This new assay expands the company's COVID-19 testing program, which began in June 2020 and has now received more than 670,000 samples for processing.
Biocept's combined COVID-19 and influenza testing uses a sensitive and specific RT-PCR platform to detect and distinguish between SARS-CoV-2 and influenza.
Samples are collected through nasal swab and processed through Biocept's CLIA-certified, CAP-accredited laboratory with results typically within approximately 48 hours from receipt of sample, providing timely and accurate results.
While Biocept continues to expand and perform COVID-19 testing services with Thermo Fisher Scientific's diagnostic platform and kits, which are FDA approved, commercialization of the co-developed AEGEA Biotechnologies COVID-19 assay will be delayed, as a result of newly announced changes to FDA requirements for laboratory-developed COVID-19 tests.
Biocept, Inc. develops and commercializes molecular diagnostic assays that provide physicians with clinically actionable information to aid in the diagnosis, treatment and monitoring of patients with cancer.
In addition to its broad portfolio of blood-based liquid biopsy tests, the company has developed the CNSide cerebrospinal fluid assay, designed to diagnose cancer that has metastasized to the central nervous system.
Biocept also is leveraging its molecular diagnostic capabilities to offer nationwide RT-PCR-based COVID-19 testing and services to support public health efforts during this unprecedented pandemic.
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