Biocept OncoCEE/0099 lung profile – pro

Biocept OncoCEE/0099 lung profile test is aliquid biopsy test that putports to establish malignancy and test markers from circulating cancer cells. It includes testing for : ALKEGFRROS1METFGFR1PD-L1RETKRASBRAF.

 

  • Liquid biopsies are supported under some conditions in a recent publication of Archives of Pathology & Laboratory Medicine, Journal of Thoracic Oncology and The Journal of Molecular Diagnostics.  In some clinical  settings in which tissue is limited and/or insufficient for molecular testing, physicians may use a cell-free plasma DNA assay to identify EGFR mutations. Physicians may use cell-free plasma DNA methods to identify EGFR-T790M mutations in lung adenocarcinoma patients with progression or secondary clinical resistance to EGFR-targeted tyrosine kinase inhibitors; if the plasma result is negative, testing of the tumor sample is recommended.

The records  mentions a previous tissue biopsy and does not explain why testing for mutations cannot be performed on it. As such, there is no support to provide this testing since the scientific evidence must permit conclusion concerning the effect of the service on health outcomes

Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment with Targeted Tyrosine Kinase Inhibitors – 2018, https://www.iaslc.org/capiaslcamp-molecular-testing-guideline

Wang Z, Chen R, Wang S, et al. Quantification and dynamic monitoring of EGFR T790M in plasma cell-free DNA by digital PCR for prognosis of EGFR TKI treatment in advanced NSCLC. PLoS One. 2014;9:e110780.

Weber B, Meldgaard P, Hager H, et al. Detection of EGFR mutations in plasma and biopsies from non-small cell lung cancer patients by allele-specific PCR assays. BMC Cancer. 2014;14:294.

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