Biomedical Engineering Reference
In-Depth Information
THE CMI device uses a simple quartz crystal element and can be powered by standard
batteries. The device permits the medical doctors to make instant, accurate, at-the-bedside
or in-the-field medical diagnoses from blood or other samples.
CMI emphasizes the advantages of being able to diagnose one's own viruses which lead to
benefits for the consumer under the healthcare system. Their founder and managing director
Dr. Matthew Cooper insists that CMI's focus on low cost, high performance tools involves
slightly high risk, but likewise the rewards are high. He adds that the Life Sciences tools mar-
ket is £2 billion (equivalent to U.S. $2.93 billion) and the diagnostic market that they are
aiming at is £45 billion (equivalent to U.S. $65.92 billion).
CMI will focus on the home diagnostic OTC (over-the-counter) devices. Emphasis will be on
infection detection. Dr. Cooper adds that it will take around 12 months to obtain regulatory
approval for both Europe and the United States once the necessary R&D is finished. Inciden-
tally, the technology which is the basis for CMI was developed in the departments of Chem-
istry and Pathology of the University of Cambridge.
Cambridge Healthtech Institute (CHI) (2009)
in a personal communication about their confer-
ence titled, “Next generation Dx summit: development, commercialization, clinical adoption of
novel assays,” reports that molecular diagnostics is the fastest growing segment of the IVDmar-
ket. They point out that the clinical application of molecular diagnostics to identify, diagnose,
and monitor infections, cancer, and other diseases has made molecular diagnostics a strong
player in healthcare. Furthermore, the range of utility of POC testing is broad, and includes
influenza, HIV, emerging pathogens, cardiology, stroke, and even cancer applications. They
further explain that the demand for automated and integrated systems and the number of players
is growing exponentially. Also, gene expression panels from microarray data and the next gen-
eration sequencing are being used for the early detection and prognosis of cancer. The impor-
tance of sequencing has been mentioned earlier. CHI further explains that coupling molecular
methods with advances in nanotechnology, microfluidics, information technology, and fabrica-
tion will all lead to newer platforms that continue to emerge in the detection and diagnosis of
infectious diseases. They further point out that to make these tests reach the market clinically
useful tests that are well validated and standardized need to be developed.
Finally, the medical community needs to clinically adopt these novel types of tests based on
molecular diagnostics. The process by which these tests may be adopted were to be explored
at the conference which was to include comments and lectures by the medical and regulatory
community. Regulatory requirements are continuously changing, and the earlier one is aware
of the major changes that are involved, the sooner one may modify one's development pro-
cess for the diagnostic device, thereby helping to save precious resources, such as time and
money. One may also help save time-to-market also.
Pisano (2009)
describes a new method to develop protein assays called peptide MRM. This
method, the author claims is quickly being realized as a solution to the current bottlenecks
