NEW YORK – With technologies gained in a pair of acquisitions this year, UK-based diagnostic firm EDX Medical aims to deliver multiplex lateral flow assays that could help guide disease treatment or differentiate disease types.
The company, which provides PCR-based and other genetic testing from its laboratory in Cambridge, UK, hopes to complete in the coming year a series of assays that employ up to 10 disease markers each, starting with a test for biomarkers associated with elevated risk of developing sepsis and followed by tests for infectious diseases, cancer-causing viral infections, neurological diseases, and cardiovascular diseases.
For its lateral flow assay business, EDX Medical CEO Mike Hudson said the company intends to "take the performance that you know is possible from the laboratory world and translate that into a point-of-care test or device that can give you similar levels of performance and reliability."
Hudson said the company's point-of-care tests will combine the precision in vitro diagnostics and immunochemistry expertise EDX gained when it acquired its Torax Biosciences subsidiary with the miniaturization and lateral flow assay design capabilities it gained with its acquisition last month of Hutano Diagnostics. The tests will also incorporate EDX's technology for reading and interpreting colorimetric assay results through smartphone cameras and software.
Arrays of miniaturized testing dots within each assay provide multiplexing capabilities, and the company aims to deliver results from each test in about 15 minutes. How each test works depends on the application.
"You can think of each little dot being a lateral flow test in its own right or a chemical fluorescence test," he said. "And the beauty of the Hutano technology is that each test and each chemistry in each little dot can be different."
While those tests are under development, the firm also bolstered its business this month with a deal to distribute two of Guardant Health's cancer liquid biopsy tests in the UK, Denmark, Finland, Iceland, Norway, and Sweden.
In announcing the Hutano acquisition, company officials said its pipeline of assays will improve on existing lateral flow testing technology by replacing them with an array of highly sensitive "mini-tests," each of which replaces a traditional lateral flow or laboratory test. The tests are designed for use by healthcare providers at the point of care and will be used to identify early signs of cancer, infections, and cardiovascular conditions.
In a multiplex test, the dots can be used to detect, characterize, and differentiate among potential infection sources, Hudson said. In a single-disease test, the dot arrays can help guide treatment by providing quantitative results or by targeting biomarkers for different stages of disease progression.
Lateral flow testing is an already mature technology, but because of the COVID-19 pandemic, demand for such tests soared, putting the spotlight on the development of the technology. In response, diagnostic firms and academic labs have worked to apply new technologies to the format or augment its abilities through other technologies, whether for infectious disease testing or a broader landscape of health indications including the early detection of Alzheimer's disease and detection of lung cancer or bladder cancer.
EDX's sepsis test emerged from a five-country collaborative study led by Médecins Sans Frontières (MSF), also known as Doctors Without Borders, and the University of Oxford into methods of identifying the risk that children presenting with acute febrile illness will develop serious illness, including sepsis. As part of that project, Hudson's research team was asked to help identify the biomarkers that would be used in field testing to identify the rising risk of sepsis and disease progression.
EDX is now trying to define how many of those biomarkers are needed to make treatment decisions.
"Do we need five or eight, or is three even enough for you to deal with what is the frontline diagnostic decision on treatment?" Hudson said. "I think we'll be in that middle ground in terms of the product that we plan, so five or six, probably."
He declined to define those biomarkers more closely except to say that they reflect various pathways that break down during sepsis. Further information will be published in study results from the leaders of the febrile illness study, he said.
EDX is preparing its tests to meet European regulatory standards under IVDR, and Hudson said the firm is working with clinical partners in Asia to develop its first test for biomarkers associated with sepsis risk. He expects that test will be fully developed within a year.
"We've already now established a number of other products that will come in from oncology, cardiovascular disease, and viral infections, which are areas that we can access from a development point of view very rapidly because of our laboratory experience of already running assays in those areas," he said. "And the translation into the Hutano platform is something we will be doing during this coming 12-month period."
The company plans to eventually make its tests available in the United States, although Hudson said the firm is still determining the appropriate regulatory pathway to get marketing approval from the US Food and Drug Administration.
"We will most likely form partnerships with specialist distributors in the clinical areas in which we operate," he said. "I'd expect several EDX products to be in the USA by early 2025."
Beyond sepsis testing, the firm also sees potential to apply its lateral flow technology to cancer testing. Hudson said the company will not be developing new biomarkers but instead will apply known ones into multiplex prognostic assays that can help identify a cancer type, its location, and how aggressive that cancer is likely to be.
In infectious disease testing, Hudson said EDX is also interested in developing assays that could differentiate HPV strains that are known to be nonmalignant from those linked with cervical and oropharyngeal cancers. The firm is particularly interested in testing for viral-induced cancers, including hepatitis C-linked cancer.
"HPV and cancer are both very doable for us given our existing insights into the field," he said. "And then, behind that, few are looking in neurology around dementias, Alzheimer's disease, Parkinson's, so neurodegenerative disorders is an area where this technique, these methods, are really applicable now. Multiplex tests are giving you the power to get early prediction of risk."
Hudson estimates EDX's smartphone-readable tests will cost between $25 and $150, depending on the number of targets and the overall complexity of each test. At that price, he anticipates payors will be willing to cover the costs of each device. He hopes the company's technology will also help reduce delays in receiving care by providing results that are complementary to laboratory tests such as sequencing panels.
"These types of technologies will be instant, they'll be done at the bedside or in the home, even, by doctors, and that will make a massive difference," he said.