Product information and disease description Place of product in therapy Disease description Burden of Adenoid cystic carcinoma with solid histology or high-grade transformation

Economic impact of diagnostic testing

5 evidence topics · 4 sources

Summary: diagnostic testing costs

Identification of aggressive ACC relies on histologic assessment of the solid component and of high-grade transformation on routine histologic sections, supported by immunohistochemistry. Molecular subtyping by MYC and p63 immunohistochemistry uses stains available in standard clinical pathology laboratories. Ancillary tests used in ACC include MYB::NFIB FISH, MYB RNA in situ hybridization, and next-generation sequencing for NOTCH1 and other alterations; MYB immunohistochemistry has been described as an inexpensive alternative to FISH. No ACC-specific study of diagnostic testing costs was identified. As a reference price for comprehensive genomic profiling, the Medicare payment amount for FoundationOne CDx (0037U) during its new advanced diagnostic laboratory test initial period was $3,500.00.

Immunohistochemistry for molecular subtyping: availability in routine pathology laboratories

“Immunohistochemical detection of both MYC and P63 are commonly used in clinical histology laboratories making them ideal for clinical translation.” (opens the source at this quote in a new tab)
“A major strength of our study is that our proposed classification encompasses all ACCs, has a stronger prognostic value than disease stage and histological subtype, and of direct clinical relevance, the two biologically distinct subgroups can be largely differentiated by using standard immunohistochemistry staining available in any clinical pathology lab (P63/MYC)” (opens the source at this quote in a new tab)

MYB testing: relative cost of immunohistochemistry and FISH

“MYB IHC was soon touted as an inexpensive practical alternative to FISH or other molecular testing.” (opens the source at this quote in a new tab)

Comprehensive genomic profiling: Medicare payment for FoundationOne CDx

Field	Quoted record
Test code	“0037U”
Test name	“FoundationOne CDx”
Test descriptor	“Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden”
New ADLT initial period	“7/1/18 - 3/31/19”
Payment amount for dates of service before initial period	“Contractor Priced”
Payment amount for dates of service during new ADLT initial period	“$3,500.00”

Commercial molecular profiling used to classify ACC-I and ACC-II

“This retrospective observational cohort study involved de-identified samples from 438 patients with ACC with tumor samples sent for commercially-available molecular profiling (Caris Life Sciences).” (opens the source at this quote in a new tab)