Kura Biotech Pioneers Enzymological Techniques for COVID-19, Narcotics Detection
Tags: Biotech, Science, Enzyme, Covid 19, Technology

By: Olivia Van Dervort

Kura Biotec is a Chilean biotechnology startup whose high-efficiency enzymes have revolutionized testing for illegal narcotics worldwide. With products used by clients spanning from the U.S. Federal Bureau of Investigation and the World Anti-Doping Agency to the U.S. National Institute on Drug Abuse, Kura Biotec’s ability to utilize local waste products for scientific innovation makes the company a leader in the Chilean health technology space.

Manuel Rozas, the son of a Chilean entrepreneur whose company manufactures aquaculture byproducts from salmon industry waste, returned to southern Chile after graduating from university with the goal of applying the same concept to advanced biotechnology. His first breakthrough came in the form of the red abalone, a type of sea snail whose viscera produce an enzyme with massive potential for drug testing. In 2010, Rozas developed the first version of BG100, an enzyme extracted and developed from naturally occurring abalone beta-glucuronidase enzymes. Three years later, he founded Kura Biotec, opened an office in Los Angeles, California, and entered into distribution agreements with major buyers.

BG100 represents a leap forward for high-efficiency enzyme testing, reducing the time it takes to conduct opioid analysis from as many as 16 hours to less than one. The enzyme has since become an essential tool for the purposes of drug testing in forensic, athletic, and judicial arenas; in 2016, it was used in over three million drug tests worldwide.[1] By 2018, Kura Biotec reported annual production of roughly 20 million samples valued at $1 million.[2] The company, still based in the Chilean city of Puerto Varas, now operates in the United States, Europe, Australia, and Asia with a variety of enzyme products for sale, including two others that have broken records for efficiency.

Kura Biotec’s enzymes detect the presence of a vast array of drugs in human and animal urine and blood by breaking down the molecular aggregates formed when drugs are metabolized in the body. By “cutting” these aggregates, the enzymes can trace and measure the presence of specific molecules. After initially extracting beta-glucuronidase from red abalone, Rozas and his team at Kura employed a computational model to apply genetic modifications to the original enzyme, developing an even more efficient version. Kura’s catalog of enzymes can be applied for myriad purposes, and CEO Eduardo Wallach believes this diversity of use is what sets the company apart from competitors: “We offer more than a hundred different applications for the use of the enzymes and, according to the needs of clients, we devise new uses.”[3]

The dynamic nature of Kura’s business strategy is evident through the objectives the firm set for itself in the past year. In 2019, Kura began to pivot toward innovation in genetics with the goal of optimizing DNA tests for early disease detection. The company translated the same mechanisms used for toxicology enzyme extraction and development to genetic enzymology, and though some critical components of the process were not patentable, early investments in research and development (R&D) meant that Kura already had the proprietary knowledge of enzyme extraction to enable the sector shift.

From there, the possibilities for growth were nearly limitless: Kura began to explore proteomics, or the detection of proteins in substances, for purposes like understanding and combatting food allergies. And when the novel coronavirus pandemic reached South America in late February of 2020, catching nearly every industry off guard, Kura’s existing knowledge base served as an invaluable tool and knowledge platform. The company developed a rapid COVID-19 detection test that uses RNA obtained through saliva samples to provide results in only three hours. Kura developed the test in three months, thanks to prior research and a partnership with the Chilean Ministry of Sciences, and is currently implementing its first stage of production with an anticipated capacity of one million tests per month.[4] Wallach, speaking for Kura in an August 18 interview with ITIF staff, stated that the objective of this endeavor is to empower Chilean businesses to recover productivity while actively fighting the pandemic.[5]

A core feature of Kura Biotec’s ethos is a desire to revitalize the community from which it extracts its resources. According to Wallach, the company aims to make Puerto Varas a hub for South American biotechnological innovation. The construction of new state-of-the-art laboratories there in 2018, as well as the addition of 19 new team members from across Chile between 2018 and 2019, suggests significant value addition for the city.

Nonetheless, a sometimes less-than-hospitable innovation policy backdrop in Chile has meant that Kura’s international growth has accelerated at a much faster rate than its domestic growth. The firm gained its first Chilean client, a company that detects hormones in animal meat, less than a year ago. Rozas admits that, despite the fact that all of the company’s R&D takes place in Chile, Kura has not attempted to obtain any patents for its processes or products in the country. The firm has not yet run into any intellectual property disputes, but industry-wide sentiment suggests that Chilean patents are not respected the way that they are in the United States or elsewhere.

Though the nation shows great promise for biopharmaceutical innovation, with efficient allocation of R&D funding and successful programs for attracting entrepreneurs, investors, and global research partners, Chile is held back by weaknesses in its protection of patents and the clinical test data biotech companies like Kura have to submit to regulators before their products can be approved (also known as regulatory data protection). According to the Pugatch Consilium’s 2017 Biopharmaceutical Competitiveness & Investment Survey, “…slow implementation of regulatory data protection and the recent threat of compulsory licensing based on pricing considerations [hinder] an otherwise promising national effort to turn Chile into a hub of innovation.”[6] Chile’s recent dalliances with possibly issuing compulsory licenses on certain biopharmaceutical products in response to the COVID-19 crisis have also raised concerns about the nation’s respect for novel intellectual property rights.

Nevertheless, thus far, the speed of Kura’s innovation process is such that it has managed to stay ahead of competitors without intellectual property protections. However, as the company seeks to build a greater domestic client base and to expand into new industries like genetics and proteomics, it will need greater assurance than mere speed to stay protected.

Intellectual property considerations are vital for the continued success of Kura and for the broader growth of the Chilean biotechnological industry at large. As Rozas points out, a lack of certainty of existing legal protections for Kura’s extraction processes and products has forced the firm to be less open in research and entrepreneurial collaborations. This sense of competition over legally protected collaboration translates to uneasy relationships between actors in the Chilean life-sciences innovation space; Kura has found since its inception that, while basic academic knowledge is available in Chile, there are almost no domestic resources for obtaining applied or industrial knowledge. This dearth of information forces Kura to rely upon other markets for growth and redirects business that would otherwise invigorate the Chilean economy.

Kura Biotech stands out as a pioneer for South American life-sciences innovation; its breakthroughs in enzymology and its ability to rapidly adjust to changing technological needs in the health care space attest to the firm’s unparalleled research capabilities and work ethic. That said, without the proper intellectual property protections, Kura will not stay ahead for long. With an overarching goal to give back to the country from which it extracts its most valuable resources, Kura needs a stronger set of domestic IP protections for its work if it aims to continue to conduct research and business in Chile.

[1] Eva Sanchis, “El molusco “afrodisíaco” que actúa como arma contra el crimen del FBI,” BBC, October 28, 2016, https://www.bbc.com/mundo/noticias-37802255.

[2] Isabe Ovalle, “La enzima chilena del FBI,” Capita, September 20, 2019, https://www.capital.cl/la-enzima-chilena-del-fbi/.

[3] Ibid.

[4] “Laboratorio chileno Kura Biotech logra desarrollar kits de detección del coronavirus,” Grupo de Diarios América, August 20, 2018, http://gda.com/detalle-de-la-noticia/?article=4159426&utm_content=136746611&utm_medium=social&utm_source=linkedin&hss_channel=lcp-3709143.

[5] Ibid.

[6] Pugatch Consilium, “Ascending to the Peak of Biopharmaceutical Innovation: Biopharmaceutical Competitiveness & Investment (BCI) Survey, 4th Edition” (Pugatch Consilium, October 2017), https://www.pugatch-consilium.com/reports/BCI_2017_Report.pdf.