Neogenomics Laboratories

NeoGenomics News

11/30/2022

Special Announcement

IHC - PD-L1 SP142- Notice of Roche Urgent Medical Device Correction

On November 21, 2022, NeoGenomics received an Urgent Medical Device Correction notice from Roche pertaining to specific lot numbers of the Ventana PD-L1 (SP142) assay resulting in unacceptable light staining requiring review of any negative results. At this time there is no action needed from our clients.
We appreciate your patience as we work towards a resolution. Should you have any questions or need any assistance, please do not hesitate to contact your local NeoGenomics Sales Consultant or our Client Services team at (866) 776-5907, option 3.

 

New Test

Now Available - FOLR1 Sponsored Testing Program

Folate Receptor alpha (FRα) protein expression in patients with platinum-resistant ovarian cancer is now actionable. NeoGenomics is pleased to partner with ImmunoGen on a FOLR1 sponsored testing program initiative called FR-ASSIST™, providing access to the newly FDA-approved FOLR1 Immunohistochemistry companion diagnostic (CDx) test for ovarian cancer (including epithelial ovarian cancer, fallopian tube or primary peritoneal cancer) at no cost to eligible patients.

Test Details: The FOLR1 Sponsored Testing Program includes one (1) FOLR1 FDA (ELAHERE™) for Ovarian Carcinoma test per patient.

Ordering: Please use the FOLR1 Sponsored Testing Program Requisition to participate in the program.

To learn more about the program, eligibility criteria and to download the test requisition form, visit the FOLR1 Sponsored Testing Program webpage.

 

FISH

BCL6/MYC t(3;8) by FISH is now available!

  • BCL6/MYC translocation is observed recurrently in high-grade B-cell lymphoma, reported in the literature as “pseudo” double-hit or non-Ig/MYC translocation; however, it has a better prognosis than double hit/triple hit lymphomas with Ig/MYC translocations.
  • Specimen requirements: Paraffin block or cut slides
  • TAT: 3-5 days
  • Level of service: both Global and Tech-only options available
  • NYS Approval: No

 

Test Updates

2023 AMA CPT Code Changes
Good news! AMA CPT Code revisions are limited to 13 of our NGS Fusion Panels as described below. Ewing, Rhabdomyosarcoma, NTRK, and NTRK & RET NGS Fusion Panels are not impacted. Please note these changes are effective Monday, January 2nd.

 

Panel Name

Current AMA CPT Code

Current MolDX CPT Code

2023 AMA CPT Code

2023 MolDX CPT Code

Brain NGS Fusion Panel
Breast NGS Fusion Panel
Cholangio/Pancreatic Carcinoma NGS Fusion Panel
Colorectal NGS Fusion Panel
Lung Complete NGS Fusion Panel
Lung Limited NGS Fusion Panel
Prostate NGS Fusion Panel
Salivary Gland NGS Fusion Panel
Targeted Solid Tumor NGS Fusion Panel
Thyroid NGS Fusion Panel

81445

81445

81449

81449

Non-Ewing Sarcoma NGS Fusion Panel

81445

81479

81449

81479

Sarcoma Comprehensive NGS Fusion Panel
Universal Solid Tumor NGS Fusion Panel

81455

81455

81456

81449

 

IHC

TS IHC Discontinuation - We want to provide a bit of clarification around this recent test discontinuation. The test Thymidylate Synthase (also known as TS) had two test codes in our system for the same test. The test named ‘TS’ was discontinued effective November 21st. The test named ‘Thymidylate Synthase’ remains active and orderable. We apologize for any confusion this may have caused.

 

Molecular

NeoTYPE® Ovarian Profile- Add-on FOLR1 IHC Testing

Effective as of November 18, clients ordering the NeoTYPE® Ovarian Profile can now add-on FOLR1 IHC testing.

  • FOLR1 IHC testing is indicated as an aid in identifying patients with ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer or primary fallopian tube cancer)
  • Available as Global level of service, please add CPT 88360
  • To order, please write-in ‘add FOLR1 IHC’ on the NGS Testing Requisition or comments in Online Orders. For Interfaced clients, please see the Interface Updates section of NeoNEWS.
  • Note: FOLR1 IHC when added on to the NeoTYPE® Ovarian Profile will be billed according to the Bill Type on the requisition. If you would like to utilize the FOLR1 Sponsored Testing Program for FOLR1 IHC testing instead, please visit the FOLR1 Sponsored Testing Program webpage for more information.

 

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.

 

Requisition Update

The new versions of the below requisitions for Heme services are now available. They are downloadable on Neo website. Paper copies can be ordered with Client Services.

  • Hematopathology Requisition – version 111122
  • New York Hematopathology Requisition – version 111322

   

Interface Updates

For the complete list of interface-related test changes that took effect Monday November 21st, click here for a downloadable document to view the impacted interface test codes.

UPDATE: Please reactivate: HSV1/2 test code 3247XHSG

IMPORTANT NOTE:
Electronic ordering of the following tests is not available at this time, but it is planned to be available in December.
-FOLR1 FDA (ELAHERE™) for Ovarian Carcinoma, Sponsored Testing Program
-(Any) NeoType Ovarian with the FOLR1 FDA (ELAHERE™) for Ovarian Carcinoma

Paper requisitions are available here.

For temporary order and result options, please contact the InterfaceTeam@Neogenomics.com for further details.