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BGI Genomics Sees Diagnostics Core Business Rebounding, Overseas Business Growing

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NEW YORK – BGI Genomics has seen growth in several areas of its core diagnostic testing business during the first half of 2021 and is working on upgrading its tests in reproductive health.

Late last month, the publicly traded clinical genetic testing and research services arm of China's BGI Group reported that total revenues in H1 declined due to decreasing demand for COVID-19 testing, while its cancer prevention and control, reproductive health including its flagship NIFTY noninvasive prenatal test, and infection prevention and control businesses grew.

Li Ning, VP of BGI Group, said the regular business is "healthy" even as COVID testing demand is declining. He noted that the four biggest non-COVID drivers of revenue for the six-month period were cancer testing, infection prevention, reproductive health, and overseas growth.

The NIFTY test, which was launched in 2014 after approval from China's National Medical Products Administration, has been distributed in more than 60 countries, and more than 9.4 million tests have been performed in total, Li said.

Beyond NIFTY, BGI has other reproductive health tests that it's working to upgrade. The company has upgraded the algorithm used in its carrier screening test to expand the coverage of diseases it can detect and to add services like safe medication guidance.

The firm has also launched a multicenter genetic disease screening research project in China using its high-throughput sequencing technology to offer genetic testing for a variety of diseases and establish a genetic screening system for newborns.

Meantime, BGI Genomics has improved the coverage of its neonatal hearing loss screening test, Li said.

He also said that tandem mass spectrometry for neonatal disease screening is worth exploring, noting that "the application of tandem mass spectrometry technology in the screening of neonatal genetic and metabolic diseases has not been widely used in China." Li didn't specify what tests or applications BGI Genomics is exploring using the tech, however.

BGI Genomics' overseas business is also growing. The company has several localized in vitro diagnostic manufacturing centers globally and has received regulatory clearance for its products in a range of countries, including CE marks for its thalassemia, lung cancer, and intestinal cancer tests, Li said.

The firm's most important region in terms of business value outside of China is the rest of Asia, including Hong Kong, Macao, and Taiwan, along with Oceania. The biggest growth in the first half of 2021 occurred in the Americas, with revenues up 47 percent, and in Europe and Africa, where revenues grew nearly 25 percent.

Even though demand isn't as strong as in 2020, BGI Genomics isn't done with COVID-19 testing. Along with developing and launching its COVID-19 tests, the firm has built mobile laboratories, called Huo-Yan labs, across the world to provide rapid SARS-CoV-2 testing in regions where testing is limited. The labs are located in a variety of settings, including airports, and are a way "to export testing technology and equipment" to areas where it's needed most, Li said.

The COVID testing labs are mounted on either a vehicle or trailer platform and can be built and moved quickly, he said. Most of the Huo-Yan labs are operated by local public health departments or local authorities, although some have been commissioned by BGI, he added. BGI Genomics provides the training and technical support services for the lab, but the actual testing program is determined by the public health department, he said.

They largely perform PCR testing, with a small amount of antigen testing, and mostly use SARS-CoV-2 tests developed by BGI, according to Li. Those tests include virus sequencing assays; nucleic acid detection assays; rapid nucleic acid, antibody, and antigen tests; and neutralizing antibody assays; as well as multiplex assays for SARS-CoV-2 and influenza, he said.

So far, more than 90 Huo-Yan labs have been established in 30 countries with a maximum daily testing capacity of 1 million tests, Li said.

He added that BGI is ready to work with local authorities to expand the diseases and pathogens being tested for in these labs, although he noted that it's up to the authorities what those expansions look like. "The transformation of BGI's COVID-19 testing [business] into regular business has begun to take shape," Li said.

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