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The company has previously offered its liquid biopsy tests through an LDT model but sees the timing and the clinical niche as right for a regulatory bid in CSF testing.
The firm's fourth quarter revenues included $18.3 million in commercial test revenue, of which $17.6 million was attributable to COVID-19 tests.
The company highlighted efforts to expand the use of its tests in the analysis of cerebrospinal fluid, an area in which research collaborations have begun to yield some data.
The firm anticipates soon receiving FDA clearance for future products, including an AI-based prostate cancer detection system that received CE marking in 2019.
Lexent's technology integrates low-pass whole-genome sequencing, fragmentomics, and DNA methylation to detect early stage disease.
The company plans to outlicense the assay, developed using a custom Affymetrix microarray, to an interested partner.
The firm has launched a yearly subscription program that includes quarterly blood tests to look for genetic and proteomic signs of metastasis or cancer recurrence.
Investigators will compare results using Biocept's platform in cerebrospinal fluid to current standard methods for diagnosing leptomeningeal metastases.