Neogenomics Laboratories

NeoGenomics News

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6/19/2024

Special Announcement

                                        ***Revised 6/21***

On April 5, 2024, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (ENHERTU) for adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options (read more about the approval here).

While the DESTINY clinical trials used ASCO-CAP scoring criteria for Gastric/GEJ adenocarcinoma in metastatic solid tumors for HER2 IHC testing and scoring, it is important to recognize the following:

  1. There is NO new HER2 “Pan-Tumor” IHC test
  2. There are NO new HER2 interpretation guidelines or consensus (e.g. CAP/ASCO)
  3. There is NO evidence that one score works better than another in pan-tumor indications
  4. ENHERTU® (fam-trastuzumab deruxtecan-nxki) is indicated in adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.  Please note that the approval (and ENHERTU® Package Insert) does NOT state if HER2 2+ IHC/FISH positive tumors are acceptable for therapy with fam-trastuzumab deruxtecan-nxki.
  5. In addition, please note that CAP Template for Reporting Results of Biomarker Testing of Specimens From Patients With Carcinoma of Gynecologic Origin (Version: 1.1.0.0; March 2023),  in the absence of conclusive data, suggests using a similar reporting format as that used for reporting the results of HER2 testing for breast cancer, with modification in the definition of positive score (3+) as “Intense complete or basolateral/lateral membrane staining in over 30% of tumor cells”.

NeoGenomics offers several variations of HER2 IHC and FISH, allowing our clients to order the scoring scheme of their choice. However, in the absence of any instructions to the contrary, NeoGenomics will continue to follow the suggestions from CAP and default to HER2 Other – Breast score for all tumor-agnostic indications (except for Breast and Gastric/GEJ adenocarcinomas).

Please note: Articles of reference used for this data can be requested by replying to this email.

 

Test Updates

Medicare MolDx CPT code updates

Please note that we have updated the MolDx CPT codes for Sarcoma Comprehensive NGS Fusion Panel and Universal Solid Tumor NGS Fusion Panel from 81449 to 81479. The change has been reflected on our Test Menu.

*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.

 

FOLR1 Sponsored Testing Program for Ovarian Cancer

NeoGenomics Laboratories is partnered with ImmunoGen, Inc. on a FOLR1 testing program to provide testing for folate receptor alpha (FRα), an actionable biomarker in ovarian cancer, to eligible patients.

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.

   

Interface Updates

For a complete list of interface-related test changes, click here for a downloadable document to view the impacted interface test codes.