Molecular
Neo
Comprehensive™ Cancer Profiles – Effective Wednesday,
March 20th, the following updates will be applied to the gene
content for copy number variant (CNV) detection of the Neo Comprehensive
profiles for improved clinical utility.
- Neo Comprehensive – Myeloid Disorders
- Addition to the CNV reportable content: ABL1
and ETV6
- ABL1 amplification (as part of BCR::ABL1)
may be observed during chronic myeloid leukemia disease progression
(PMID: 20417874, 30399426).
- ETV6 copy loss is a frequent event in myeloid
neoplasia.
- Removal from the CNV reportable content: CDKN2B
and STAG2
- CDKN2B deletion will no longer
be reported separately from CDKN2A deletion, given
that both genes are typically deleted in combination.
- STAG2 deletion will no longer be reported, given
low incidence in myeloid neoplasia and the distinct calling criteria
in XX versus XY individuals (which may not be accurately discerned by
provided gender).
- New CNV content (17 genes): ABL1, ASXL1,
ATG2B,
BRAF,
CBFB,
CDKN1B,
CDKN2A,
DNMT1,
ETV6,
EZH2,
GSKIP,
JAK2,
KMT2A,
KRAS,
MYC,
RAD21,
TP53
- Neo Comprehensive – Heme Cancers
- Addition to the CNV reportable content: ATM
and ETV6
- ATM copy loss [del(11q)] is a frequent event in
chronic lymphocytic leukemia and is associated with adverse outcomes.
- ETV6 copy loss is a frequent event in myeloid
neoplasia.
- Removal from the CNV reportable content: STAG2
- STAG2 deletion will no longer be reported, given
low incidence in myeloid neoplasia and the distinct calling criteria
in XX versus XY individuals (which may not be accurately discerned by
provided gender)
- New CNV content (24 genes): ABL1, ASXL1,
ATM,
BRAF,
CBL,
CD274,
CDKN1B,
CDKN2A,
DNMT1,
EPOR,
ETV6,
EZH2,
FLT3,
IKZF1,
JAK2,
KMT2A,
KRAS,
MYC,
PAX5,
RAD21,
REL,
TNFRSF14,
TP53,
XPO1
Pricing and CPT codes
remain unchanged.
EGFR Mutation
Analysis by PCR – This test is now NYSDOH approved and
available for New York state orders!
This assay is designed to detect highly recurrent EGFR alterations in exon
18-21 (Exon 18 G719X; Exon 19 deletions; Exon 20 T790M, C797S, Exon20-Ins and
S768I; Exon 21 L858R, L861Q). Activating mutations in the EGFR gene have been
identified in approximately 20% of non-small cell lung cancer (NSCLC).
Identifying NSCLC patients with EGFR mutation is critical in determining
patient eligibility for targeted TKI therapies. For more test
details and specimen requirements, please visit the test
menu page.
PML-RARA
Translocation, t(15;17) – This test is now NYSDOH
approved and available for New York state orders!
It is a real-time RT-PCR assay for quantitative detection of both long and
short isoforms of the t(15;17) PML-RARA fusion transcript. Identification of
these fusion transcripts is essential in acute promyelocytic leukemia (APL)
because it is closely correlated with responsiveness to treatment with
all-trans retinoic acid (ATRA) or other specific therapy which substantially
improves survival of patients with the disease. Presence of this abnormality
in acute myeloid leukemia (AML) is associated with excellent outcome.
Specimen Requirements include:
- Bone marrow (preferred): 2
mL in EDTA tube
- Peripheral blood
(acceptable): 5 mL in EDTA tube
*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 Updates
New versions of the single
biomarkers solid tumor test requisitions, aligning with recent new product
launches and test updates, are available for download on our
website. For paper copy orders, please contact our Client Services team.
- Single Biomarkers and
Consults Solid Tumor Pathology Requisition ‒ version 021524
- Single Biomarkers and
Consults Solid Tumor Oncology Office Requisition ‒ version 021524
- New York State Single
Biomarkers and Consults Solid Tumor Pathology Requisition ‒ version 021524
- New York State Single
Biomarkers and Consults Solid Tumor Oncology Office Requisition ‒ version 02152
Test Discontinuations
Molecular
KRAS G12C Sponsored
Testing Program - Effective Sunday, March 31st, The
KRAS G12C Sponsored Testing Program (KRAS STP), offering no cost testing to
help identify KRAS G12C mutation in patients with advanced non-small cell
lung cancer (NSCLC), will be discontinued.
- Orders received and
accessioned between now and March 30 will process through the KRAS STP
as normal.
- Orders received and
accessioned on March 31 and beyond will be put on hold while our Client
Services team reaches out to inform on alternative testing options.
For any questions on the
discontinuation of this program or for more information on alternative
suggestions, please contact your local NeoGenomics Sales Consultant or our
Client Services team at (866) 776-5907, option 3.
For a complete list of
interface-related test changes, click here
for a downloadable document to view the impacted interface test codes.
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