Prolight Diagnostics och TTP har utvecklat Point-of-Care-systemet MicroFlex, med målet att kunna genomföra diagnostiska tester närmare patienten. Systemet möjliggör samma kvalitet som ELISA-tester på centrala labb, men i ett mer kompakt och användarvänligt system anpassat för distribuerade diagnostiska tester. BioStock kontaktade Ben Metcalf, konsult på TTP, för att få veta mer om MicroFlex och varför det kallas “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.

Medan Prolight Diagnostics har fokuserat på utvecklingen av POC-systemet Psyros för mätning av troponin, har dess utvecklingspartner TTP arbetat med utvecklingen av MicroFlex. POC-systemet skulle kunna användas för mätning av biomarkörer inom en rad olika områden, till exempel inflammatoriska och infektionssjukdomar, reproduktiv hälsa, gastrointestinala tester samt kardiologiska och neurologiska markörer.

Sedan 2022 har Prolight och TTP ett kommersialiseringsavtal där TTP är ansvariga för pågående externa initiativ och diskussioner för att säkra en industriell partner för MicroFlex. Enligt kommersialiseringsavtalet kommer Prolight att få ersättning när framtida intäkter genereras.

Utvecklingen påverkas inte av nedskrivningen

TTP ser stor potential i MicroFlex-systemet för flera biomarkörer, men Prolight anser att sitt Psyros-system har större potential för specifikt troponintestning. Därför har Prolight nyligen beslutat att skriva ned kapitaliserade utvecklingskostnader för troponintestning med MicroFlex-systemet med 113 Mkr.

– Bakgrunden till nedskrivningen är MicroFlex-systemet inte längre anses vara lika lämpad för testning av den enskilda biomarkören troponin, eftersom Prolights digitala POC-system Psyros har visat överlägsen prestanda. Nedskrivningen är därmed något vi är tvungna att göra enligt fastställda redovisningsprinciper.

– Det kommersialiseringsavtal som tecknades med TTP i november 2022, påverkas inte av beslutet då det omfattar flera andra biomarkörer som bedöms ha stor marknadspotential.  TTP fortsätter att driva utvecklingen mot kommersialisering.

MicroFlex möjliggör testprestanda som för ELISA-test

MicroFlex-systemet är ett användarvänligt immunodiagnostiskt system för mätning i helblodprover, med ambitionen att leverera samma testprestanda som ELISA-teknologin på stora sjukhuslaboratorier. Detta gör att systemet lämpar sig för ”distributed testing”, det vill säga att flytta testprocessen från de stora centraliserade laboratorierna närmare patienterna.

ELISA (Enzyme-Linked Immunosorbent Assay) är en vanligt förekommande laboratorieteknik för att detektera och kvantifiera ämnen såsom proteiner, peptider, antikroppar och hormoner. Metoden bygger på en specifik bindning mellan ett antigen och en antikropp, i kombination med en enzymatisk reaktion för att producera en mätbar signal.

Lätt att använda och snabb

MicroFlex-plattformen kombinerar ELISA-analysteknologin i ett microformat med Flex Membrane-teknologin utvecklad av TTP. Kombinationen av dessa teknologier har potential att uppnå likvärdig testprestanda, men i ett enkelt format väl anpassat för distribuerade diagnostiska tester.

MicroFlex gör det möjligt att utföra ELISA-test med ett litet engångstestkort. Systemet har en inbyggd centrifug och dessutom kan testkortet laddas direkt med provtagningsröret, vilket förenklar testprocessen avsevärt. Därmed möjliggör MicroFlex ett snabbare och enklare alternativ för att mäta ämnen i blodet jämfört med att utföra analysen med en mikrotiterplatta.

EcoFlex – nytt miljövänligt testkort

TTP har nyligen utvecklat ett nytt, mer miljövänligt testkort som kallas ecoFlex. Testkortet bygger på samma underliggande MicroFlex-teknologi, men baseras till stor del på återvunnen pappersmassa, vilket resulterar i 95 procents minskning av plastanvändningen jämfört med MicroFlex (som är designad för högvolymsvätskebearbetning).

Testkortet ecoFlex kan tillverkas med mindre än 2 gram plast, men kan fortfarande leverera ELISA-resultat av laboratoriekvalitet. Testkortet har en målkostnad på under 1 USD och konkurrerar därmed med så kallade lateral-flow strips, som är mindre känsliga och som resulterat i stora mängder plastavfall.

MicroFlex visas upp på kongresser

TTP letar nu efter partners som vill driva vidare utveckling och kommersialisering av POC-plattformarna MicroFlex eller ecoFlex. För att uppnå detta mål har TTP visat upp MicroFlex-systemet för potentiella partners på olika kongresser; senast på European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2024 i Barcelona, och snart på ADLM 2024 i Chicago mellan 30 juli och 1 augusti i år.

En av representanterna från TTP på ESCMID var Ben Metcalf, som är konsult på TTP. BioStock kontaktade Ben Metcalf för att få veta mer.

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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