Espicom View : ChipCare's product is only in its infancy, while there are other companies with their lab-on-a-chip devices further in the development process andsome even approved. However, ChipCare has stated that its design does make it cheaper than others, which could lead to it being more successful in the long term. The hand held analyser portion of the device is likely to be key in ChipCare's success. So far lab-on-a-chip devices have not been released for HIV; however, the HIV market is being flooded with point-of-care devices, ChipCare will have to prove that its device more effective than these to be successful, and perhaps the addition of other indications in development will make it a more attractive option. A number of the chips that are in development have entered other companies' portfolios through acquisitions; ChipCare is a likely acquisition target if its device is successful.
ChipCare has secured what is believed to be one of the largest ever angel investments in Canada's healthcare sector; CAD 2.05mn in Phase II financing to support the development and commercialisation of a hand-held cell analyser (based on mobile technology) over the next three years.
The financing evolved through a uniquely collaborative funding model among Canadian social angel investors, including Maple Leaf Angels, MaRS Innovation and the University of Toronto, with special financing leadership from Grand Challenges Canada and the Government of Canada. Grand Challenges Canada is funded by the Government of Canada through the Development Innovation Fund announced in the 2008 Federal Budget.
The Phase II project plan calls for a three-year development of the device to further refine its functionality, develop a more robust prototype and reduce costs.
ChipCare believes that its hand-held analyser has the capacity to transform the way in which point-of-care (PoC) diagnostics are delivered in the field for both developed and developing world populations. It stands apart from contemporary tools for three reasons:
• its design makes the analyser significantly less expensive than other similar devices;
• proprietary technology enables test results that are faster and demonstrably more accurate than existing standards; and
• the device enables the potential to run not only one but multiple diagnostics simultaneously.
Adrian Schauer of Maple Leaf Angels, believes that this is at least the second largest healthcare angel investment in Canada's history, and it might well be the largest by the time that the project reaches full maturity. ChipCare is investing heavily in the commercialisation of its product because it sees the potential to revolutionise bedside testing for many conditions, from HIV and malaria in the developing world, to sepsis, heart disease and cancers in the domestic market.
According to ChipCare, each of its tests should cost around CAD 10. This will most likely not include the analyser that is needed to read the test. However, ChipCare believes that some laboratory systems can cost in excess of CAD 150,000.
Lab-on-a-chip devices are becoming a focus for developers of PoC diagnostics, with multiple companies developing these for diseases such as HIV, malaria, TB and tropical diseases. The lab-on-a-chip covers a range of micro and nanodevices intended to rapidly perform chemical, biochemical, analytical, separation or diagnostic operations, often enabling the detection of several diseases at the same time. The development of a lab-on-a-chip depends on the manipulation of small amounts of fluid-based samples. As such, it requires the integrated handling of nanolitre and smaller volumes, as well as operations such as pumping, storage and mixing. Microfluidics is a versatile technology that enables the miniaturisation of complex fluid handling and integrated detection. These devices potentially bring more complicated diagnostic methods to the PoC market.
While these PoC devices will bring diagnostics to areas that do not have access to a laboratory, it will be hard for them to take market share from large laboratory analysers. These systems are already in place, and the reagents and cartridges needed to support them are relatively low cost. These analysers can also be used for a multitude of disease diagnostics, so once they are in place, only new reagents are needed. The only way that a PoC device will be able to compete is to show improved accuracy, cheaper cost in the long term and to diagnose a range of diseases at once. Lab-on-a-chip devices provide more accurate results than other PoC devices that rely on physician interpretation, as they are read by another system, essentially bringing a laboratory analyser to to the field.
PoC diagnostics accounted for 35% of the total in vitro diagnostic market in 2011. With the advent of lap-on-a-chip devices, this may increase. Lab-on-a-chip devices are more likely to have an impact on the diagnosis market than other PoC devices. If lab-on-a-chip technology can match laboratory technology it will be more useful in the field than other PoC devices, a number of which need confirmation and further analysis in a laboratory. However, it is likely that lab-on-a-chip devices will replace other PoC diagnostics rather than taking market share from laboratory diagnostics.
According to Espicom's Point-of-Care Diagnostics: Market Overview report, examples of lab-on-a-chip include OPKO Health's Claros system, which was CE-Marked for PSA testing in June 2010, MycroLab's microfluidic devices for near-patient quantitative diagnosis and Molecular Vision's optical detection technology that is compatible with microfluidic chip technology. In addition, Trinity Biotech has recently entered this market with the acquisition of Fiomi Diagnostics, which is developing a chip-based microfluidic platform to enable quantitative, PoC immunoassay testing in PoC or near-patient settings. Veredus Laboratories is another company with an approved lab-on-a-chip system, there VeraChip, which has so far been approved for three different indications under the brandnames VeraFlu, VereTrop and VereMTB.
The VereChip is an FDA-approved lab-on-a-chip that is designed, developed and manufactured by STMicroelectronics. The silicon chip combines Micro-Electro Mechanical Systems (MEMS) with microfluidics which enables the integration of multiplexed nucleic-acid amplification and detection in a single device. The chip is intended to address the qualitative identification of multiple extracted nucleic acid analytes, through a multiplexed PCR amplification followed by hybridisation on a medium density microarray. This allows the combination of up to hundreds of tests in a single reaction.
ChipCare will be entering a fiercely competitive market, competing against big laboratories, other PoC devices and larger companies developing lab-on-a-chip technology. The only way for this company to make an impact in this market will be to have a device that outperforms others and is competitively priced. The other option would be for this company to be acquired in the future, when its device has been proven.