assist™ KRAS Single Gene Testing Program or Next Generation Sequencing (NGS) Affordability Program, please visit biomarkerassist.com or call Amgen Assist 360™ at 1-888-4ASSIST (1-888-427-7478) for details.

Precision Medicine Podcast

Bill Bonello, president of NeoGenomics Informatics division, and Clynt Taylor, president of Trapelo Health, discuss challenges in precision medicine and how evidence-based technologies can help deliver more appropriate, value-based care to more patients.

As a subtext to the discussion is the recent acquisition of Trapelo Health, creator of clinical decision-making platform Trapelo, by NeoGenomics Informatics, provider of bioinformatics services. This acquisition is aimed at improving access to precision medicine testing and treatment.

Hear the Podcast