NEW YORK – Fulgent Genetics is developing two SARS-CoV-2 tests for use in the US, one based on reverse-transcription PCR (RT-PCR) and another based on next-generation sequencing with PCR genome amplification.
On a Tuesday conference call recapping the firm's Q4 earnings, CEO Ming Hsieh said the NGS test for the virus that causes COVID-19 would have better sensitivity than early PCR-based tests, which showed low sensitivity. Many RT-PCR tests to diagnose COVID-19 have been developed; however, their sensitivity and specificity remain unclear. The World Health Organization did not directly respond to questions about the sensitivity and specificity of its test. The US Centers for Disease Control did not immediately respond to request for comment.
Fulgent has submitted an Emergency Use Authorization for its RT-PCR-based test to the US Food and Drug Administration, officials said, and the firm will submit its NGS test, dubbed Kiloplex PCR Plus NGS, "in the next few weeks," Hsieh said.
Hsieh noted that the firm's joint venture in China, Fujian Fujun Gene Biotech, has been validating the Kiloplex coronavirus test and said the firm's presence in that country helped position it to develop accurate tests.
Fulgent joins dozens of molecular diagnostic testing companies worldwide who have developed or begun development of tests for the virus. Chinese researchers sequenced the virus' genome in January and since then, researchers have obtained viral RNA genomes using several platforms from sequencing vendors, including Illumina and Oxford Nanopore Technologies.
Fulgent, based in Temple City, California, has been developing clinical NGS tests for applications including rare disease, prenatal testing, cancer, and cardiovascular disease. It also offers sequencing as a service for pharmaceutical companies.
Hsieh told investors the firm's experience with NGS and assay development "make us particularly well-positioned to develop tests that leverage the most relevant data to generate highly accurate results."
The Fulgent NGS-based coronavirus test will use thousands of PCR primers — hence the name, Kiloplex — to amplify the viral genome before preparing the sample for Illumina sequencing. Fulgent expects the NGS test to be more sensitive than RT-PCR tests, said CSO Harry Gao, because it has hundreds of targets, as opposed to one to three for RT-PCR. The NGS test can make a diagnosis "even with a very low viral load," Gao said, but noted the firm is determining the exact sensitivity.
NGS testing offers several potential advantages over RT-PCR, Gao said. With more targets, the chance of a mutation throwing off test results is lower. And because it provides the entire viral genome, including any mutations, it could help researchers understand the mortality rate and response to treatment, once they are developed (currently there are no treatments for coronavirus.)
Fulgent has provided the new technology to its joint venture, which is doing testing in China with real patient samples, Gao said. Hsieh added that he hopes the test will get regulatory approval in China, as well.
The PCR amplification takes about the same amount of time as a PCR-based coronavirus test: around 4 hours to make the library for NGS sequencing. "If you want to do full-genome sequencing to understand mutation patterns for this virus, that could take two to three days," Gao said. But the test is flexible, and sequencing to diagnose the virus could be done in a few hours.
Fulgent's RT-PCR test can detect SARS-CoV-2 from five copies in a sample, offering 95 percent sensitivity, Gao said.
"While it's too early to say whether this test kit might have an impact on our business in the coming months, we see this as a meaningful opportunity that we are working hard to address," Hsieh told investors. "Given the uncertainty of the approval process and the need to follow all applicable procedures, we cannot provide any estimate of timing or visibility on bringing the test kit to market at this time."
Hsieh also told investors that Fulgent's joint venture in China with Xilong Scientific and Fuzhou Jinqiang Investment Partnership posted revenue of $4.1 million in 2019, an increase of 223 percent from 2018, and the firm's portion of the loss was less than $200,000 in Q4. Officials later noted that Fulgent holds a 30 percent stake and that revenues attributable to the JV are not reflected in its top-line numbers.
Fulgent is also seeking to make an acquisition, CFO Paul Kim told investors. The company ended the year with $12 million in cash and cash equivalents and $58.3 million in marketable securities.