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Singlera to Use $60M Funding to Support Launch of IVDs, Research Into Very Early Detection of Cancer

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NEW YORK (GenomeWeb) – Singlera Genomics expects its recent $60 million in venture funding will enable it to soon develop a revenue stream in the US and China, while also progressing it toward its goal of identifying patients at risk for cancer even before a formal diagnosis can be made, according to the company's Chairman Yuan Gao.

In an interview, Gao said that Singlera is carving out a research niche in the heavily funded market of early cancer detection, which includes companies such as Grail, Guardant Health, and Caris Life Sciences. The foundation to distinguish Singlera from potential competitors lies in its study of 200,000 healthy individuals begun in 2008, which after 10 years, has found that about 1,000, or 5 percent, of the subjects have developed cancer.

By the end of the year Singlera expects to publish the results of the study, which was conducted with the Taizhou Health Science Institute of Fudan University. The study, said Gao, a former IBM executive, complements Singlera's work to develop in vitro diagnostics and his informatics background.

"Without a long-term patient study, bioinformatics and a wet lab, how can a company develop tests for the early detection of cancer?" Gao asked rhetorically.

The crux of Singlera's technology is a method for determining the origins of circulating DNA fragments that its developers said could be used to more sensitively detect cancer. The method relies on identifying methylation haplotypes that are specific to a particular tissue or cell type, and was described in a study published last year in Nature Genetics.

According to Gao, the commercial implications of Singlera's early detection testing are broad, and he noted that Singlera and its investors expect its products to generate revenue from their use in hospitals in China during the next two years. The company also is in negotiations with an undisclosed top-three diagnostic company to license out a second-generation noninvasive prenatal test that it codeveloped with Yale University. 

In the US, investors want companies to demonstrate progress in the development of their products and technology, which could serve as benchmarks for additional funding, Gao said. In contrast, Chinese investors want portfolio companies also to demonstrate steady revenue growth from its products, partly because a company cannot go public in China without three years of revenue. 

To that goal, Singlera has placed its diagnostic platform and assays in five of the top 10 hospitals in China for reseach use only. While the assays are now being tested in the hospitals, Gao expects them to eventually buy Singlera's hardware and software system once they are approved by Chinese regulators. Singlera has contracted with an OEM company to build a diagnostic device that includes Singlera's next-generation sequencing technology, but the company has yet to release the specifications of the device. The device, along with Singlera's assays, would be purchased by Chinese hospitals as a single unit, Gao said, and Singlera can sell the assays for use with other sequencing platforms, once they are approved by regulators.

Similarly, the company's NGS-based NIPT is ready for commercialization. Codeveloped with Singlera Cofounder and University of California, San Diego bioengineering professor Kun Zhang, the test detects chromosomal aneuploidy and measures fetal DNA fractionation. According to Singlera, it can reliably estimate the fetal DNA fraction for both male and female fetuses and can detect chromosomal abnormalities in one test.

In a field that is becoming increasingly crowded — Laboratory Corporation of America's Sequenom, Roche's Ariosa Diagnostics, Illumina's Verinata Health, and Natera are among the major players — Yale and Singlera contend that their NIPT test has a turnaround time of one to two days, which Singlera believes would provide it a distinct advantage. While other NIPT firms have developed or are developing kits that have quick turnaround times, Singlera is positioning its test to eventually be sold to hospitals and local laboratories in North America and Europe, said Gao, similar to its market strategy in China. The introduction of the test in Europe and the US, either as a complete system or a kit, will depend on the partnership Singlera strikes with its international partner.

Singlera is positioning its test for a direct sale to hospital and local laboratories, said Gao, similar to its market strategy in China. Singlera's NIPT looks only at the three most important genetic chromosomes in fetal testing – chromosomes 21, 18, 13. 

While Natera and Ariosa have similar technologies to Singlera, he said that Singlera expects to differentiate itself with its speed of diagnosis and by selling a complete system to individual labs and hospitals. Other NIPT firms, Gao said, have an average turnaround time of up to one week.

The NIPT test, along with assays for screening for BRCA1/2 mutations, lung cancer, and multigene cancer mutations can be sold as standalone tests, and Singlera plans to generate revenues by placing them in China and the US, Gao said.

As it builds up its revenue pipeline, the company remains focused on its goal of being a pioneer in early cancer detection, Gao said. The investors who placed the $60 million Series A+ financing round have more of a longer-term vision than many other Chinese venture capitalists, he noted, and provided the funds with the understanding that Singlera's research needs sustained funding.

He said that after Singlera publishes the results of its 10-year study with Fudan University, it likely would start development of an early cancer detection assay next year based on the data from the 200,000 patients. The company initially will develop the assay for use in blood, but expects it can be used in urine, as well.

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