Fulgent Genetics, Inc. (Temple City, CA, USA), a provider of comprehensive genetic testing and Next Generation Sequencing (NGS) solutions, has launched a NGS-based test for the coronavirus disease (COVID-19). Fulgent’s NGS test will be one of the market’s first diagnostic tests for the COVID-19 virus that has been developed based on NGS technology. Fulgent will partner with MedScan Laboratory (Williston, ND, USA) to launch the COVID-19 test and both have begun accepting specimens for testing from healthcare providers, clinics and reference labs.
Fulgent focuses on offering comprehensive genetic testing to provide physicians with clinically actionable diagnostic information they can use to improve the quality of patient care. The company has developed a proprietary technology platform that integrates sophisticated data comparison and suppression algorithms, adaptive learning software, advanced genetic diagnostics tools and integrated laboratory processes. This platform allows the company to offer a broad and flexible test menu and continually expand and improve its proprietary genetic reference library, while maintaining high accuracy and competitive turnaround times. The company’s current test menu includes approximately 18,000 single-gene tests and more than 850 pre-established, multi-gene, disease-specific panels, enabling it to provide expansive options for test customization and clinically actionable results.
Fulgent’s COVID-19 test is built on advanced NGS technology and will be more comprehensive than Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) tests on the market. Fulgent’s test will sequence the entire viral genome, creating hundreds of targets versus just a few for RT-PCR tests. In addition, Fulgent’s test will not be limited by a shortage of reagents, which has proven to be a roadblock for large scale processing of RT-PCR based tests in the market currently. Fulgent estimates that its lab will have capacity to process thousands of samples per day. MedScan, a CLIA certified lab, will collect samples on behalf of Fulgent and extract RNA for processing. Fulgent will sequence the viral genome, analyze samples and provide comprehensive reports back to healthcare providers.
Fulgent is uniquely well-positioned to develop and offer a NGS- based test for COVID-19 given the company’s presence on the ground in China through its joint venture, which has provided access to real positive controls and unique data insights from patients in China. Fulgent’s joint venture in China recently executed a research agreement for COVID-19 with the Chinese Academy of Medical Sciences and Peking Union Medical College Hospital (PUMCH), both for diagnostic and mutation analysis of the virus. Fulgent, through its China JV and with strong cooperation with PUMCH, began collecting patient samples beginning January of 2020 from the most affected regions of China for research, development, analysis, testing, and validation. Leveraging Fulgent’s NGS-based test, a large-scale study on these samples is ongoing to better understand how the virus sequence changes over time, and the association of virus mutations with clinical outcomes. The data may also help to predict pathogenicity and infectivity to assist in future drug or vaccine development.
“The surge in cases of COVID-19 in the US and around the world has created an urgent need for accurate diagnostic testing solutions for the viral disease,” said Dr. Harry Gao, Chief Scientific Officer at Fulgent Genetics. “We believe our NGS-based test for COVID-19 will arm healthcare providers with a better solution for accurately diagnosing cases of the disease. In addition, the virus mutation data we collect from this NGS based test could be extremely valuable to researchers in the future to predict the clinical outcome and potentially develop treatment options and vaccines for this virus.”