Neogenomics Laboratories

NeoGenomics News

04/21/21 Special Announcement

Special Announcement

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

For more information on Amgen's Biomarker Assist KRAS Single Gene Testing Program or Next Generation Sequencing (NGS) Affordability Program, please visit or call Amgen Assist 360 at 1-888-4ASSIST (1-888-427-7478) for details.
04/21/21 Updates

Test Updates


JAK2: Effective April 26, 2021, the name of the JAK2 Exon 12-14 Mutation Analysis test will be changed to JAK2 Exon 12-13 Mutation Analysis. This test does not detect the common JAK2 V617F mutation that is located on exon 14. It is intended to detect non-V617F mutations only in exons 12-14 and most of exon 15. Hence, the test name will be updated to clarify which mutations can be detected.

  • New name will apply to all orders accessioned on April 26.
  • For cases that have been accessioned, there may be a difference in test name between reports (under old name) and invoices (under new name) after April 26.


NGS Fusion Panels are New York-approved: All 17 of our RNA-based NGS Fusion Panels for solid tumors are now approved and ready for patients in New York. Wherever you are in the US, please contact your Territory Business Manager for more information and to get the brochure with test-specific gene lists and suggested clinical applications. The Panels provide a variety of choices ranging in scope from 3 to 252 genes that reveal therapy and clinical trial opportunities in the rapidly growing area of gene fusions. Panels available are:

Universal Solid Tumor

Targeted Solid Tumor



Cholangio/Pancreatic Carcinoma


Ewing Sarcoma



NeoTYPE® Liposarcoma

Non-Ewing Sarcoma





Salivary Gland

Sarcoma Comprehensive

Important Billing Update

NeoGenomics has learned that insurance carrier Aetna follows CMS Guidelines when it comes to Professional and Technical Component processing. Effective May 1st, 2021, clients will be invoiced directly for the technical components of testing performed on hospital inpatients and hospital outpatients when requisitions are marked to bill insurance. Please read the letter from our billing department, which can be found a here, as well as an updated billing flow chart.


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.

New Test


As a reminder, PD-L1 LDT IHC will be available beginning April 26th, 2021. 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 high 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 April 26th, 2021, PD-L1 LDT will be used in several NeoTYPE® Tumor Profiles.



Interface related test/panel and result code changes for some NeoTYPE® Cancer Profiles will take place Monday, April 26, 2021.

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

If you have interface questions, please contact