Prolight’s partner TTP provides update on MicroFlex development
With the goal of delivering diagnostic tests closer to the patient, Prolight Diagnostics and TTP have developed the Point-of-Care system MicroFlex which brings the benefits of central-lab quality ELISA testing to more distributed environments with a compact and more user-friendly package. BioStock spoke with Ben Metcalf, consultant at TTP, to learn more about MicroFlex and why it is referred to as a “central-lab in-a-box”.
– We believe the MicroFlex platform has potentially broad appeal to a range of different companies wishing to enter or improve their offering in the distributed immuno-diagnostic space, says Ben.
While Prolight Diagnostics has been focusing on the development of the Psyros POC system for troponin testing, its development partner TTP has been working on the MicroFlex POC-system. This system is suitable for targeting a range of biomarkers in various areas, including inflammatory and infectious diseases, reproductive health monitoring, gastro-intestinal testing, as well as cardiac and neurological markers.
Since 2022, Prolight and TTP has a commercialisation agreement under which TTP is responsible for ongoing external initiatives and discussions to secure an industrial partner for MicroFlex. Under the commercialisation agreement, Prolight will benefit as future revenues are generated.
Development is not affected by impairment
TTP sees great potential in the MicroFlex system for several biomarkers, but Prolight believes that its Psyros system holds greater potential specifically for troponin testing. Thus, Prolight recently wrote down the capitalized development costs regarding troponin testing on the MicroFlex system with 113 Mkr.
– The write-down is based on that testing with the single biomarker troponin on the MicroFlex POC system is no longer believed to be as suitable as Prolight’s digital POC system Psyros has demonstrated superior performance. The write-down is therefore something we are obliged to do according to established accounting principles, says Prolight Diagnostics’ CEO Ulf Bladin.
– The commercialization agreement signed with TTP in November 2022, is not affected by this decision since it covers several other biomarkers which are believed to have a big market potential. TTP continues to drive the development towards commercialisation.
MicroFlex enables performance of ELISA tests
The MicroFlex system is an easy-to-use immunodiagnostic system for measurement in whole blood samples, with the ambition of bringing central-lab quality ELISA protocols and data to the desktop. This makes it suitable for distributed testing, i.e. moving the testing process from the large centralised labs closer to patients in need.
ELISA (Enzyme-Linked Immunosorbent Assay) is a commonly used laboratory technique for detecting and quantifying substances such as proteins, peptides, antibodies, and hormones. The method relies on the specific binding between an antigen and an antibody, coupled with an enzymatic reaction to produce a measurable signal.
Easy-to-use and fast
The MicroFlex platform combines the ELISA assay technology into a cartridge format with the Flex Membrane technology developed by TTP. The combination of these technologies has the potential to achieve ELISA test performance in a convenient format for distributed diagnostic testing.
MicroFlex technology allows ELISA tests with a small, disposable cartridge. The MicroFlex system also has a built-in centrifuge and the capability to load the blood sample tube directly into the test cartridge, significantly simplifying handling. This approach is a faster and easier alternative to measure substances in blood compared to perform the traditional ELISA process with microtiter plates.
EcoFlex – a novel environmental cartridge
TTP has recently developed a novel, more environmental-friendly cartridge approach called ecoFlex. The ecoFlex cartridge is based on the same underlying MicroFlex technology but uses recycled paper pulp for the majority of the cartridge construction, resulting in 95 per cent reduction in plastic use compared to the MicroFlex cartridge (that is designed for higher volume liquid processing).
The paper-pulp cartridge can be manufactured using less than 2g of plastic but is still able to deliver central-lab quality ELISA results. With a target cost of under USD 1, ecoFlex is competing with lateral-flow strips that are less sensitive and results in massive plastic waste.
MicroFlex showcased at congresses
TTP is looking for partners wishing to engage in the next stages of developing and commercialising the MicroFlex or ecoFlex POC platforms. To achieve this goal, TTP has been showcasing the MicroFlex system to potential partners at various congresses; most recently at European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2024 in Barcelona and soon at ADLM 2024 in Chicago between July 30 and August 1 this year.
One of the representatives from TTP at ESCMID was Ben Metcalf, consultant at TTP. BioStock reached out to Ben Metcalf to gain further insights in the development of MicroFlex.
First of all, what is your background and role at TTP?
– I am a physicist by background, having previously spent time researching and developing ultra-sensitive optical detectors and joined the TTP Life Sciences department around 8 years ago. Since then I have been primarily involved in developing new diagnostic technologies and products ranging from point-of-care molecular diagnostic platforms, through immuno-diagnostic systems to large laboratory single-cell analysis systems. I was heavily involved in the technical development of the MicroFlex platform and am now working to help promote the platform within TTPs existing network of commercial partners and explore new opportunities with other interested partners.
