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A UK-based SME has developed a point of care (PoC) testing device that measures blood clotting time. This technology provides the accuracy of the laboratory gold standard test with the convenience of a PoC device at low cost enabling patients to better manage their medication and condition. The SME is looking for partners to help with the final phase of development, commercialisation of the device including the manufacture and distribution under a joint venture or a manufacturing agreement.
The number of patients being treated with anti-coagulation (blood thinning) medication such as warfarin is increasing, a trend that looks to continue. As each patient reacts to this medication differently they need to have regular testing of Prothrombin Time (PT) or International Normalized Ratio (INR) to ensure that the dose of this medication is adjusted to remain within the therapeutic range. Currently these tests are done within clinical laboratories which does not provide a patient with a convenient way of managing their medication. There are a limited number of point of care coagulation testing devices available but the market is dominated by a single device in which an electrochemical measurement is taken and an estimated PT/INR time is calculated. This methodology is not as accurate as the laboratory based methods which measure physical clotting time. There is therefore a need for a point of care device that can measure coagulation time that can be used by the patient to manage their own medication conveniently but provides the accuracy of a laboratory based method.
A UK-based SME has developed a point of care testing device that measures blood clotting time semi-mechanically. The proprietary test has patents granted in the US and China with additional patents filed in the EU. It uses microfluidic chambers in a disposable test strip. A particle is spun by magnetic induction in test and reference chambers which are filled with a finger prick blood sample. Particle spin is detected and processed to determine clotting time. The technology has been successfully tested in a hospital setting with anonymous patients against the gold standard laboratory test where it proved to have the same accuracy and excellent reproducibility (coefficient of variance of 5%). This device/technology combines the convenience of a point of care device with the accuracy and reliability of a laboratory based test. This is also provided at lower costs than the currently available market leading point of care device.
The company is now looking for partners to help with final phase of development (meter unit) and commercialise this technology. In particular they need partners operating in the medical device and diagnostics space with experience of point of care devices who can manufacture and distribute the UK SME's device and assist with the commercialisation process. It is envisaged that the partnership will take the form of a joint venture or a manufacturing agreement.
The UK SME's point of care coagulation testing device has the innovation of miniaturising a reliable technology to provide the accuracy of a laboratory test in a hand-held point of care device. It also provides the following advantages:
Cheap cost - the device itself is expected to cost one third the price of the market leader with the associated test strips approximately half the cost.
Reliability - the device has performed extremely well in terms of accuracy and reproducibility of results in comparison with the gold standard laboratory test.
Speed - results can be obtained in less than three minutes.
Flexibility - the functional component of the device can be placed into a device housing of almost any size, shape of form enabling it to fit within an existing product range.
Other Coagulation tests: this device is also capable of other Coagulation tests such as activated partial thromboplastin time, APTT.
The UK SME is looking for industrial partners that operate within the medical device and diagnostics space and especially those with experience of the point of care area. The SME offers the coagulation testing technology and requires the partner to help with the commercialisation process including manufacture and distribution. Ideally they would like to partner with a company that has manufacturing capabilities and a good distribution network It is envisaged that this partnership will take the form of a joint venture or a manufacturing agreement.