Several companies have developed, or are currently developing, products for the “point-of-care” molecular diagnostics market. In reality, the molecular diagnostics market is heterogeneous, and few applications are likely to arise truly at the point of care—indeed “point-of-clinic” would be a better description for this market.

Point-of-clinic testing systems range from those designed for near-patient testing to those that are suitable for testing in decentralised hospital and clinic settings. Applications may also arise in the developing world where portable systems providing true clinical quality results at a favourable cost are required.

But while several established molecular diagnostics companies have invested considerably in the development of decentralised testing platforms, and considerable growth of the market is expected, a number of barriers to entry and open questions about the market remain.

In terms of fundamentals, there are questions about applicability and the commercial case for point-of-clinic testing:

Applicability — Does the diagnostic test need to be undertaken near the patient? There are some applications where speed of result is key or can provide market advantages, such as sepsis diagnosis or warfarin pharmacogenomics, but others do not need such rapid turnaround.

Commercial — Some of the challenges in terms of decentralisation of facilities are commercial. Demonstrating value above that of sending samples to centralised suppliers, is a key consideration in entering this market, and there is uncertainty just how much decentralisation will occur.

Beyond this, more practical issues also need to be considered with respect to decentralised systems. These include:

Reliability and serviceability — most systems are still relatively complex with many moving parts and associated demanding manufacturing tolerances. This implies high manufacturing costs that need to be traded off against reliability and serviceability.

Cost per test and per unit — Related to the above, this is a key consideration; there is a risk of trying to offer too much within a single device, that may lead to a complex disposable that is challenging and costly to manufacture and reduces the number of tests that are commercially viable on the platform.

In particular, where a product is designed solely to undertake a specific multi-analyte and multiplex test, the commercial reality of matching the cost and complexity of the instrument and disposable to the available reimbursement needs to be considered. Clearly, in oncology there are definite benefits in multiplex assays that analyse multiple protein and xNA markers; yet, the question of when and where one would need a “point-of-care” type result remains.

Footprint and flexibility — In the future “Point of Clinic” lab, one can imagine space constraints being a consideration. This applies to both disposable cartridge storage, especially if it needs to be refrigerated or frozen, and to the instrument. This question may also extend to the number of instruments required to address a range of test types.

Ease of translation — Having available a route to reliably replicate existing lab tests on a point-of-clinic platform with clinical quality is essential. Any new testing platforms need to provide a route for rapid translation form a test being undertaken on a robot or in the lab with a pipette to a fully integrated disposable and instrument.

Given the heterogeneity of the molecular diagnostics market, it is unsurprising that different application-specific point-of-care systems have been developed.

In the (nucleic acid) molecular diagnostics space, both established companies — Cepheid (with the GeneXpert Omni), Roche (through the acquisition of IQuum) and Biomerieux (with Biofire) — and a number of mature start-ups are represented. Atlas Genetics are focusing on STD clinics as a lead application and companies such as Biocartis (Idylla™) and QuantumDx (Q-POC™) continue to develop systems.

The protein analysis market is less well defined, although here too considerable market growth may be expected. While a number of distributed tests are undertaken on lateral flow immune assay devices, fewer platforms address the need for clinical quality ELISA in distributed instrumentation.

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Giles Sanders
giles@ttp.com