The FDA quietly updated the registry that decides which cancer patients are eligible for which targeted drugs, and it changed the list's name in the process.
The List of FDA-Authorized Companion Diagnostic Devices was updated and republished on July 23, 2026, according to the agency's Center for Devices and Radiological Health. It was previously titled the List of Cleared or Approved Companion Diagnostic Devices. The rename reflects that entries now arrive through several different regulatory routes, including premarket approval, 510(k) clearance, De Novo classification and humanitarian device exemption.
The reason this obscure table matters to patients is simple. If a drug's label requires a specific biomarker, and a test is not authorized to detect that biomarker for that drug, the pathway from tumor to prescription does not connect. Insurers look at this list. So do oncologists.
What a Companion Diagnostic Actually Is
FDA defines a companion diagnostic as a device, either an in vitro test or an imaging tool, that provides information "essential for the safe and effective use of a corresponding therapeutic product."
The word essential is doing real work. A companion diagnostic is not a general screening test or a prognostic estimate. It is a gatekeeper. The drug's own labeling stipulates the test, and the test's labeling stipulates the drug. Neither is complete without the other.
That linkage is why authorization happens as a pair. When a drug is approved for patients with a specific mutation, FDA typically authorizes a matching test in parallel, a process called drug-diagnostic codevelopment. A test authorized for one drug is not automatically valid for another, even when both target the same gene. That is a common point of confusion for patients reading their own pathology reports.
FDA does maintain a second table for what it calls group labeling. Some tests are authorized for a defined group of oncology therapeutic products rather than a single named drug, which gives oncologists more flexibility within that class.
What Was Added This Year
The 2026 entries cluster in a few areas, and one of them represents a genuine shift.
Signatera CDx, from Natera, was authorized on May 15, 2026, under premarket approval P260004. It is indicated for muscle-invasive bladder cancer using plasma, and the biomarker is circulating tumor DNA molecular residual disease, paired with Tecentriq and Tecentriq Hybreza. This is different in kind from most of the list. Nearly every other entry detects a mutation that predicts whether a drug will work. This one detects whether traces of cancer remain in the bloodstream after treatment, and uses that to guide therapy decisions.
Liquid biopsy expanded substantially. Guardant360 Liquid CDx was authorized on May 19, 2026, under P250027 across multiple indications simultaneously, including breast cancer with Orserdu and Inluriyo, colorectal cancer with Braftovi and cetuximab, and non-small cell lung cancer with Tagrisso, Rybrevant, Lumakras and Enhertu. For patients whose tumors are difficult to biopsy, a plasma-based option can be the difference between getting a targeted therapy and not.
Prostate cancer gained several pairings. FoundationOne CDx and FoundationOne Liquid CDx were authorized on May 27, 2026, for homologous recombination repair gene alterations paired with Talzenna in combination with Xtandi. The VENTANA PTEN SP218 RxDx Assay was authorized on June 12, 2026, for metastatic hormone-sensitive prostate cancer with Truqap.
Other 2026 additions include Myriad myChoice CDx with Zejula in ovarian cancer, Guardant360 CDx with the newly approved zongertinib in HER2-mutant lung cancer, FoundationOne CDx with Tepmetko for MET exon 14 skipping, and two Ventana HER2 assays paired with Enhertu. The most recent entry on the list is PD-L1 IHC 28-8 pharmDx from Agilent, authorized July 1, 2026, for esophageal squamous cell carcinoma and gastric, gastroesophageal junction, and esophageal adenocarcinoma with Opdivo.
What This Changes for Patients and What It Does Not
If you or a family member has been diagnosed with cancer, the useful question to bring to an oncologist is whether biomarker testing has been done, which test was used, and whether that test is authorized for the specific drug under discussion.
Those are reasonable questions, and a treating oncologist should be able to answer them. Pathology reports frequently name the assay. If yours does not, the practice can tell you.
Several caveats matter. Authorization of a test does not mean the paired drug is right for any individual patient, and it does not mean the drug will work. It means the test is considered reliable enough to inform that decision. Nobody should start, stop, or change cancer treatment based on a registry update.
Coverage is a separate question from authorization. Insurers generally cover companion diagnostics when the corresponding therapy is being considered, but prior authorization requirements, network laboratory restrictions and out-of-pocket costs vary widely by plan. Patients facing a denial can ask their oncology practice about appeals, and many test manufacturers operate patient assistance programs. Medicare covers many FDA-authorized companion diagnostics under national coverage determinations for next-generation sequencing in advanced cancer, though the details depend on the specific test and indication.
Access is uneven in a way the list does not capture. Comprehensive biomarker testing is more consistently available at academic cancer centers in metros such as Boston, Houston, Seattle and Baltimore than at smaller community practices, and turnaround times differ. Patients treated outside large centers may need to ask explicitly whether tissue or plasma has been sent for testing rather than assuming it has.
What remains unknown is how quickly the newer categories will change practice. Molecular residual disease testing in particular is a young field, and its use to guide treatment decisions is expanding faster in some tumor types than the outcome evidence has accumulated in others.
FDA updates this list on a rolling basis as new authorizations are issued, with no fixed schedule. MedicalDaily will monitor the registry and report additions that meaningfully expand patient eligibility for targeted therapy.
Frequently Asked Questions
What is a companion diagnostic? A test or imaging tool that provides information FDA considers essential for the safe and effective use of a specific drug. The drug's label stipulates the test, and the test's label stipulates the drug.
Why did FDA rename the list? The previous title referred only to cleared or approved devices. Entries now arrive through several regulatory routes, including premarket approval, 510(k) clearance, De Novo classification, and humanitarian device exemption, which the term authorized covers.
What is the most significant 2026 addition? Signatera CDx, authorized May 15, 2026, for muscle-invasive bladder cancer. It detects circulating tumor DNA molecular residual disease rather than a predictive mutation, which is a different function from most entries on the list.
Does a test authorized for one drug work for another? Not automatically. Authorization is drug-specific unless the test carries a group labeling indication, which FDA tracks in a separate table for defined groups of oncology therapeutic products.
Will insurance cover these tests? Coverage is generally available when the paired therapy is under consideration, but prior authorization, network laboratory restrictions, and out-of-pocket costs vary by plan. Ask your oncology practice about appeals and manufacturer assistance programs.
What should I ask my oncologist? Whether biomarker testing has been performed, which specific assay was used, and whether that assay is authorized for the drug being considered. Your pathology report often names the test.
Does authorization mean the drug will work for me? No. It means the test is considered reliable enough to inform the decision. Treatment decisions depend on many factors beyond a single biomarker and belong to you and your oncologist.
