Blood clotting technology a game changer for pathology testing

A medical technology start-up company is aiming to use its innovative blood clotting technology to develop a blood collection tube that will accelerate the diagnosis and monitoring of medical conditions ranging from heart attacks to diabetes.

Q-Sera Pty Ltd, a University of Queensland (UQ) start-up company, is developing technology for producing high quality serum in a clinical setting, based on the blood clotting properties of a protein isolated from a specific snake venom.

Serum is the fluid component of blood plasma that does not contain blood cells or clotting factors. It is isolated from a blood sample using a collection tube containing a clot activator, then spun in a centrifuge, causing the blood components to separate.

Serum is used for many routine diagnostic pathology tests, however the blood of patients prescribed blood thinning medications does not clot easily, making it difficult to produce quality serum for accurate pathology testing.

It has long been recognised that there is a need for a tube that rapidly produces high quality serum from all patients, regardless of the medications they have been prescribed. Serum tubes with a pro-coagulant can accelerate the clotting of the sample, however they are not universally effective and are cost prohibitive for widespread adoption.

Inspired by the potent ability of snake venom to coagulate blood, the Q-Sera technology aims to reduce the time required to produce high quality serum in blood clotting collection tubes.

Based on the research of Emeritus Professor Martin Lavin from UQ’s Centre for Clinical Research, Emeritus Professor John de Jersey from UQ’s School of Chemistry and Molecular Biosciences, Dr Goce Dimeski, Chief Scientist in chemical pathology at Princess Alexandra Hospital and the late Dr Paul Masci from UQ’s Faculty of Medicine, the Q-Sera technology has demonstrated successful clotting of blood samples in less than five minutes, compared with the standard clotting time of 30 minutes using existing silica-based tubes, providing a higher degree of confidence around patient diagnosis and patient care.

Global impact

In 2012, Q-Sera was successful in raising $900,000 from Australia’s Medical Research Commercialisation Fund (MRCF) and university commercialisation fund Uniseed to further develop its technology, recognising its global potential in a blood collection market that was valued at USD 8.50 billion in 2018.

Through to 2026, the demand for blood collection products is expected to grow annually by more than 6% due to increasing rates of infectious diseases, accident and trauma cases, and non-communicable diseases such as asthma. Blood collection products are also used in treating patients suffering from chronic diseases, especially during chemotherapy, dialysis and transplantation procedures.

The research

By isolating proteins in the venom of some of the world’s deadliest snakes, including the Australian Taipan, Q-Sera has developed a novel class of coagulation agents patented for use in blood collection tubes. These agents, or prothrombin activators, were initially sourced from snake venom but can now be produced synthetically from modified cell lines using standard biotechnology manufacturing processes.

Blood collection tubes coated with Q-Sera’s RAPClotTM formulation rapidly produce high quality serum, even in the 10 percent of cases where the blood sample contains anti-coagulants. These benefits may translate into cost efficiencies and reductions for healthcare systems and give improved outcomes for patients.

The path to commercialisation

UQ’s commercialisation company UniQuest saw the potential of this novel technology, supporting its early development through two internal grants – the first in 2008 and the second in 2011. In 2012, UniQuest licensed the technology to start-up company, Q-Sera Pty Ltd.

Since receiving its initial investment from the MRCF and Uniseed in 2012, Q-Sera has raised a further $3.8 million to further develop its technology. This includes independent validation of Q-Sera’s chromogenic bioactivity assay as well as testing to optimise its RAPClot™ formulation.

In 2017, Q-Sera was granted a patent in China for its blood clotting technology, adding to the list of countries in which patents are held, which include Europe, Japan, Mexico, Russia, Canada, South Africa and Australia.

In 2019, Q-Sera was granted a patent in the key US market, providing intellectual property (IP) protection through to 2030.

IP protection extends also to formulations to stabilise the actives in a manufacturing and storage environment. The RAPClot™ technology can be added to standard plastic collection tubes using spray technology , and has a potential 18-month shelf life at room temperature.

In 2020, the company announced a collaboration with JHL Biotech, Inc. (Taiwan) to produce high yielding recombinant ecarin, an essential component of RAPClot™. Through this strategic step, the company aims to demonstrate that the tubes can be produced at commercial scale.