Biomedical Engineering Reference
In-Depth Information
in protein biomarker development. The author explains that the new method does not use
antibodies for making the proteins quantitative. The high specificity is determined prior to
the assay's development. The author points out that the assay development time ranges from
a week to several months (not years). The development cost for the assays can be less than
$2000 per protein.
Lochhead (2009)
recently analyzed a low-cost system for multiple pathogen, POC infectious
disease diagnosis. The author emphasizes that cost effective POC diagnoses are a critical need
for infectious diseases management, especially in resource-limited surroundings. The author
points out that there is a significant gap between the low-cost, single analyte rapid tests that
are in the market, and the multiplexed systems found in clinical laboratories. The author is pres-
ently a vice-president at mBio Diagnostics, and reports that mBio Diagnostics has developed a
robust, low-cost fluidic cartridge and fluorescence imaging system, for POC, multiplexed pro-
tein, nucleic and cellular assays.
Lochhead (2009)
further states that their system leverages
advances in volume-manufactured electronic components and microarray technology.
Olano (2009)
recently analyzed emerging and reemerging diseases. He points out that the
application of molecular diagnostic tools opens up a new era of clinical diagnostics for tradi-
tionally neglected pathogens in the clinical setting. He reports that many diseases remain
alarmingly underdiagnosed due to the lack of commercially available assays. Perkins
(2009) recently addressed the issue of bringing molecular diagnostics toward POC in the
developing countries. The author explains that in spite of the advantages offered by molecu-
lar testing there has been very little impact on clinical care in the developing countries. This
is primarily owing to the cost and the complexity of the test methods. Furthermore, the health
systems in these countries are rather frail. The author examines methods by which infectious
disease diagnosis may be brought to the POC in disease endemic countries.
Finally,
Krieswirth (2009)
recently analyzed developing rapid diagnostics for bacterial
pathogens. The author explains the challenges in developing rapid diagnostics for the identi-
fication and sub-speciation of bacterial pathogens. This could arise from processing diverse
primary samples to providing epidemiological information for infection control to
practitioners. The author points out that the following issues are important in assay develop-
ment: specificity, sensitivity, speed, cost, stability of reagents, reproducibility, scalability,
platform, and ease of interpretation.
References
Analytica-world, Medmira's biosensor division to receive $3 million from ACOA's Atlantic Innovation Fund,
http://www.analytica-world-.com/news/e/60934
,
downloaded April 9, 2009.
Bioportfolio, Genomics awarded $ 9.1 million contract, 2008, Business Communication Company (2005),
RB-159R, Biosensors & bioelectronics, 2008, downloaded April 7, 2009,
http://www.bcc
.
Cambridge Healthtech Institute, Next generation Dx summit: Development, commercialization, clinical adoption
of novel assays, Personal communication (e-mail), March 30, 2009.