Can you provide an overview of the key features and competitive advantages of the MicroFlex system?
– The Flex Membrane technology at the heart of MicroFlex is the key enabling feature. It allows all of the complex fluidic steps found in a central-lab ELISA workflow – mixing, washing, magnetic-bead trapping and re-suspension and optical read-out – to be replicated using very simple and cheap flexible plastic films heat-welded together. This reduces the complexity and cost of the consumable and device needed to implement the workflow. Because MicroFlex can directly replicate the common workflow steps found in central-lab ELISA workflows, including chemiluminescence detection, the effort required to translate existing assays onto the platform is dramatically reduced. This makes the MicroFlex system an attractive option for those wanting to move existing assays from the lab to distributed environments – the flexibility of the fluidic system allows for a whole variety of different workflows to be programmed in using the same hardware.
– Built around this core ’Assay Engine’ – the MicroFlex system also includes a novel integrated centrifuge for fast, high-performance, on-board blood-to-plasma separation, further reducing the differences between the lab (where all blood samples are typically centrifuged on the bench to generate plasma or serum before being run on the ELISA instruments) and the point of care platform. The addition of a direct vacuum tube loading system eliminates the need for the user to perform any kind of secondary sample transfer, reducing errors, time and effort from the testing process – making MicroFlex an almost direct swap-in for sending blood tubes to the central lab. We are not aware of any other system which is able to combine all of this functionality and flexibility within a compact instrument whilst still requiring only a single consumable.
TTP has also developed a novel cartridge, ecoFlex, with sustainability in focus. Could you tell us a bit more about it?
– The ecoFlex concept arose from the desire to explore how we could use the MicroFlex approach to address a broader market opportunity – bringing central lab quality quantisation and sensitivity to a lateral flow cost point. Whilst the original MicroFlex cartridge included advanced features, such as the on-board centrifuge and vacuum-tube integration, not all tests require such capability and instead would benefit from a simpler, cheaper format. Therefore, we began an internal project to reimagine and highlight the key capabilities of the MicroFlex technology – the ability to perform all of the key steps of a central lab ELISA within a simple, cheap flexible plastic film – whilst also trying to address an increasingly important demand to reduce plastic usage in single-use diagnostic tests.
»The ecoFlex concept arose from the desire to explore how we could use the MicroFlex approach to address a broader market opportunity – bringing central lab quality quantisation and sensitivity to a lateral flow cost point.«
– The core MicroFlex technology allowed us to consider materials other than plastic for the cartridge body due to the way it interacts with the instrument. Consulting with pulp product manufacturers we were able to develop a design that supported the assay strip and could be produced at scale at a similar price to a lateral-flow test strip. ecoFlex can be manufactured using less than 2g of plastic, the novel paper-pulp cartridge is still able to deliver central-lab quality ELISA workflow by leveraging the existing MicroFlex technology. With a target cost of <$1, ecoFlex cartridges would be competitive with existing lateral-flow strips whilst delivering the quantitative performance of a central lab in a portable desktop format suitable for scaleup. Developed with renewable material manufacturing at its heart.
– The reduced cost, size and complexity of this test, along with its important sustainability angle, has since allowed us to approach a wider spectrum of companies about entering into a partnership to bring the MicroFlex technology to market.
What is your perspective on the potential of MicroFlex in distributed testing, and which biomarkers do you believe it will be most effective for?
– The key advantages of the MicroFlex system enable a wide range of immunoassay tests that currently only run in the central lab to be ported to the point of care – the fact that the MicroFlex system already replicates most of the key steps of those existing workflows means the effort required to undertake this translation can be reduced – providing a quicker and cheaper route to companies with existing central-lab assays to put them at the point of care.
»The key advantages of the MicroFlex system enable a wide range of immunoassay tests that currently only run in the central lab to be ported to the point of care.«
– Lateral flow test strips have dominated the low end of the point-of-care immunoassay market for decades – and it is true they provide very reliable, cost-effective testing for a wide range of diagnostic proteins. However, we are beginning to run into their limitations of sensitivity and quantitation as companies look to increase the utility of existing tests. Currently there are not many options available between a lateral flow test and a full-blown central-lab run ELISA test when increases to sensitivity or improved CVs are required.
Distributed testing provides benefits to patients in two primary ways:
– Enabling greater access to diagnostic testing by making it more accessible and convenient for patients.
– Reducing the turn around time for getting a diagnostic result for those tests where time to result is critical in determining the safest and most efficient clinical pathway.
