UnitedHealthcare PA: March 2026 — Explicit FDA‑Cleared Companion Diagnostics & Oncomine Updates

Effective March 1, 2026, UnitedHealthcare Pennsylvania updated CS373PA.E to explicitly list multiple FDA‑cleared/approved companion diagnostics and their specific drug–indication pairings, including expanded listings for the Oncomine™ Dx family (Target and Express tests). FoundationOne® CDx, MI Cancer Seek™, oncoReveal™ CDx, TruSight™ Oncology Comprehensive and others are enumerated as proven/medically necessary for defined tumor types (e.g., cholangiocarcinoma, NSCLC, astrocytoma, oligodendroglioma) linked to FDA‑approved therapies. The Oncomine™ Dx Target Test is detailed (gene/fusion content) and is now tied to specific therapy pairings such as pembrolizumab and sunvozertinib for NSCLC in the revision history. For ampullary adenocarcinoma the policy aligns with NCCN guidance, supporting FDA‑approved or validated NGS assays to detect actionable alterations (FGFR2, NTRK, MSI, BRCA, HER2, etc.) in advanced disease.

This revision (effective 2026-03-01) expands the UnitedHealthcare Pennsylvania-only policy CS373PA.E to explicitly list additional FDA-cleared/approved companion diagnostic assays and their specific indication/drug pairings. The policy text shows new or clarified device–therapy pairings across multiple tumor types, and it includes updates to the Oncomine™ Dx family of tests and their labeled indications. Notable explicit inclusions in the document are listings for FoundationOne® CDx, MI Cancer Seek™, oncoReveal™ CDx, TruSight™ Oncology Comprehensive, xT CDx, and Oncomine™ Dx Target Test (Life Technologies Corporation).

The Policy History/Revision Information block indicates recent additions related to the Oncomine™ Dx Express Test and Oncomine™ Dx Target Test for management of specific indications — for example, Oncomine™ Dx Target Test is listed as proven and medically necessary for astrocytoma, cholangiocarcinoma, NSCLC, and oligodendroglioma with explicit drug pairings. The revision also includes updated pairings linking Keytruda® (pembrolizumab) and () to the for NSCLC.

FoundationOne® CDx is affirmed as "proven and medically necessary" in this policy when used to inform management for a set of listed tumor types and their corresponding FDA-approved therapies. The policy enumerates breast cancer therapies (e.g., Herceptin®, Kadcyla®, Perjeta®, Piqray®, Truqap® in combination with Faslodex®), cholangiocarcinoma with Pemazyre® (pemigatinib), colorectal cancer with anti-EGFR agents (Erbitux®, Vectibix®), low-grade glioma with Ojmeda® (tovorafenib), and multiple melanoma-directed regimens including Mekinist®, Tafinlar®, Tecentriq® in combination with Cotellic® and Zelboraf®, and Zelboraf® alone.

This listing ties the use of FoundationOne® CDx directly to specific therapeutic decision points — the policy identifies the companion diagnostic as clinically appropriate when used to manage patients being considered for those listed drugs.

MI Cancer Seek™ is similarly listed as "proven and medically necessary" for specified indication/drug pairings. The policy includes cholangiocarcinoma paired with Tibsovo® (ivosidenib), and multiple NSCLC-related drug pairings such as Enhertu®, Gavreto®, Hernexeos®, Iressa®, Retevmo®, Rybrevant®, Tafinlar®, and Xalkori®. Other tumor types covered under MI Cancer Seek™ include astrocytoma and oligodendroglioma (both with Voranigo®/vorasidenib), and thyroid cancers (anaplastic and medullary) with FDA-labeled targeted therapies.

This policy text therefore recognizes MI Cancer Seek™ as an acceptable companion diagnostic across a range of central nervous system, thoracic, and biliary indications where the device’s results would inform FDA‑approved targeted treatments.

The document includes coverage statements for other NGS-based FDA-cleared/approved assays. oncoReveal™ CDx is listed as proven and medically necessary for colorectal cancer (with Erbitux® and Vectibix®) and NSCLC with multiple EGFR/ALK-targeted agents. TruSight™ Oncology Comprehensive is designated for NSCLC (with Retevmo®) and for solid tumors when guiding use of Vitrakvi® (larotrectinib). The policy also references xT CDx (no pairings shown in the excerpt) and expands the Oncomine™ Dx family: the Oncomine™ Dx Target Test is described in technical terms (23 genes, fusions in ROS1/RET, IDH1 in cholangiocarcinoma, etc.) and its proven/medically necessary pairings are reiterated in the revision history.

These inclusions reflect UnitedHealthcare’s delineation of which specific FDA-cleared companion diagnostic platforms are considered medically necessary for particular tumor types and therapy matches in Pennsylvania.

For ampullary adenocarcinoma, the policy references NCCN guidance (NCCN, 2025a) that testing for potentially actionable somatic findings via an FDA-approved and/or validated NGS-based assay is recommended as an option for individuals with locally advanced/metastatic disease who are candidates for anticancer therapy. The policy enumerates analytes of interest — fusions (e.g., ALK, NRG1, NTRK, ROS1, FGFR2, RET), mutations (e.g., BRAF, BRCA1/2, KRAS, PALB2), amplifications (e.g., HER2), MSI, MMR deficiency, or TMB — indicating the scope of molecular alterations the policy contemplates as actionable in this tumor type.

This section situates UnitedHealthcare’s Pennsylvania-specific policy within NCCN-recommended practice for ampullary adenocarcinoma, by recognizing that comprehensive NGS-based tumor profiling can identify therapeutic opportunities.

OpenPayer

March 2026 Revision: Explicit FDA-cleared Companion Diagnostic Listings and Oncomine Test Updates

FoundationOne® CDx: Listed Indication–Drug Pairings (including Cholangiocarcinoma)

MI Cancer Seek™: Indications and Drug Pairings (cholangiocarcinoma included)

Other FDA‑cleared NGS Companion Diagnostics and Their Listed Uses

Ampullary Adenocarcinoma: NCCN‑Referenced NGS Testing Scope