Guardant Health Receives FDA Emergency Use Authorization for its Guardant-19 Next Generation Sequencing-Based COVID-19 Test
The Guardant-19 test is a reverse transcriptase polymerase chain reaction next generation sequencing (rt-PCR-seq) test that detects coronavirus SARS-CoV-2 nucleic acid from upper respiratory nasal specimens including nasopharyngeal swabs, oropharyngeal swabs, nasal swabs, interior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal wash/aspirates, nasal aspirates, and nasal washes. The test has a validated limit of detection (LoD) of 125 copies per mL and results are typically returned the next day. The heavily multiplexed testing workflow used has the ability to scale to over 10,000 tests per day.
“While serving cancer patients remains our top priority, we are proud to be able to leverage our expertise in liquid biopsy testing to contribute to battling the COVID-19 pandemic by offering a highly accurate test that is truly additive to the testing options available today,” said AmirAli Talasaz,
The Guardant-19 test is being used to help
“Our mission is to permanently and safely reopen schools, business and the US economy by providing affordable, accessible and frequent testing and screening. We believe that a testing option like the one provided by
To learn more about accessing the Guardant-19 test, email: firstname.lastname@example.org.
About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets, and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360® and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.
Source: Guardant Health, Inc.