04/21/21 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
- 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.
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
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:
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
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.
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.
- 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
Solid Tumor Profile Updates
Beginning with samples received April 26th, 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,
and Soft Tissue, Liver/Biliary,
Solid Tumor, Ovarian,
- 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 April 26th, 2021
CLIENTS and IT STAFF***
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 InterfaceTeam@Neogenomics.com.