GenapSys said today it is pursuing a partnership with Chinese health authorities to use its portable sequencer for detecting 2019-nCoV novel coronavirus, as part of the company’s launch of its instrument in the Asia-Pacific region.

“We were approached in late January by the Chinese CDC to help address the outbreak,” GenapSys CEO and founder Hesaam Esfandyarpour, PhD, told GEN Edge. “We are, basically, currently in talks with them to discuss the details of how we will be sending our next-gen sequencer to support the effort on the ground with the CDC officials.”

Chinese authorities connected with GenapSys in late January by contacting one of the company’s distributors. The company has signed agreements with more than 25 distributors set to market the sequencer in more than 30 countries, including Singapore-based Research Instruments, Biomedical Systems of South Korea, and Hong-Kong based Gene Company.

In addition to China’s GenapSys’ Asia-Pacific rollout will include Japan, South Korea, and Singapore. The Asia-Pacific launch is among purposes for which the company has raised $75 million in new financing. Oxford Finance led the new financing, which brings the company’s total capital raised to more than $200 million.

“We were planning to launch in Asia-Pacific anyhow, but this whole unfortunate outbreak of the coronavirus created extra need for a decentralized, accurate platform like the GenapSys sequencer,” Esfandyarpour said.

According to the World Health Organization data reported Wednesday, 24,554 confirmed cases of 2019-nCoV coronavirus have been reported to authorities, of which 99% (24,363) cases were in China. All but one of the 492 confirmed patient deaths have taken place in China.

The number of confirmed cases has jumped 68% from 14,557 on Sunday, while deaths have risen 61% from 305 worldwide (304 in China). GEN’s ongoing coverage of the 2019-nCoV novel coronavirus outbreak has also reported on two recent studies that have linked nCoV-2019 to bats, as well as an artificial intelligence-based prediction model for antiviral drugs that may be effective on novel coronavirus.

“More than 1,000 leads”

GenapSys officially launched and started shipping its sequencer in the U.S. during the fourth quarter, after announcing the product launch at the American Society of Human Genetics (ASHG) 2019 Annual Meeting, held October 15–19 in Houston.

“We are already basically receiving a great amount of interest worldwide. More than a thousand leads have been already showing a strong interest in these sequencers,” Esfandyarpour said. Privately-held GenapSys will not disclose how many sequencers it has sold, or customers that have bought the instruments.

The GenapSys Sequencer is about the size of an iPad, costs under $10,000—consumables cost $299—and is based on a proprietary direct electronic sequencing chip, which is intended to eliminate the need for cumbersome equipment.

As a result, GenapSys says, the sequencer can be used in a variety of settings that include hospital labs, public transportation hubs,and airports—with applications that go beyond infectious disease, to cancer research, food science, forensics, personalized medicine, and other scientific and medical fields.

GenapSys carries out sequencing on microfluidic chips that have a scalable number of detectors, designed to allow for applications ranging from targeted sequencing of specific amplicons to genome-scale data collection. The system uses what the company says is the first ever purely electrical sequencing chip, the key component in its fully integrated proprietary platform.

The company’s next-generation sequencing technology uses its own sequencing-by-synthesis chemistry that employs electrical-based detection of single nucleotide incorporations—as well as complementary metal oxide semiconductor (CMOS)-based detectors, simple fluidics, and no moving parts. GenapSys says its sequencer routinely generates sequence data that exceeds >80% of bases >Q30 with average read lengths of >150 bp.

Signature discovery

The use of electrical sequencing applies Esfandyarpour’s knowledge and training as an electrical engineer. In an interview during the recent J.P. Morgan 38th Healthcare Conference in San Francisco, Esfandyarpour recalled how he switched the focus of his research and work from wireless communications applications, such as improving cell phone signals and chips, to DNA sequencing after a family member was misdiagnosed with illness at a very young age.

“Historically, biologists were using effectively optical systems, microscopes and cameras, and trying to automate those. I am coming from an electronic background, looking at the optical systems, all the big, bulky, expensive machines and rollers and scanner and camera and laser and whatnot. And the idea came to mind: Why not measure the electrical signature of the reaction using a semiconductor, electronic chip?” Esfandyarpour said.

Esfandyarpour and colleagues developed novel technologies for DNA sequencing and protein detection at Stanford Genome Technology Center, where he brought his ideas to the center’s director, Ronald W. Davis, PhD. The pioneer geneticist co-developed the first DNA microarray for gene expression profiling and the gene expression profile of the first complete eukaryotic genome, after completing postdoctoral studies under Nobel Laureate James D. Watson, PhD.

“He told me that, ‘If you can build these, you are going to build a PC in the world of mainframes when it comes to sequencing,’ because the legacy technology looked like mainframe computers, if you want to use a metaphor of the computer industry,” Esfandyarpour said of Davis. “He convinced me I should work on it as my PhD project, and I made the change from radar to DNA back in 2004.”

Among hurdles Esfandyarpour encountered toward developing his sequencer was the fact its original technology, a quasi-electronic technology based on pH measurement, still required a nitrogen or argon tank and a large server next to the platform, because of the need for measuring transient signals.

“The aha moment,” Esfandyarpour recalled, “was when we learned that DNA molecules were actually the highest charged molecules in nature, and we can actually detect additional bases that add to the molecule in a steady-state measurement via impedance detection—direct electronic measurement, which is very different than any of the legacy technologies.”

Scalable sequencing

GenapSys plans this year to launch its 144 million sensor chip, designed for applications that include sequencing a whole human exome or genome. [GenapSys]
GenapSys’ sequencers offer a built-in capability to scale up from 1 million to 16 million to 144 million sensors, with the 144 million sensor chip set to be launched this year.

The 1 million sensor chip is usable in applications involving small numbers of samples, such as food testing applications, testing for cancer using panels of a few genes, as well as for microbiome or small genome applications.

“If you suddenly have 40 patients, or 96 patients with single-gene amplicon-based assays, then you use a 16-million sensor.  If you have a more comprehensive, larger-scale cancer panel, then you use a 16-million sensor or 144-million sensor.  If you have a whole human exome or genome, you use a large chip, the 144 million,” Esfandyarpour explained.

The 16 million sensor chip can generate 1.2-2.0 Gb of high-quality sequence data with average read lengths of >150 bp, according to the company.

In addition to developing its technology, GenapSys has also moved to strengthen its management and advisory teams. GenapSys’ board includes executive board member Frank Witney, PhD, former president and CEO of Affymetrix before its acquisition by Thermo Fisher Scientific, as well as Rakesh Sachdev, former CEO and president of Sigma-Aldrich until its purchase by Merck KGaA; he is now CEO of Platform Specialty Products.

GenapSys’ scientific advisory board includes Davis as well as George Church, PhD, of Harvard Medical School; and Eric Topol, MD, director of Scripps Translational Science Institute.

Headquartered in Redwood City, CA, GenapSys raised its latest financing just three months after it completed a $90 million Series C round led by Foresight Capital, with proceeds intended to fund commercialization of the sequencer, grow the company’s interdisciplinary team, and continue innovation efforts.

“The current, expensive, large systems costing half-a-million-dollars or $1 million, the number of labs that can afford or can own that are very limited.  We have a very small number of large labs that today have sequencers, and most people have to send their samples there,” Esfandyarpour noted.

“We believe in a world that every researcher or clinician can have a DNA sequencer and have the power of genomics and control of their sample in their own hand.  And that is a very different expansion and capacity of bringing the capability of genomics in our lives,” Esfandyarpour added. “What we have done at GenapSys is effectively that enabling tool to enable that high-accuracy, high-quality yet affordable and accessible genomics.”

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