TEST:

Follow It®

A population of Canadian women with metastatic breast cancer were tested using a liquid biopsy gene panel during the COVID-19 pandemic for identification of biomarkers for targeted therapeutic options. Over 50% of the samples were identified as hormone positive, with greater than 60% harboring PIK3CA and ESR1 ctDNA mutations. Studies have shown that metastatic PIK3CA mutated ER-positive/HER2-negative tumors are predictive to respond to alpelisib therapy and have FDA and Health Canada approval.

By combining multiple types of molecular analyses, it was uncovered that this patient was eligible for novel clinical trials containing MEK and PD-L1 checkpoint inhibitors. Digital tools for genomic interpretation, clinical trials matching, and molecular tumor board discussions not only provided clinical decision support but also accelerated the path to treatment options.

P=N/A; Not yet recruiting --> Recruiting | Initiation date: Mar 2022 --> Jul 2022

P=N/A; Not yet recruiting --> Recruiting | Initiation date: Oct 2021 --> Jun 2022

"Protean BioDiagnostics to present on embryonal rhabdomyosarcoma in a pediatric patient...Combining immunohistochemistry, OncoTargets pathway analysis that measures key signaling pathway activity, Follow It liquid biopsy, and structural chromosome aberration analysis by copy number variation uncovered that this patient was eligible for a novel clinical trial containing MEK and PD-L1 checkpoint inhibitors."

The analyses revealed important takeaways: 1) key activating mutations can be identified using a simple liquid biopsy, 2) some embryonal RMS cases have PD-L1 expression, and 3) OncoSignal analysis may be useful in identifying oncogenic driver pathways. These findings helped to identify that this child was eligible for a clinical trial that contained combined MEK and PD-L1 checkpoint inhibitors, a potential solution to treating embryonal RMS.

P=N/A; N=10; Not yet recruiting; Sponsor:British Columbia Cancer Agency

Median time from referral to treatment initiation was 31 days (range 16-41) if an actionable alteration was identified in plasma versus 35 days if none was identified (range 20-58).Conclusion While liquid biopsy in the initial diagnostic workup of advanced NSCLC patients may accelerate profiling Result s and treatment initiation, comprehensive NGS assays with faster TAT are needed. An expansion study (N=150) is ongoing with a comprehensive DNA-based assay with faster TAT (SNV, indels, fusions, CNV; InVisionFirst, Inivata).