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Test Code NEUD1 Neuronal Differentiation 1 (NeuroD1), Technical Component only


Ordering Guidance


This test includes only technical performance of the stain (no pathologist interpretation is performed). If diagnostic consultation by a pathologist is required order PATHC / Pathology Consultation.



Shipping Instructions


Attach the green "Attention Pathology" address label (T498) and the pink Immunostain Technical Only label included in the kit to the outside of the transport container.



Specimen Required


Supplies: Immunostain Technical Only Envelope (T693)

Specimen Type: Tissue

Container/Tube: Immunostain Technical Only Envelope

Preferred:

Formalin-fixed, paraffin-embedded tissue block

OR

2 Unstained, positively charged glass slides (25- x 75- x 1-mm) per test ordered; sections 4-microns thick

Acceptable: None

 


Useful For

Subclassification of small cell lung carcinoma

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
IHTOI IHC Initial, Tech Only No No
IHTOA IHC Additional, Tech Only No No

Testing Algorithm

For the initial technical component only immunohistochemical (IHC) stain performed, the appropriate bill-only test ID will be reflexed and charged (IHTOI). For each additional technical component only IHC stain performed, an additional bill-only test ID will be reflexed and charged (IHTOA).

Method Name

Immunohistochemistry (IHC)

Reporting Name

NeuroD1 IHC, Tech Only

Specimen Type

TECHONLY

Specimen Stability Information

Specimen Type Temperature Time
TECHONLY Ambient (preferred)
  Refrigerated 

Reject Due To

Wet/frozen tissue
Cytology smears
Nonformalin fixed tissue
Nonparaffin embedded tissue
Noncharged slides
ProbeOn slides
Reject

Clinical Information

Neuronal Differentiation 1 (NeuroD1) is expressed in a variety of cancers including but not limited to colorectal, pancreatic, small cell (of cervix and lung), and neuroendocrine lung carcinomas and may play a major role in neuroendocrine differentiation. There are four major subclasses of small cell carcinoma of lung and cervix, one of which dominantly expresses NeuroD1. The subclassification of small cell lung carcinomas could provide distinct therapeutic options.

Interpretation

This test does not include pathologist interpretation, only technical performance of the stain. If interpretation is required, order PATHC / Pathology Consultation for a full diagnostic evaluation or second opinion of the case.

 

The positive and negative controls are verified as showing appropriate immunoreactivity. If a control tissue is not included on the slide, a scanned image of the relevant quality control tissue is available upon request; call 855-516-8404.

 

Interpretation of this test should be performed in the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Cautions

Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen dependent. Best practice is for paraffin sections to be cut within 6 weeks.

 

Recommended fixation time is between 6 and 48 hours.

 

This assay has not been validated on tissues subjected to the decalcification process or use of alternative fixatives for bone and bone marrow specimens or cell blocks.

Clinical Reference

1. Li Z, He Y, Li Y, et al. NeuroD1 promotes tumor cell proliferation and tumorigenesis by directly activating the pentose phosphate pathway in colorectal carcinoma. Oncogene 2021 40:6738-6747

2. Wang Y, Su D, Gao L, et al. Effect of NeuroD gene silencing on the migration and invasion of human pancreatic cancer cells PANC-1. Cell Biochem Biophys. 2014 69:487-494

3. Kim G, Kim M, Nam EJ, Lee JY, Park E. Application of Small Cell Lung Cancer Molecular Subtyping Markers to Small Cell Neuroendocrine Carcinoma of the Cervix: NEUROD1 as a Poor Prognostic Factor. Am J Surg Pathol. 2024;48(3):364-372

4. Osborne J, Larsen J, Shields M, et al. NeuroD1 regulates survival and migration of neuroendocrine lung carcinomas via signaling molecules TrkB and NCAM. Proc Natl Acad Sci USA. 2013 110:6524-6529

5. Gay C, Stewart C, Park E, et al. Patterns of transcription factor programs and immune pathway activation define four major subtypes of SCLC with distinct therapeutic vulnerabilities. Cancer Cell 2021 39:3(3)46-60

6. Baine M, Hsieh M, Lai V, et al: SCLC subtypes defined by ASCL1, NEUROD1, POU2F3, and YAP1: A comprehensive immunohistochemical and histopathologic characterization. J Thorc Oncol. 2020;15(12):1823-1835

Method Description

Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)

Day(s) Performed

Monday through Friday 

Report Available

1 to 3 days

Specimen Retention Time

Until staining is completed

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

88342-TC, Primary

88341-TC, If additional IHC

LOINC Code Information

Result ID Test Result Name Result LOINC Value
622268 NeuroD1 IHC, Tech Only No LOINC Needed

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send an Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.