Skip to main content
Premium Trial:

Request an Annual Quote

UK Diagnostics Firm 52North Plans 2025 European, US Launches for Neutropenic Sepsis Test


NEW YORK – UK diagnostics firm 52North Health is preparing to launch on the British, American, and European markets next year a test for neutropenic sepsis, a condition that often occurs in cancer patients receiving chemotherapy that can be fatal if not treated immediately.

The test, called Neutrocheck, relies on a lateral flow assay that can be run on a small, in-house devised device that can fit in the palm of a user. Using Neutrocheck, a cancer patient undergoing chemotherapy can with a simple blood prick determine if they are at heightened risk for neutropenic sepsis, enabling them to know if they should head straight to the hospital for monitoring and potential treatment or if they are not at heightened risk and can potentially be managed at home.

Saif Ahmad, chief scientific and medical officer at the Cambridge-based company, cofounded 52North six years ago in part to address the need for a test that could triage cancer patients undergoing therapy. In addition to his work at 52North, Ahmad also has a research position at the University of Cambridge, as well as a clinical position within Addenbrooke's Hospital, where he routinely treats patients suffering from neutropenic sepsis.

The standard routine for patients at risk of developing the condition is to seek care immediately, but he noted, some don't actually need care, while others need treatment immediately.

"When someone is having chemotherapy, there are enough things going on, but having the specter of sepsis in the background, and not being able to identify the right people was always something that I have seen as a bit of an unmet need clinically," Ahmad remarked.

The idea for a test that could help triage such patients, both saving lives and reducing unnecessary hospital visits, led Ahmad to cofound 52North in 2018 with other postgraduates at the University of Cambridge, including Umaima Ahmad, now the company's CEO. She previously held business development and legal positions at AstraZeneca and Abcam. 

The other cofounders are Nikki Weckman, now an assistant professor at the University of Toronto with a background in engineering and nanotechnology who serves as the chief technology officer, and Mireia Crispin, an assistant professor at the University of Cambridge and the chief digital officer at 52North.

An initial pitch to a postdoc business plan competition won the startup an initial £10,000 award (about $12,800), which led to 52North's first experiments and data generation. They also began to look into potential technology platforms to support their test. Ahmad said that 52North reviewed various microfluidic solutions, but deemed them to be too expensive for the kind of at-home, self-monitoring test they intended to offer the clinical market.

"We didn't really think that would be able to be adopted at a scale where we could have a maximum impact," he said of such platforms. The company then decided to build its own lateral flow assay, identifying the markers they would ultimately select for Neutrocheck. They worked collaboratively with a contract research organization to craft a home-use device that can move blood obtained from a finger prick across different strips on the test.

52North also managed to pick up additional funding along the way, Ahmad said, including a £125,000 Medtech Accelerator grant, as well as a separate £100,000 grant through Innovate UK, the funding arm of UK Research and Innovation, a government-funded body, both in 2020. Last year, Macmillan Cancer Support, a large British charity, invested £100,000 in the firm.

"That allowed us to increase the scale of our experiments and push things forward," said Ahmad of the earlier investments. When the COVID-19 pandemic hit at the start of 2020, 52North had to grapple with working remotely, and management didn't meet some new hires in person for months. But the pandemic also had positive benefits for UK diagnostics firms.

"Interestingly, we don't have to explain lateral flow in the same way as before," said Ahmad. "There was skepticism around COVID-19 tests, regarding their accuracy, but the more people started using them, they realized their value as part of a screening or triage system," he said.

Patients also got used to the idea of testing themselves at home. UK authorities supported the scaling up of manufacturing facilities, which means that today, with the peak of the pandemic long in the rearview mirror, there exists within the UK "quite a lot of capacity" for manufacturing lateral-flow tests, Ahmad said.

While manufacturing capacity has increased, hospital capacity is increasingly constrained, both in the UK and US, Ahmad added. Health systems therefore want to prevent unnecessary admissions, a need that 52North aims to address by offering a test that can help triage sepsis patients quickly, reducing healthcare costs, as well as saving their lives.

The use of lateral flow tests during the pandemic also inspired 52North to streamline its design. The test can be read visually, and a smartphone can be used to read the test results. The test itself includes markers related to symptoms of neutropenic sepsis and neutrophil levels, as well as a control.

"It's built on quite an exciting system that can interpret the result for you," said Ahmad.

The small device fits in one hand and includes a dial containing buffer capsules that are released into the device once turned, unlike a COVID-19 test, where people add the buffers themselves.

The cost of the test is to be determined. Ahmad said 52North's device can be manufactured at low cost, with cost of goods, when made at scale, anticipated to be less than $10.

Now, 52North, which has grown to a team of a dozen people, is preparing to submit Neutrocheck to UK, European, and US regulators within the next 12 months, so that the test can be used clinically. 52North will thus be seeking to gain UKCA and CE-IVDR marks, as well as US Food and Drug Administration clearance for Neutrocheck by early 2025.

To support these goals in part, the company recently received funding through the UK's Innovative Devices Access Pathway (IDAP), a new pilot program that aims to supply the country's National Health Service with new technologies. Eight firms received £10 million ($12.7 million) in funding through the program.

"The assistance and support is in some ways more valuable than any funding," Ahmad remarked, and the test may be fast-tracked by regulators such as the UK Medicines and Healthcare Products Regulatory Agency. Meanwhile, the firm will have access to senior people within the NHS, including meetings with stakeholders who will help the company get the test on the market.

And as 52North does so, it is also thinking of its next moves. An "obvious extension" is to test neutrophil levels, which are relevant not only for cancer patients undergoing chemotherapy, but also anyone at risk of a blood infection. Another potential business opportunity is to make its newly designed lateral flow device available to other diagnostic and pharmaceutical companies to support their own tests.

"In part by design and in part by coincidence, we invented a novel scientific solution: one that could be applied more broadly," said Ahmad. "The ability to detect cells in a low-cost way can be applied in many other scenarios."