NEW YORK (GenomeWeb) – With its Mini8 portable PCR system being adopted to test travelers in various airports in China, Coyote Bioscience has begun to expand, opening a new facility in California. The company also is developing a menu of molecular diagnostic tests for the system and is planning a 2017 launch of a digital PCR instrument suitable for point-of-care use.
Coyote was founded in Beijing in 2009 with a grant from the Chinese government, founder Sabrina Li told GenomeWeb in an email. The firm's vision was to create readily available diagnostics through "portable, easy to use instruments and a one-step reagent that requires no nucleic acid extraction or sample preparation," Li said.
The firm initially began by developing instruments for controlling temperature, which then evolved into its first portable PCR instrument with endpoint detection. Since then, Coyote has developed and launched its real-time PCR instrument, the Mini 8, which is also portable.
Mini8 is an open system with two detection channels that runs on a 12-volt battery with a laptop interface. It weighs less than five pounds and measures eight inches long, seven-and-a-half inches wide, and a little under four inches tall.
The system can also run Coyote's proprietary "One Step" reagent, which is a PCR reagent mix that allows for direct addition of sample for PCR amplification. The reagent eliminates or reduces PCR inhibition in most clinical samples and enhances the PCR reaction for a timely result, Li said.
The Mini8 system is also available in a carrying case, in a configuration called the "One-Step MD-Box-Lab" that also transports a few commonly used additional items to enable portable molecular testing.
"The Mini8 system has been deployed throughout the world, from rural, remote areas to highly populated city hospitals," Li said.
The firm recently opened a branch near San Jose, California to facilitate expanding into the US market, Li said, as well as to take advantage of the state-of-the art technology and the talent pool in Silicon Valley. She noted that Coyote's Mini8 system currently is being sold in the United States for non-regulated markets.
But the firm also is manufacturing diagnostics tests to be used on the Mini8 that deploy the One Step reagent mix.
In 2016, a number of locations in China began using the Mini8 and a Coyote-developed Zika assay to screen travelers for the virus. The test is currently being administered to travelers coming from countries with known outbreaks who also have clinical symptoms, such as fever.
Testing was initiated at locations such as international healthcare centers in Zhejiang and Beijing, as well as the Beijing West Railway Station, Li said. Three airports also began using the testing in their "Entry-Exit Inspection and Quarantine Bureaus."
In February, the first three cases of Zika virus detected from infected travelers entering China were discovered using the Coyote Mini8 and Zika assay in the Beijing Capital International Airport. The fourth and fifth cases were found in May using the system in the Zhengzhou Xiaoshan International Airport, and Xinzheng airport used the system to discover the first case in Henan Province in September, Li said.
The Coyote Zika test "was performed at the airport from a buccal swab, blood sample, or urine sample by technicians in a quarantined area," she said, noting that a confirmatory test was subsequently performed at a centralized CLIA lab to verify Coyote's test results.
Coyote's Zika test was chosen for this mission because it was a molecular diagnostic test that was accurate and easy to use, Li said. "The Chinese government was so pleased with Coyote's Zika test that it was used in Brazil during the Olympics to monitor the Chinese athletes," she added.
The Zika test is currently being taken through the Chinese Food and Drug Administration, but Coyote has no plans at the moment to bring the test through the Emergency Use Authorization process in the US.
The firm previously developed an assay for Ebola on the Mini8, and, in collaboration with a Chinese government health agency, Coyote tested more than 500 samples in Sierra Leone to assist with humanitarian efforts during the Ebola outbreak in Africa.
The firm has also been working on a Bunyavirus diagnostic, which was used to help manage an outbreak of Bunya in an endemic area of Xinyang, China. "The outbreak management effort was funded by the Natural Science Foundation of China and the China Mega Project for Infectious Disease, [and] a total of 882 clinical samples were tested for suspected Bunya viral infections," Li noted.
Other molecular diagnostics in development at the firm include tests in the fields of women's health, pediatrics, cancer, and genetic disorders, Li said. Specifically, Coyote is developing diagnostics for Chlamydia trachomatis, Neisseria gonorrhoeae, hepatitis B and C viruses, human papillomavirus, and CYP2C9, as well as diagnostic tests for colon and lung cancer.
Coyote is also developing a digital PCR system for lab and point-of-care use, Li said.
"The design of the system is based on a simple-to-use consumable and an instrument that will process the sample to give an absolute quantitative result in an hour or less," she explained. "We believe that digital PCR is a natural evolution of PCR for applications such as rare gene detection, viral quantitation, and gene quantitation."
The instrument will have multiplexing capability through the use of five optical channels. The firm is currently planning to work with key collaborators in the United States and China at beta testing sites and expects that the instrument will be commercially available — including in the US — in 2017.
Coyote is currently generating revenue through sales of its products, and it is also funded by venture capital firms including two rounds of funding from SAIF Partners, Northern Light Ventures, and Legend Star.
"We are selling our instruments worldwide including in China, Europe, and North and South America," Li said, noting that the largest customer base, to date, has been in China.
"Customers in China include the Chinese Center for Disease Control, China Inspection and Quarantine Services, hospitals, and academic and research laboratories, [and] the Chinese CDC and CIQ have utilized our Mini8 system and One Step molecular diagnostic tests extensively, especially for emerging disease detection and emergency outbreak of infectious disease," she said. The firm also plans to set up future collaborations for cancer and infectious disease diagnostics in the United States and Europe.