The BioCODE Nanosensor, to determine disease risk in patients (detecting inflammatory biomarker levels from a drop of blood) and developed by experts at Stellenbosch University in South Africa, received a funding boost from the newly established University Technology Fund (UTF)
While you read this article, there will be at least 4 500 cancer fatalities and 8 000 from cardiovascular disease, according to the World Health Organisation. These statistics are exacerbated by the circumstances and lack of health care for many of these victims in developing countries.
Prof Resia Pretorius, Head of Stellenbosch University's (SU) Physiological Sciences Department in the Faculty of Science, and her team of researchers, engineers and scientists, hope to address these needs with the patenting and development of the BioCODE 2-in-1 nanosensor to determine disease risk in patients.
Pretorius says cancer and cardiovascular diseases are often characterised by type 2 diabetes, stroke, heart attack and thrombosis, and the golden thread that links all of these conditions is systemic inflammation. "This inflammation is the result of increased circulating inflammatory biomarkers, including serum amyloid A, P-selectin and abnormal blood protein folding. These biomarkers are the cause of sticky blood and their presence greatly increase the possibility of getting a stroke, a heart attack or deep vein thrombosis."
Introduced by Anita Nel, Chief Director of Innovation and Business Development, who heads up Innovus, SU's technology transfer office for the commercialisation of the Institution's assets, Pretorius, Prof Anna-Mart Engelbrecht a cancer researcher, also from the department of Physiological Sciences, and Prof Willie Perold from SU's Department of Electrical and Electronic Engineering, developed a protocol for a small portable and cost effective nanosensor.
The BioCODE team was the first recipients of funding from the newly established University Technology Fund (UTF).
Innovus was instrumental in working with the researchers to secure funding for the first stages of the development work of the BioCODE, the patenting thereof and the establishment of a company that is currently being incubated at SU's LaunchLab.
The sensor will be relatively cheap to produce and small enough to be used by a medical practitioner in his or her rooms and for nurses in mobile clinics. A second part of the sensor detects spontaneously formed sticky blood clotlets in circulation, using smartphone based technology. Perold says it is very exciting to be part of this multidisciplinary team of experts. "I do believe that many of the solutions of current day problems lie in this approach."
Pretorius said the BioCODE detects inflammatory biomarker levels from a drop of blood. "The serum amyloid A and P-selectin molecules in a person's circulation are upregulated when you have a risk for cancer or cardiovascular disease. To measure these molecules, we use antibodies which we immobilise on a test strip for the BioCODE," said Pretorius who, in 2018, already received funding to produce the antibodies in alpacas. They are now in the process to compare the antibodies to commercial ones.
In practice, a medical practitioner would usually send blood away to pathology laboratories for biomarker analysis. With the 2-in-1 nanosensor, the practitioner no longer has to send the blood samples away. Putting drops of a patient's blood on strips with serum amyloid A and P-selectin, will enable a practitioner to determine levels of the biomarkers in the patient. "Although one cannot determine what kind of cancer a patient might have per se, if serum amyloid A is greatly increased in circulation, it could suggest that a type of cancer is prevalent, and further testing can be done. "For instance, if the serum amyloid A levels are very high in a male patient, one can test for prostate cancer or in the case of a female patient, for breast cancer". These biomarkers are also significantly upregulated in cardiovascular disease. The clinician still would need to make the final diagnoses, based on the usual clinical diagnostic processes.
"Our aim is to constantly improve the sensors to finally being able to detect specific cancers. We are currently also working on a sensor for the early detection of pancreatic cancer; since it is usually detected at a very late stage with a poor prognosis for these patients. This sensor will enable us to detect this cancer at a much earlier stage which will make 'n huge difference to the life expectancy of these patients with a current life expectancy of only 3-6 months," says Engelbrecht.
Pretorius said the nanosensor could even be used to predict increased cytokine activity that is characteristic of the cytokine storm during COVID-19.
The prototype of the electronic part of the nanosensor is currently being finalised. BioCODE's first employee, Este Burger, who recently graduated from SU as an engineer, is working on the development of the smartphone-sensor for the company.
Dr Andre du Toit (post-doc researcher) and Greta de Waal (PhD student), both from the Department of Physiological Sciences, assist the team in the immobilisation of the antibodies onto the test strips.
Also part of the BioCODE team is SU's Rector and Vice-Chancellor, Prof Wim de Villiers, (who is a gastroenterologist, with a special interest in serum amyloid A in colorectal cancer) who, together with Pretorius, Engelbrecht and Perold, holds the patent for the BioCODE and shares the supervision of a PhD-student with Pretorius.
"BioCODE is the right product for the right time in South Africa today," says De Villiers. "Not only is it cost effective to produce, but it will enable medical practitioners to give people in our rural areas access to valuable medical screening which is currently not possible to do. For me it is an honour to be part of a young and dedicated team that is creating a home-grown product that will be used by the medical practitioners around the globe."
Pretorius expresses her thanks to the UTF for funding the research. It will enable the team to successfully reach the milestones which will provide leverage for further funding. "We will need to produce ten of the BioCODE 2-in-1 sensors and pull in an independent company which will draw blood and do tests on the BioCODE to determine if it will give consistent and comparable gold standard results. This will eventually lead to prototrials towards the end of milestone three at the end of 2020, which could put BioCODE on a path towards becoming a commercially viable product."
Stocks & Strauss, who was appointed as fund managers for the UTF fund, believes that BioCODE is an unique investment opportunity, says partner Wayne Stocks. "It is our opinion that the science is novel, the market is an exciting one, and the BioCODE team has the expertise, experience and passion to achieve the milestones identified to prove and commercialise the technology on a global scale."