November 20, 2024
The vendor supply disruption affecting the following tests, inv(16), CBFB-MYH11 Translocation and RUNX1-RUNX1T1 (AML1-ETO) Translocation, t(8;21) and MET Exon 14 Deletion Analysis, has been resolved.
We apologize for the inconvenience this disruption may have caused.
New Tests
NeoGenomics is proud to announce a new Flow assay for the assessment of Minimal Residual Disease (MRD) in patients with acute myeloid leukemia (AML). AML MRD Flow Panel can be used as a prognostic/predictive assay for risk assessment and treatment decision making and to monitor for relapse. Sensitivity meets or exceeds ELN-defined requirements for flow-based AML MRD testing and supports tailoring of treatment plans that may lead to better patient outcomes.
AML MRD Flow Panel is a 20-biomarker panel containing unique markers that can detect aberrant overexpression in leukemic myeloblasts to complement classic markers recommended by ELN MRD Working Party.
- Markers: CD7, CD11b, CD13, CD14, CD15, CD16, CD19, CD2, CD33, CD34, CD38, CD4, CD45, CD56, CD64, CD65, CD87, CD117, CD371, HLA-DR
Test Details:
- Specimen Requirements: Bone marrow aspirate: 2-3 mL, first pull. EDTA preferred. Sodium heparin tube acceptable.
- Turnaround Time (TAT): 1-2 days
- CPT Codes*: 88184x1, 88185x19. Add 88189x1 for global.
- NYS Approval? No
For more info, please contact your local Territory Business Manager or visit the test menu page here.
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.
Test Details:
- Level of Service: Global and Tech-Only
- CPT Code*: 88360x1
- Turnaround Time (TAT): Global: 48 hours, Tech-Only: 24 hours
- NYS Approval? Yes
1. www.gastriccancerbiomarkers.com/
*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.
Flow Cytometry
Breast fluid specimens – As of Monday, November 18th, all Global Flow orders submitted with breast fluids/seromas (implant fluid, FNA, etc.) will now be automatically processed with the TRBC1/T-Cell Lymphoma Companion Panel (TRBC1/TLCL) at Global level of service as this assay is the most appropriate testing course for these sample types. Once TRBC1/TLCL Panel has been completed, if medically necessary, additional panels (e.g. Standard Leukemia/Lymphoma Panel or T&B Tissue Panel) may be added if sufficient specimen remains.
- The TRBC1/TLCL Panel assesses T-cells for the presence of CD30 and other targetable antigens to guide the diagnosis and therapeutic decisions. Expression of CD30 is important in the evaluation of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and the other antibodies in the panel may also help with differential diagnosis of various other T-cell lymphomas or leukemias.
- A test order change will be automatically processed to switch the original panel order (if not TRBC1/TLCL Panel) to TRBC1/T-Cell Lymphoma Companion Panel. Clients will be notified of the change.
- For ease of processing, for all breast fluid specimens, please order the TRBC1/T-Cell Lymphoma Companion Panel.
For any questions, please contact your local Territory Business Manager or our Client Services team.
FOLR1 Sponsored Testing Program for Ovarian Cancer
NeoGenomics Laboratories is partnered with ImmunoGen, now part of AbbVie, on a FOLR1 testing program to provide testing for folate receptor alpha (FRα), an actionable biomarker in ovarian cancer, to eligible patients through December 30, 2024.
This testing program was designed to help reduce barriers to IHC testing for novel biomarkers and aid oncologists in making informed treatment decisions for their ovarian cancer patients.
Testing for FRα expression is performed using the FDA-approved immunohistochemistry (IHC) companion diagnostic (CDx)—VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. This CDx may indicate eligibility for treatment with the associated biomarker-driven therapy.
To learn more about this program, the patient eligibility criteria, and to download the test requisition form, please visit our webpage.
Additional Announcement
Thanksgiving Holiday Schedule
Logistics: FedEx is closed on Thursday, November 28th for the US Thanksgiving Day holiday (no pickups or deliveries). Any specimens shipped from client locations on Wednesday, November 27th will have an expected delivery day of Friday, November 29th. Though regularly scheduled daily pick-ups will not occur on Thursday, November 28th, we are available to pick up STAT cases or specimens where viability is a concern. For these cases, please call Client Services at 866.776.5907, option 1 for assistance.
Operations: NeoGenomics Operations will continue to process samples on Thanksgiving Day, Thursday, November 28th to deliver quality test results with no delays to turnaround time caused by the holiday.
Client Services: Representatives will be available to provide assistance as needed on Thursday, November 28th. Please call 866.776.5907, and press option 3.
Billing: Please call 866.776.5907, press option 2, and follow the prompts to leave a message. Your call will be returned on Monday, December 2nd.