Brazilian and Canadian firms partner to develop innovative hepatitis C screening test

By Claudia Izique  |  FAPESP Research for Innovation – DGLab, a startup incubated at the Supera Technological Innovation Park in Ribeirão Preto, São Paulo State, Brazil, is partnering with Custom Biologics, a Canadian firm based in Toronto, for the joint development of a simple and affordable nucleic acid amplification test (NAT) to screen for viral hepatitis C.

The partners’ proposal was selected in a call issued by FAPESP and the National Research Council Canada (NRC). To implement the test, DGLab will receive funding from FAPESP under its Innovative Research in Small Business Program (PIPE), and Custom Biologics will receive funding from the Canadian International Innovation Program (CIIP).

“This partnership will enable Custom Biologics and DGLab to develop a fast, cost-effective NAT for hepatitis C using blood samples,” says Daniel Mamelak, CEO of Custom Biologics.

The two firms have complementary expertise. “DGLab has mastered the technique of blood collection on filter paper and the use of blood sample storage cards,” explains Daniel Blasioli Dentillo, a co-owner of the Brazilian startup. Custom Biologics developed and patented DASL RAPID, a precision testing technology that does not require a laboratory. “The test can be performed locally, even in areas without medical facilities,” Mamelak says.

At present, there are two main types of tests for hepatitis C, according to Mamelak. “Immunoassays are quick and inexpensive but lack the precision to support decisions on patient care. Technologies based on the polymerase chain reaction [PCR] method perform well and are very sensitive, but they take a long time and are costly,” he says.

The idea is to demonstrate, with the support of FAPESP’s PIPE program, that the NAT for hepatitis C is easier to perform, produces results in a shorter time and costs less than PCR, making the test a strong candidate for routine use in public health services.

The efficacy of the diagnostic platform will be validated with clinical samples from Adolfo Lutz Institute (IAL), according to Mamelak. “This will enable us to compare our technology with PCR, the current gold standard in testing,” he says. IAL is attached to the São Paulo State Department of Health and acts as a Central Public Health Laboratory in epidemiological, sanitary and environmental surveillance for preventing, controlling and eliminating diseases.

“We see two main markets,” Mamelak says. “In the case of IAL and other major labs, DASL RAPID enables large numbers of samples to be tested rapidly, accurately, and at far lower cost than the methods used at present.” DASL RAPID can also be used, he adds, in remote areas where technologies that require trained personnel would not be practicable.

Although the hepatitis C test under development by the two firms is based on a patent-protected novel isothermal nuclei acid amplification technology, Mamelak acknowledges that competing technologies are in the pipeline. “Nevertheless, thanks to our collaboration with DGLab in Brazil, we expect to be the first to succeed in developing a fast NAT for hepatitis C,” he says.

In Mamelak’s view, Brazil will be the world’s first market to test and validate this new technology. “We believe Custom Biologics can help DGLab to emerge as the leader in fast and affordable NATs for HCV [the virus that causes hepatitis C] and many other organisms,” he says.

Proof of concept

DGLab was conceived in 2014, when Dentillo completed his postdoctoral research at the University of São Paulo’s Ribeirão Preto Medical School (FMRP-USP) with the idea of setting up a company to develop innovations in diagnosis involving genetics. “I partnered with Dante Gavio, who had completed a PhD in the same area, and we submitted a proposal to the Supera Park incubator and FAPESP’s PIPE Phase 1 [for research to prove the project’s technical feasibility],” he recalls.

The project approved by FAPESP proposed a proof-of-concept test of a low-cost diagnostic method for hepatitis B, integrating the storage of blood collected by the patient, the transportation of samples using blood cards, and analysis to identify and quantify nucleic acids, a key viral hepatitis marker.

Completed in May 2017, the project was supported by the Ribeirão Preto Blood Bank, the University of São Paulo’s general hospital (HCFM-USP), and Adolfo Lutz Institute. These institutions supplied samples and test equipment.

“The problem is that the available equipment wasn’t ready to be used on a large scale. In addition, viruses could be identified but not classified by the available chemical reaction techniques,” Dentillo says. “We needed more powerful equipment, more effective reagents, and partners for their development.”

The solution appeared at BIO Latin America 2016, a trade show for bioindustry manufacturers, entrepreneurs and researchers held in São Paulo. “We met Custom Biologics there and realized the technologies were complementary. When FAPESP and NRC issued their call for proposals, we formalized the partnership,” Dentillo recalls.

Custom Biologics has more than a decade of experience in developing, validating and implementing bioanalytical and immunological assays and in characterizing and assessing clinical tests for molecules and biomarkers, among others.

The two firms have signed an intellectual property agreement covering the performance of tests to identify HVC. “The project is scheduled to end in 2020, but both of us want to extend the partnership to other projects,” Dentillo says.

“We already have several projects lined up,” Mamelak notes. “We’ve developed prototype tests using the same technology for the rapid identification of Zika, chikungunya and dengue in human biological samples. Our partnerships with DGLab and IAL will pave the way to the development and validation of many other faster and more cost-effective NATs that could help reduce mortality from many diseases and cost burdens for health systems in many countries.”

Company: DGLab
Address: Supera Parque de Inovação e Tecnologia de Ribeirão Preto – Av. Dra. Nadir Aguiar, 1805, Jd. Dr. Paulo Gomes Romeo, 14056-680 Ribeirão Preto (SP), Brazil
Site: superaparque.com.br
Tel: +55 (16) 3315-9940 / 0735

Company: Custom Biologics
Site: custombiologics.com
Contact: custombiologics.com/contact-us