Invitae, a leading medical genetics company, announced new research published in Nature describing the first use of the company’s personalized cancer monitoring (PCM) platform to demonstrate the utility of ctDNA as a biomarker for cancer recurrence in a large cohort of patients with stage I-III non-small-cell lung cancer (NSCLC) followed for up to five years.
The research technology used in the study leverages a patient-specific panel developed to identify variants from a patient’s own tumor rather than a static gene panel. This study leveraged Invitae’s PCM platform to assess panels of up to 200 variants, a size unique to this platform at the time the study was conducted, and was optimized for maximum performance. Since then, Invitae has commercialized its laboratory developed test utilizing panel sizes of up to 50 variants. In this publication, sensitivity and specificity of >99.9% was achieved at 0.008% variant allele frequency (AF) with 60ng cfDNA input and 0.03% variant AF with 10ng cfDNA input using a 50 variant patient-specific panel.
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“The use of our PCM platform in this large study shows the value of our technology which providers can use to identify early detection of residual disease and cancer recurrence through a liquid biopsy and improve their patient’s overall cancer journey,” said Robert Daber, Ph.D. DABMG, chief science officer at Invitae. “These results validate the need for products like PCM that create a data-driven treatment process for patients and physicians alike through ongoing cancer monitoring.”
Patients enrolled in the study had plasma analyses performed before surgery and 141/197 patients (including 75 with NSCLC recurrence) had repeated postoperative plasma analyses performed with a median of six time points. Using new phylogenetic tracking technologies including patient specific anchored-multiplex PCR (AMP), these tumor-specific clonal and subclonal mutations were identified in combination with a novel tool (ECLIPSE) to extract clonal composition in the context of the low ctDNA levels in patients with recurrent NSCLC. The versatility of the AMP technology permitted the study of patient plasma samples across a range of individual panel sizes (72 to 201, median 200).
Clinical sensitivity and specificity were also assessed in this study. Clinical specificity was assessed in 61 patients without evidence of disease in whom ctDNA was not expected to be detectable. This group of 61 patients included 42 recurrence-free patients and 19 patients who were disease-free at the time the ctDNA was assessed but subsequently developed new primary cancers during follow-up.
SOURCE: PR Newswire