NEW YORK – Swiss molecular diagnostics company ABCDx and South Korea's Precision Biosensor are working together to develop and commercialize a rapid test for acute brain stroke that they believe could be used in emergency departments to better manage patients and make treatment decisions.
The companies were recently awarded a €2.4 million ($2.8 million) Eurostars grant to support the development and validation of the assay. Eurostars is a European funding program open to small and medium-sized enterprises. According to ABCDx CEO Jean-Charles Sanchez, this particular Eurostars call was for projects that included both European and Korean partners.
In the consortium, Precision Biosensor will integrate ABCDx's biomarkers for acute brain stroke into its time-resolved fluorescence immunodiagnostic platform. The Daejeon-based firm's Exdia TRF instrument employs technology developed for satellite cameras to image biomarkers in cartridges. The approach combines two-dimensional microlight detection with an optical timing control technique to produce results that the company claims are competitive with other methods used in lateral flow assays, such as absorbance or fluorescence.
Precision Biosensor already has cartridges on the global market for a variety of indications, including a cardiac panel for myocardial infarction, heart failure, and cardiovascular disease; and an infectious disease panel for SARS-CoV-2, influenza, and other infections. Backed with the new funding, it will now create a cartridge that uses ABCDx's markers and trial it in partnership with Seoul St. Mary’s Hospital. The current project is expected to last for the next two years.
Headquartered in Geneva, ABCDx has since 2014 worked to translate discoveries from the University of Geneva, where Sanchez is a proteomics researcher, as well as Vall d’Hebron Research Institute in Barcelona, into lateral flow assays that can be used to better manage and treat patients presenting with acute brain stroke or traumatic brain injury. It has developed and launched its own tests in the past.
One of its tests is StrokeCheck, which measures the levels of brain marker proteins, including N-terminal proB-type natriuretic peptide, or NT-proBNP, in a patient's blood, and then after assessing other data, such as blood pressure and neurological symptoms, determines whether the patient has suffered an ischemic or hemorrhagic stroke.
This is important information to have when treating a patient, as ischemic strokes, which comprise about 80 percent of cases, are caused by blood clots and thus can be remedied with a thrombolytic agent to dissolve the clots. Hemorrhagic strokes, which make up the remaining fifth of stroke cases, are caused by ruptured blood vessels which should not be treated by thrombolytic agents and, in fact, such accidental treatment can cause more damage to patients.
Typically, stroke patients are taken to hospitals where they are assessed via CT-scan prior to receiving treatment. But if ABCDx's StrokeCheck test were employed early, patients could start receiving therapies that could potentially reduce the effects of their stroke.
"When you have to treat an acute stroke patient," noted Sanchez, "you have to be fast in diagnosing the patients, and you are in need of a triage to know how to treat the patient."
The company and its partners described the use of StrokeCheck in 189 stroke patients in the journal Neurology earlier this year.
Sanchez said that the test resulting from the partnership with Precision Biosensor will "be very similar to StrokeCheck," noting that StrokeCheck can be transferred to any platform. "We can license it to them, and we can license our IP to different companies with different platforms," he said.
Precision Biosensor is a company in the midst of not only expanding its menu but expanding its market presence. Founded as Terawave in Daejeon, a city of 1.5 million in South Korea, the company merged with a firm called Nano-Ditech in 2015 and renamed itself Precision Biosensor, making Cranbury, New Jersey-based Nano-Ditech a wholly owned subsidiary and giving Precision Biosensor a presence in North America. The company also maintains an office in Seoul and had an IPO on the KOSDAQ last year, in which it raised KRW 18.75 billion (about $16 million). The company currently employs 93 people worldwide.
Hanshin Kim, CEO at Precision Biosensor, said that the company decided to partner with ABCDx given its "wide portfolio of patients and clinical validation experience" as well as its ability to differentiate between ischemic and hemorrhagic stroke. This meshed with its own interest in offering a variety of in vitro diagnostics based on its TRF technology, he said.
"By collaborating with each other, both companies can benefit from the project and can successfully develop a point-of-care test product," said Kim.
Kim confirmed the Eurostars funding will allow the firm to develop a lateral flow assay cartridge for triaging stroke victims that will be deployed in ambulances on its TRF platform. "By developing such a stroke test cartridge, our ultimate goal is to replace the existing, expensive CT scan and MRI diagnostic market," said Kim, "making CT scans and MRI [more useful] for follow-up consultations where more details are required."
Kim noted that market demand exists for such a test today, as stroke is a "leading cause of long-term disability and the second highest registered cause of death worldwide." Indeed, according to the World Health Organization, stroke was the second leading cause of deaths in 2019, accounting for 11 percent of all deaths globally.
According to Kim, Precision Biosensor is discussing with ABCDx what its approach to market will be, but that it aims to "find the best way to be a game changer" by relying on both ABCDx's existing users as well as Precision Biosensor's customers and distribution channels to make the test widely available.
The companies' regulatory strategies depend on the region. Europe is currently transitioning to a new regulatory regime under its In Vitro Diagnostic Regulation, set to come into effect in May 2022. However, there has been some uncertainty regarding the capacity of notified bodies to handle the amount of new IVD submissions by that date. Nevertheless, ABCDx intends to submit its test for clearance in Europe under the IVDR, confirmed Alberto Schena, the company's chief technology officer.
Schena added that while the US Food and Drug Administration's hands are tied up with addressing the ongoing COVID-19 pandemic at the moment, ABCDx believes it will resume its activities, and that within two years ABCDx does not foresee problems in gaining FDA approval. Schena noted that Precision Biosensor has experience with the Korean Ministry of Food and Drug Safety and will seek approval for the test on its platform there following the conclusion of the new validation study.
Precision Biosensor's Kim estimated that it could take about two years to develop the test and complete a clinical study before seeking such clearance. He noted that the company will plan its clinical study to meet the needs of the MFDS, the US FDA, and European regulators.
Concerning the cost of the test, Schena said it was too early to comment. "Most likely it will actually be integrated into a software-as-a-service platform, in which the hospital pays for a subscription," he said. Schena added that the company has undertaken a cost utility study of its test and predicted the use of StrokeCheck could save around €700 per patient. "Given the much higher healthcare costs in the US, we expect much higher savings in the US," Schena said.
Kim agreed. "In terms of cost and price, as we have not begun development yet, it's very hard to estimate, but we believe it will ease the financial burden on patients and national healthcare systems compared to typical diagnostics, such as MRIs," he said.
ABCDx has other tests in its menu. One, called TBICheck, is intended for assessing mild traumatic brain injury and relies on the measurement of the protein H-FABP in patient blood. The aim is again to triage patients, so that unnecessary CT scans of patients can be avoided. ABCDx achieved a CE-IVD mark for the lateral flow assay in 2019. It has a turnaround time of about 10 minutes.
Schena noted that ABCDx also has a test called LVOCheck in development. This test will be used in ambulances to triage large vessel occlusion patients and to send them to the closest reference stroke center for thrombectomy. He said ABCDx expects the test to be available in 2023.