Natera has unveiled data that shows the efficacy of its molecular residual disease (MRD) test in detecting Merkel cell carcinoma, a type of aggressive skin cancer.
The results, published in the Journal of Clinical Oncology, demonstrated that the test – named Signatera – had a sensitivity of around 95%. This measures how well a test can identify tumour cells at the time of enrollment.
Natera evaluated the technology in a prospective, multi-centre, observational study that included 319 patients with stage I-IV Merkel cell carcinoma. Signatera was used to assess ctDNA levels at the time of enrollment, and then every three months during the surveillance period. The test is currently available worldwide for clinical and research use.
MRD tests look for small amounts of cancer that fragment off the tumour, known as circulating tumour DNA (ctDNA).
Natera said its test showing ctDNA positivity was associated with 20 times higher of recurrence than patients with persistent absence of ctDNA. This information is important to the therapy regimens of patients with cancer and seeing how well they are working in treating the cancer.
The study’s lead author Lisa Zaba said: “Our study shows that a tumour-informed MRD test can inform prognosis and guide surveillance in patients with MCC, regardless of tumour viral status.”
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After a year of surveillance, positive ctDNA patients had a recurrence-free probability of 9%. This compared to 91% of patients who remained ctDNA negative.
The positive results mean the personalised test can help patients with Merkel cell carcinoma which has a recurrence rate of 40% within five years.
The National Comprehensive Cancer Network recommends viral antibody-based MRD testing, but Natera says this tumour marker is only present in around half of Merkel cell carcinoma cases and has limitations.
Natera’s senior medical director and study co-author Angel Rodriguez said: “We are optimistic that Signatera will become a standard monitoring tool in this highly lethal cancer type, enabling clinicians to select patients with MRD who might benefit most from adjuvant therapy and better determine who may or may not need more frequent imaging with a high degree of confidence.”
The MRD testing market is expected to reach $4.1bn by 2032, according to analysis by GlobalData. The sector is growing rapidly due to advancements in drug development technologies and a growing emphasis on personalised healthcare.
Analysis indicates that MRD testing is becoming a key tool in assessing treatment response and guiding therapeutic decisions in oncology.