NEW YORK – Fulgent Genetics announced Tuesday a partnership with MedScan Laboratory to test for SARS-CoV-2, the virus that causes COVID-19, using next-generation sequencing.
MedScan will collect patient samples for Fulgent and extract RNA at its CLIA-certified lab in Williston, North Dakota. Fulgent, based in Temple City, California, will sequence the viral genome, analyze samples, and provide reports to clinicians.
The firms said they would begin accepting samples from clinics, reference labs, and healthcare providers this week.
"We believe our NGS-based test for COVID-19 will arm healthcare providers with a better solution for accurately diagnosing cases of the disease," Fulgent CSO Harry Gao said in a statement. "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."
Fulgent is developing the NGS-based test with Fujian Fujun Gene Biotech, the firm's joint venture in China, which has provided access to positive controls since January. Fulgent said in a statement that the joint venture recently entered into a research agreement on Covid-19 with the Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, for diagnostic testing and analysis of SARS-CoV-2.
Fulgent plans to submit the test to the US Food and Drug Administration for emergency use authorization in "the coming weeks," the firm said.
Fulgent is also developing a reverse transcription PCR-based test for COVID-19.