– In terms of particular biomarkers that may be of interest, one can look to existing lateral flow test systems as a starting point which currently offer a range of cardiac, inflammatory and infectious disease (inlcuding animal-borne pathogen) diagnostic tests – all of which may benefit from one way or another from the improved quantitation that a system that MicoFlex could deliver.
– In particular, we are seeing an increasing interest in more reproductive health monitoring – from fertility testing and tracking to pre-natal monitoring through to post-partum disorders and monitoring of perimenopause. Achieving reliable, quantitative, results on these tests will be critical to enable proper monitoring over time whilst maintaining the convenience a distriuted testing solution brings. Similarly, gastro-intestinal testing is becoming more prevalent with an associated desire to increase the reach of existing tests to more people. There is also now increasing optimism that a range of possible neuorological markers can provide real benefits for early diagnosis of Alzheimers disease – being able to offer these tests outside of the hospital environment will be extremely important if they are to reach a wide proportion of the population for widespread monitoring – especially as older patients are exactly those who would most struggle to access testing services far from their homes.
– Where distributed testing is able to provide a faster turn-around side than the equivalent central-lab test, cardiac markers remain a highly desirable target as they can significantly shorten the stays of patients within a hospital if rule-out diagnosis can be made earlier. There are also promising results from a range of different host-response blood-based protein markers for early diagnosis of sepsis – if these continue to develop to become accepted diagnostic pathways then being able to run these markers on a point of care platform with a fast turn-around time will obviously be of critical importance.
Could you provide an update from the ESCMID congress and the interest for MicroFlex POC system?
– TTP had both the original MicroFlex system and the new ecoFlex concept on display during our exhibition at ESCMID this year.
– As previously, we found the exhibition to be well saturated with PCR and LFA systems which we believed helped systems such as MicroFlex stand out and capture interest since it addresses a different market segment which is not currently well serviced by multiple companies.
– A common theme amoung those interested in the MircoFlex platform were people looking for ’the next generation’ in lateral flow testing – companies wanting a way to offer better quantitiation than is often possible with existing LFA strips and readers. The ecoFlex concept helped demonstrate how this technology could provide a test cartridge similar in size, complexity and cost to existing LFA devices whilst offering the sensitivity and quantitation normally reserved for the central-lab tests. For those companies interested in higher sensitivity testing or for those who wished to multiplex many tests – we discussed how the original MicroFlex cartridge could be adapted to provide such a capability. Overall there was a positive reception to the technology and the demonstrated performance to date and we will be following up with the interested companies over the course of the year to explore whether any are at an appropriate point to start entering into disussions about a development partnership.
»Overall there was a positive reception to the technology and the demonstrated performance to date and we will be following up with the interested companies over the course of the year to explore whether any are at an appropriate point to start entering into disussions about a development partnership.«
How would you describe TTP’s strategy for forming partnerships for MicroFlex?
– The diagnostics investment market for the past 2 years has been extremely challenging, a combination of the decline of sales from peak Covid demand continuing to work its way out of the annual reports coupled with the global inflationary shocks and related interest rate rises leading to a significant reduction in available venture-capital and a reluctance from large corporates to make significant investments into new products. It appears as if this situation is beginning to show signs of improving, albeit slowly, this year so we are working to make sure TTP continues to build relationships and remind people of the capabilities and potential of MicroFlex so that we can capitalise on any projects once investment activity starts to pick up again.
– We believe the MicroFlex platform has potentially broad appeal to a range of different companies wishing to enter or improve their offering in the distributed immuno-diagnostic space. As such, we are taking a broad approach to make sure as many potential partners are exposed to the technology as possible. There is a continusouly ongoing activity using TTPs existing contacts within the large, established diagnostic companies to periodically update them about the status of our technology offerings within which MicroFlex continues to feature heavily. These companies typically take longer to engage – often limited internally by timings of multiple competing initiatives – so making sure they continue to be made aware of MicroFlex will help mean if they decide to make a move in that direction they will have knowledge of this fresh in their minds.
– TTP are also actively engaged in seeking and talking to smaller companies, using a combination of marketing (via LinkedIn, blogs, website case studies, presence at congresses, local speaker events, podcasts etc) and existing networks to find companies who may be interested in such a partnership and who also have the resources to make the required investments.
– A final part of our strategy involves work to broaden the geographic focus outside of Europe and the US markets. We are seeing strategic shifts in east-Asian healthcare systems away from the conventionally centralised systems to more distributed testing and as such TTP is finding good initial engagement with a number of companies in that region who are interested in how technologies like MicroFlex can help them make the transition. TTP will be exhibiting at JACLAS again this autumn where MicroFlex will be on show and where we hope to continue existing conversations as well as find new potential partners to introduce the platform to.
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