NEW YORK (GenomeWeb) – Startup Cirina has raised $12 million in a Series A financing round to support development of noninvasive screening tests for early detection of cancer and other diseases.
Dennis Lo, director of the Li Ka Shing Institute of Health Sciences at the Chinese University of Hong Kong, founded Cirina in 2014 and has tapped Maneesh Jain to serve as the company's CEO. Jain previously served as vice president of marketing and business development at Life Technologies' Ion Torrent before it was purchased by Thermo Fisher Scientific and most recently as COO of medical imaging startup Butterfly Network. Min Cui, managing director of Decheng Capital, led the Series A financing round.
Jain told GenomeWeb that Cirina plans to use technology developed by Lo to detect and analyze circulating cell-free DNA to develop tests for the early detection of cancer and other diseases, like autoimmune disorders.
He declined to disclose specifics about the technology, and said that the company would look to employ next-generation sequencing, PCR, and/or microarray-based testing, choosing whichever technology made sense.
Cirina recently moved into a 10,000-square-foot facility in South San Francisco, California and over the last year has been recruiting additional employees. Jain said Cirina plans to launch its first test as early as 2017 in either the US or Asia. "We want to move fast but also be quite thoughtful about the different opportunities," he said. "We are exploring various options to see what makes sense and looking at different disease areas to see where we can make the biggest impact."
He said the company is already conducting clinical trials in both the US and Asia with partners that involve "thousands of samples" and expects to publish some results next year.
Jain said that the company will develop tests for specific indications, as opposed to a pan-cancer test. In addition, he said that Cirina will focus solely on early detection, rather than tumor profiling or monitoring.
The firm plans to develop noninvasive tests that analyze copy number variants, SNVs, and even methylation, Jain said, although the alterations analyzed and technology used to analyze those alterations would likely vary depending on the indication, Jain said.
Cirina is looking to differentiate itself from established companies in the liquid biopsy space like Foundation Medicine and Guardant Health, which are developing noninvasive tests as a means to profile tumors, select an appropriate therapy, and monitor disease recurrence or response to therapy. "We don't think of ourselves as a liquid biopsy company," Jain said. The term liquid biopsy implies an assay that is replacing a tissue-based biopsy, but Cirina plans to focus on screening for early detection, before tissue biopsies are even performed. In addition, Jain said, "the approaches you use for [liquid biopsy] applications are very different than for early detection. And it's not that easy to move from the one area to the other."
Another competitor will likely be Illumina's Grail, which launched early this year and is also developing an early cancer detection test that will analyze circulating tumor DNA. Grail has said it plans to begin clinical trials in 2017 and will launch an assay in 2019 for $1,000 or less. The main difference is that Grail is looking to develop a pan-cancer NGS-based test, while Cirina is developing different assays for different indications and is technology agnostic.
With early noninvasive detection of cancer, one concern has been that even if a test can detect circulating tumor DNA, it may not be able to pinpoint where in the body a tumor is growing. Jain said that this is a challenge the company has already made progress on. Last year, for instance, researchers from Lo's laboratory at the Chinese University of Hong Kong published a study in the Proceedings of the National Academy of Sciences indicating that cell-free DNA could be traced back to its tissue of origin by looking at methylation markers.
This summer, Lo and the Chinese University of Hong Kong secured US Patent No., 9,371,566 describing a method to use DNA methylation as a means to detect cancer from plasma, blood, serum, saliva, or urine.
While Lo is best known for developing the whole-genome shotgun sequencing approach originally commercialized by Sequenom to noninvasively detect fetal chromosomal abnormalities, his lab has also been investigating new methods for analyzing cell-free DNA for other applications, including looking at methylation and even size differences in cell-free DNA, to serve as useful markers for either cancer or transplantation applications.
Jain said that for cancer, the early detection tests would initially be designed for individuals at high risk of developing the disease. For instance, he said, today those classified as high risk for lung cancer based on smoking history and age are screened via low-dose CT scans, which have a high false positive rate. Cirina's ctDNA screening test could improve on these scans.
Jain said the company is also keeping its eye on the regulatory environment, adding that it would likely commercialize a laboratory-developed test before bringing it through US Food and Drug Administration clearance. Launching as an LDT enables "a certain amount of clinical adoption and validation by external thought leaders," which can help support an in vitro diagnostic approval.