Markers used to select, monitor, or stratify treatment, including MRD assays and companion diagnostics.
A JAMA Oncology analysis published online August 13, 2026, of 1,026 plasma samples from 159 patients in the c-TRAK TN surveillance cohort found that tissue-free ctDNA detection was associated with recurrence (HR 27.2; 95% CI 13.7 to 54.2), and median lead time to recurrence was 7.6 months with the tissue-free assay versus 7.1 months with a multivariant tumor-informed assay.
JAMA Oncology
At ESMO 2026, the PROMPT matched tissue-and-plasma series of 301 patients with metastatic castration-resistant prostate cancer reported that plasma ctDNA detected 50 of 61 patients with a BRCA1/2 or other HRR mutation and added 4 patients beyond tissue sequencing, with matched leukocyte DNA used to separate clonal hematopoiesis.
UroToday
On May 15, 2026, the FDA approved atezolizumab and atezolizumab/hyaluronidase as adjuvant treatment for adults with muscle-invasive bladder cancer after cystectomy who have ctDNA molecular residual disease on an FDA-authorized test, and approved Signatera CDx to select those patients; in IMvigor011 median disease-free survival was 9.9 versus 4.8 months (HR 0.64) and median overall survival was 32.8 versus 21.1 months (HR 0.59).
U.S. FDA
A Cell paper published online November 7, 2025, applied a whole-genome tumor-informed ctDNA assay to 2,994 plasma samples from 431 patients with non-small cell lung cancer in TRACERx and reported that detection below 80 parts per million, before and after surgery, was prognostic, and that patients who cleared ctDNA during adjuvant therapy had better outcomes.
Cell
On July 31, 2026, the FDA approved lutetium Lu 177 vipivotide tetraxetan with an androgen-receptor pathway inhibitor for PSMA-positive metastatic androgen-pathway-naive or -sensitive prostate cancer, with patients selected using Locametz or another approved PSMA PET product; in PSMAddition (1,144 patients) radiographic progression-free survival HR was 0.72 and median radiographic progression-free survival was not reached in either arm.
U.S. FDA
In a 66-patient retrospective series presented at ASCO GU 2026, baseline Signatera ctDNA positivity before curative-intent treatment for urothelial carcinoma was associated with shorter recurrence-free survival (HR 5.15; 95% CI 1.41 to 18.78).
Journal of Clinical Oncology
An ASCO GU 2026 proof-of-concept series of 33 ctDNA samples from 21 patients with germ cell tumors, most of them marker-negative, reported 100% concordance between ctDNA detection and radiologic or pathologic disease status across the treatment phases assessed.
Journal of Clinical Oncology
Among 64 patients with ctDNA drawn before primary retroperitoneal lymph node dissection, an ASCO GU 2026 analysis reported sensitivity of 88% and specificity of 85% for germ cell tumor in the non-seminoma subgroup of 37 patients; seminoma specificity could not be estimated because every seminoma specimen contained tumor.
Journal of Clinical Oncology
An ASCO GU 2026 retrospective series of patients with testicular cancer who had at least one tumor-informed ctDNA result reported that, in that chart review, ctDNA was more sensitive and specific than serum tumor markers and imaging for residual disease and recurrence.
Journal of Clinical Oncology
In a biomarker analysis of the phase 2 COMRADE trial presented at ASCO GU 2026, undetectable ctDNA at cycle 2 day 1 was associated with longer radiographic progression-free survival than detectable ctDNA (median 9.9 versus 2.7 months; HR 0.47) among 94 analyzed patients with bone-dominant metastatic castration-resistant prostate cancer.
UroToday
A multicenter series of 77 patients with stage I to IV renal cell carcinoma, published in JCO Oncology Advances on January 21, 2026, found that Signatera ctDNA positivity in the molecular-residual-disease window was associated with inferior recurrence-free survival in the landmark analysis (HR 18; 95% CI 4.9 to 67).
JCO Oncology Advances
A Journal for ImmunoTherapy of Cancer analysis published July 11, 2025, of adjuvant nivolumab with or without ipilimumab in resected stage III or IV melanoma found tumor-informed ctDNA at baseline in 16.2% of tested patients, and ctDNA positivity at baseline or on treatment was associated with recurrence (HR 1.97; 95% CI 1.57 to 2.46).
Journal for ImmunoTherapy of Cancer
In the January 13, 2025 Nature Medicine TRACERx analysis, lung adenocarcinomas with preoperative ctDNA detected below 80 parts per million still had worse overall survival than ctDNA-negative adenocarcinomas (HR 12.33; 95% CI 1.63 to 93.35).
Nature Medicine
A Nature Medicine paper published January 13, 2025, tested preoperative plasma from 171 TRACERx patients and detected ctDNA in 76 of 94 lung adenocarcinomas (81%), including 16 of 28 with stage I adenocarcinoma, and in 77 of 77 non-adenocarcinoma non-small cell lung cancers.
Nature Medicine
On June 12, 2026, the FDA approved capivasertib with abiraterone and prednisone for PTEN-deficient metastatic androgen-pathway-naive or -sensitive prostate cancer, and approved the VENTANA PTEN (SP218) RxDx Assay, which calls PTEN deficiency when at least 90% of viable malignant cells have no specific cytoplasmic staining; in CAPItello-281 (1,012 patients) median radiographic progression-free survival was 33.2 versus 25.7 months (HR 0.81), and overall survival was immature.
U.S. FDA
The FDA companion-diagnostic list dated May 27, 2026 includes FoundationOne CDx (P170019/S060) and FoundationOne Liquid CDx (P190032/S029) to identify homologous-recombination-repair gene alterations for talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer.
U.S. FDA
At the NCCN 2026 Annual Conference, faculty reported that ADT plus niraparib and abiraterone is listed for BRCA2-mutated metastatic androgen-pathway-sensitive prostate cancer, as useful in certain circumstances for high-volume disease and as a category 2B option for low-volume disease.
The ASCO Post
The NCCN 2026 prostate cancer update presented at the NCCN Annual Conference adds a table of FDA-cleared PET imaging tracer studies, in a discussion that noted prior registration trials used conventional imaging rather than PSMA PET.
The ASCO Post
The 2026 NCCN kidney cancer discussion added a recommendation, for non-clear-cell renal cell carcinoma, to consider tumor genomic testing for clinical-trial eligibility.
The ASCO Post
On May 11, 2026, the FDA approved the Atellica IM free PSA II assay to measure free PSA with a total PSA assay in men 50 years and older whose total PSA is 4 to 10 ng/mL and whose digital rectal exam is not suspicious for cancer, as an aid in distinguishing prostate cancer from benign prostatic disease.
U.S. FDA
The ESMO clinical practice guideline on advanced and metastatic prostate cancer, approved by the ESMO Guidelines Committee in January 2026, recommends genomic testing for BRCA1, BRCA2, CDK12, and PALB2 in all patients with castration-resistant prostate cancer, ideally before the first treatment for metastatic CRPC.
Annals of Oncology