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UK Firm Upfront Diagnostics Plans to Launch Lateral Flow Test for Triaging Stroke Patients Next Year


NEW YORK – Upfront Diagnostics, a Cambridge, UK-based firm, is engaged in a clinical study of a lateral flow test that will allow paramedics to test patients suspected of having had a stroke for large vessel occlusions, enabling them to rapidly triage patients and get them the best possible care.

Called LVOne, the diagnostic relies on two markers and has a turnaround time of about 15 minutes, using blood drawn from a finger prick. Paramedics can read out results visually. 

The company was recently awarded funding to support its test through the UK's Innovative Devices Access Pathway (IDAP), a pilot program that aims to supply the country's National Health Service with new technologies. Eight companies received £10 million ($12.7 million) in funding through the program, and Upfront expects to receive about £1.3 million through IDAP.

According to CEO Gonzalo Ladreda, IDAP will provide his company with an "enhanced regulatory and access pathway" for its LVOne test. As a pilot, the company will also provide feedback that will inform future iterations of the pathway.

Ladreda cofounded Upfront Diagnostics in 2017 originally as Pockit Diagnostics before changing its name last year. Upfront is based at the Cancer Research UK Unit on the Cambridge Biomedical Campus. Based next to Cambridge University Hospital and the headquarters of AstraZeneca and Abcam, Upfront operates with five full-time employees at the moment, Ladreda said.

The company focused on clinical needs first, then sought out the best technology to fill the perceived gap, in this case in rapid stroke diagnostics. "The market fit was found before we developed the technology," Ladreda acknowledged. Further exploration, including a round of discussions with clinical collaborators at Newcastle University in 2017, led the company to conclude that they were moving in the right direction.

"We understood that thrombectomy access was going to become a huge unmet need," said Ladreda. "That gave us an advantage to position ourselves as a leader in this market."

According to Ladreda, when stroke is caused by large vessel occlusions (LVOs), it often leads to death, disability, and associated healthcare costs. LVO is present in a quarter of stroke patients but is responsible for most stroke-related deaths and disabilities. However, this can be prevented in the case of a mechanical thrombectomy within six hours of symptoms. A mechanical thrombectomy is an endovascular technique for removing blood clots from the brain.

Administering such a procedure is complicated however by difficulty in stratifying patients. People with stroke-like symptoms might have small vessel ischemia, intracerebral hemorrhage, a transient ischemic attack, or non-stroke conditions, such as a seizure or migraine, for instance. Confirming a patient has LVO requires a special assessment, including brain imaging. This too is complicated, as there is a dearth of thrombectomy specialists and facilities in the UK and US.

"This inevitably creates a dramatic inefficiency in patient triage," said Ladreda, as most patients will first go to a local stroke hospital before being transferred to a regional unit for LVO assessment. Treatment can be delayed by several hours, and outcomes following thrombectomy are correspondingly poorer.

Upfront Diagnostics' LVOne test could change this situation. "A positive result will direct ambulances towards a regional center instead of any nearer stroke unit without thrombectomy, saving about two hours to treatment," said Ladreda. "This timesaving will also help the healthcare systems to significantly reduce their costs in a moment of historic financial strain."

As a lateral flow test, the technology underlying the test is widely used and familiar to users. The company's main innovation is its blood biomarkers, which Ladreda said are protected by its IP. Upfront tested several markers and found that a combination of glial fibrillary acidic protein (GFAP) and D-dimer were "the best possible biomarkers for the detection of LVO strokes."

In 2021, the company published data in MDPI, demonstrating the LVOne test to be 95 percent accurate with sensitivity of 91 percent and specificity of 98 percent. Investigators at Brigham and Women’s Hospital in Boston, the University of Mississippi Medical Center, and the University of Alabama at Birmingham contributed to that study. Ladreda said a follow-up study replicated the results and that a manuscript describing it is now under review.

According to Ladreda, Upfront developed its test with support from Newcastle University, as well as Innovate UK, the NHS, UK Research & Innovation's Small Business Research Initiative, and the Stroke Association. The company also received a private investment from Cambridge Enterprise and Apex Ventures. This month it also commenced a new financing and is looking for investors to help it cover costs associated with regulatory submissions.

Indeed, Upfront already has its regulatory plans in place. With the data generated in a UK study, the company will pursue both a UKCA and a CE-IVDR mark, which will allow it to sell the test for clinical use in the UK and Europe. Potential clearance for the UK is expected by the first quarter of 2025, while a CE-IVDR certificate could be in hand by Q1 2026. Upfront will also be working with American partners to study its test, with that data used to seek US Food and Drug Administration clearance by the third quarter of 2026, as currently planned, according to Ladreda.

He noted that the company has already transferred its test platform to manufacturing, and that the firm can produce LVOne tests at scale.

Christopher Price is a professor of stroke medicine at Newcastle University in the UK who specializes in emergency stroke care. His research group has been working with Upfront for five years, providing advice around clinical utility and methodology. He is also the chief investigator of the Rapid Assay Diagnostic for Acute Stroke Recognition (RADAR) study, currently underway in five hospitals in England, the aim of which is to show the value of the LVOne test in a suspected stroke population.

Price's research group is providing "scientific independence in evaluating the test" and helped Upfront win the award for the RADAR study. It will also help Upfront with related regulatory issues in the UK, Price said.

According to Price, Upfront's "technology could make a step change in the speed that stroke patients receive thrombectomy treatment, by enabling recognition of this type of stroke while still in the ambulance and allowing direct admission to a thrombectomy-capable stroke center."

He noted that there are bottlenecks in care for stroke patients in the NHS. In England, there are about 96 acute stroke centers, of which 24 offer thrombectomy. "This means approximately 70 percent of stroke patients needing thrombectomy would require a time-wasting transfer between centers, which could be avoided if LVOne allows them to be identified pre-hospital and taken directly to a thrombectomy center," said Price.

According to Price, there is nothing available on the market that would compete head-to-head with LVOne due to "the higher accuracy of Upfront biomarkers."

Nonetheless, other firms are active in the stroke testing realm. One company targeting a similar use case is Geneva, Switzerland-based ABCDx, which has been at work on a test called LVOCheck for a number of years. The company is currently engaged in a study of LVOCheck with Spanish clinical partners and this month announced that it had finished enrolling 380 patients for it. Final results from that study, called BIOSHIP-training, are expected by the end of April, the firm said.

ABCDx CEO Jean-Charles Sanchez said in an email that the firm's LVOCheck test is a triplex lateral flow assay that can be read using a smartphone. He said that ABCDx expects to achieve clearance for the test in Europe and the US sometime next year. He declined to say what markers were included in LVOCheck.

Another company seeking to address the same market is Trianect of Utrecht, Netherlands. Trianect's technology relies on electroencephalogram measurements of a patient's brain, matched with its internally developed algorithms, to triage stroke patients in a similar manner.

According to Newcastle's Price, the RADAR study will continue through September. Results will be submitted for publication, and researchers aim to present their findings at the European Stroke Organization Conference, which will be held in May 2025.