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Fast MDx Introduces Automated PCR Testing System, Partners with Public Health Wales


NEW YORK – Fast MDx is preparing to enter the molecular diagnostics market with an open, fully automated, high-throughput PCR testing platform that it believes can compete against entrenched players like Roche, Becton Dickinson, and Hologic.

The UK firm has found an early partner in Public Health Wales, which will soon begin validating the platform, and this year intends to place 10 preproduction units with lab partners. This will be followed by full production of its Fast MDx platform in 2025, after which the company foresees "hundreds of platforms being placed," according to CEO Richard Lewis.

"We offer an open platform that you can put laboratory-developed tests on," Lewis said, noting that the company is also working with assay manufacturers, so that small- and medium-sized assay manufacturers can sell their tests directly to laboratories that have a Fast MDx system installed.

"This opens up a whole new market" for assay manufacturers, he added, "because they haven't had access to automated solutions." He noted that the automated systems sold by larger molecular diagnostics players like Roche, BD, or Hologic are closed platforms, meaning that they are intended to be used with assay kits provided by the same company.

Fast MDx is based in Perivale, a west London suburb, and employs 27 people in the UK and Germany. The company is privately funded. The firm was originally known as BJS Biotechnologies and spun out of the BJS Group in 2011 to commercialize fast thermal cyclers for PCR testing. BJS Group, a metal electroforming and electroplating company also based in Perivale, was cofounded by Lewis' grandfather, Benjamin, in 1945.

"Our aim is to be pretty disruptive and halve the cost of testing, simplify the testing, and allow people to put their own assays onto the platform," said Richard Lewis.

Lewis has been involved with PCR since the early 1990s. Fast MDx was originally established to serve the market for thermal cyclers. The company launched an ultra-fast qPCR thermal cycler in 2015 and also took part in a consortium focused on sepsis testing at that time. When the COVID-19 pandemic hit though, Fast MDx decided to invest more intensively in molecular diagnostics, with the goal of making available a mobile, open platform for PCR testing. To support its new focus, the firm joined the British In Vitro Diagnostics Association last year, and it achieved ISO:13485 certification In October 2023.

The firm's platform is 1.6 meters high and stands on four lockable casters. It includes the company's latest qPCR thermal cycler and reverse-transcription block technology, as well as its Pathtubes technology, which automates both the sample preparation and handling steps. The automation elements of the Fast MDx are manufactured by Festo, a German firm.

Given its footprint, the company claims on its website that the Fast MDx can be transferred to any location as it is "small enough to fit through any doorway and into any elevator." Users can assay 92 samples per plate, plus four controls, with a turnaround time of about 45 minutes to an hour. Fast MDx envisions its system could be transported to rugged areas in low- or middle-income countries to provide testing near patients and at high volume.

Again, the pandemic shaped the vision of the firm. According to Lewis, turnaround time for PCR-based SARS-CoV-2 testing in the UK during the COVID-19 pandemic typically ranged from 24 to 48 hours from obtaining the sample to returning electronic results. Fast MDx would like to shave that down to about two hours using its automated platform.

But such circumstances are just a potential application area for Fast MDx. Lewis said the platform could be used for mass screening, and looking for biomarkers that show predisposition toward disease.

"Rapid results can reduce the spread of disease and reduce healthcare burden," he said.

Most immediately, the system will be deployed to Public Health Wales, where it will undergo validation alongside the platforms the national public health agency currently uses for molecular testing. According to Public Health Wales' website, the agency uses BioMérieux's Biofire platform for rapid respiratory molecular testing.

Catherine Moore, a consultant clinical scientist at the Wales Specialist Virology Centre in Cardiff, which offers molecular testing services to the Public Health Wales network of laboratories, confirmed in an email that the center would be assessing the Fast MDx platform.

"We have agreed to look at the system," she said, adding that the center has similar partnerships with other companies to assess if their systems might be suitable for use in Public Health Wales' laboratory network.

"I think these types of platforms are the direction of travel for many commercial companies," Moore noted. "There is certainly an appetite for them, and choice is never a bad thing."

For such a user, Lewis said the Fast MDx platform could reduce the need for skilled biomedical scientists to do "laborious, mundane high-throughput testing," freeing them to run more complex tests, while lower-level technicians could manage the Fast MDx instead.

He noted that such labs often use modular equipment to extract and purify nucleic acids, followed by liquid handling of the assay kit with the samples and running them using 96-well microtiter plates on a real-time thermal cycler. All of these steps can create more issues.

"Truthfully, during the pandemic, we saw lots of human handling errors, when people were aspirating hundreds of samples a day," remarked Lewis. "These were really clever people doing monotonous work," he said. "We have simplified it and taken out the drudgery of doing such repetitive work."

There are, however, other companies targeting the same space, at least in part. Hologic, for example, does allow users to design their own assays and run them on its high-throughput Panther Fusion instrument, which enables the testing of 500 samples in an eight-hour shift. Qiagen similarly supports laboratory-developed tests on its NeuMoDx Molecular System, which can run 30 assays in between 40 and 80 minutes.

According to Lewis, Fast MDx is not going to get into assay development, given its size and specialty in automation and engineering, Lewis noted. Instead, the company will work with assay manufacturers that will sell to customers in parallel with Fast MDx, and together they will do joint marketing. Lewis said that Fast MDx is considering a project with National Health Service England to offer a urine-based test for human papillomavirus (HPV) on its platform that would eliminate the need for pap smear tests and allow men who are carriers to be tested for the first time.

The company is interested in partnerships as it navigates its way into the molecular testing market. Lewis said there are "quite a few tier-one manufacturers out there" that don't have such automated platforms. Ideally, Fast MDx would partner with a manufacturer that could then distribute its automated platform.

"I think we are very disruptive," he said of the company's chances, noting that the company will install its platform in partners' labs free of charge, while charging a small fee per test, with a minimal number of daily tests expected.

"We also are insisting that the platform stays open so that users can use their own laboratory-developed tests, as well as buy assays from a test manufacturer directly and at much lower cost." he added.