The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
The assay provides comprehensive genomic information to oncologists from a blood draw, using targeted next-generation sequencing of circulating cell-free DNA.
The company is employing Guardant360 in a Phase III trial assessing the efficacy of the drug both in a larger population and in women who test positive for ESR1 mutations.
The test detects the HER2 biomarker in breast cancer and can be completed within the same day, allowing for faster results than other HER2 testing methods.
The company expects to garner clearance for its platform in the US first for Lynch syndrome as it builds additional evidence for an immunotherapy application.
The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
The firm expects to launch a tissue-based immunohistochemistry version of the test, which detects QSOX1, in mid-2021, followed by a dipstick plasma-based assay by early 2022.
The DXRX marketplace, planned for launch in the fourth quarter of 2020, will provide a way for pharmaceutical companies, diagnostic firms, and laboratories to collaborate.
The startup is developing a qPCR-based profiling method that could provide results within hours to clinicians treating their cancer patients with immune checkpoint inhibitors.
