Challenges and Opportunities for Translating Medical Microdevices: Insights from The Programmable Bio-Nano-Chip

References

• Noyce R , HoffM. A history of microprocessor development at Intel. IEEE Micro1 (1), 8–21 (1981).
   Google Scholar
• Becker H . One size fits all?Lab Chip10 (15), 1894–1897 (2010).
   PubMed Web of Science ®Google Scholar
• Whitesides GM . The origins and the future of microfluidics. Nature442 (7101), 368–373 (2006).
   PubMed Web of Science ®Google Scholar
• Manz A , GraberN, WidmerHM. Miniaturized total chemical analysis systems: a novel concept for chemical sensing. Sensors Actuat. B1 (1–6), 244–248 (1990).
   Web of Science ®Google Scholar
• Harrison DJ , FluriK, SeilerK, FanZ, EffenhauserCS, ManzA. Micromachining a miniaturized capillary electrophoresis-based chemical analysis system on a chip. Science261 (5123), 895–897 (1993).
   PubMed Web of Science ®Google Scholar
• Yager P , EdwardsT, FuEet al. Microfluidic diagnostic technologies for global public health. Nature442 (7101), 412–418 (2006).
   PubMed Web of Science ®Google Scholar
• Chin C , ChinS, LaksanasopinT, SiaS. Low-cost microdevices for point-of-care testing. In : Point-of-Care Diagnostics on a Chip. IssadoreD, WesterveltRM ( Eds), Springer, Berlin–Heidelberg, 3–21 (2013).
   Google Scholar
• Yetisen AK , AkramMS, LoweCR. Paper-based microfluidic point-of-care diagnostic devices. Lab Chip13 (12), 2210–2251 (2013).
   PubMed Web of Science ®Google Scholar
• Martinez AW , PhillipsST, ButteMJ, WhitesidesGM. Patterned paper as a platform for inexpensive, low volume, portable bioassays. Angew. Chem. Int. Ed. Engl. 46 (8), 1318–1320 (2007).
   PubMed Web of Science ®Google Scholar
• Cheng C-M , MartinezAW, GongJet al. Paper-based ELISA. Angew. Chem. Int. Ed. Engl. 49 (28), 4771–4774 (2010).
   PubMed Web of Science ®Google Scholar
• Martinez AW , PhillipsST, WhitesidesGM, CarrilhoE. Diagnostics for the developing world: microfluidic paper-based analytical devices. Anal. Chem. 82 (1), 3–10 (2010).
   PubMed Web of Science ®Google Scholar
• Martinez AW , PhillipsST, CarrilhoE, ThomasSW, SindiH, WhitesidesGM. Simple telemedicine for developing regions: camera phones and paper-based microfluidic devices for real-time, off-site diagnosis. Anal. Chem. 80 (10), 3699–3707 (2008).
   PubMed Web of Science ®Google Scholar
• Affymetrix, Inc . www.affymetrix.com.
   Google Scholar
• Luminex Corporation . www.luminexcorp.com.
   Google Scholar
• Becker H . Hype, hope and hubris: the quest for the killer application in microfluidics. Lab Chip9 (15), 2119–2122 (2009).
   PubMed Web of Science ®Google Scholar
• Abbott Point of Care Inc . www.abbottpointofcare.com.
   Google Scholar
• Clark TJ , McPhersonPH, BuechlerKF. The Triage cardiac panel: cardiac markers for the Triage system. Point of Care1 (1) (2002).
   Google Scholar
• Yiğitbaşı T . Multiplex immunoassay and bead based multiplex. In : Trends in Immunolabelled and Related Techniques. AbuelzeinE ( Ed.). InTech, Rijeka, Croatia, 351–360 (2012).
   Google Scholar
• Mohammed MI , HaswellS, GibsonI. Lab-on-a-chip or chip-in-a-lab: challenges of commercialization lost in translation. Procedia Technol. 20, 54–59 (2015).
   Google Scholar
• Chin CD , LinderV, SiaSK. Commercialization of microfluidic point-of-care diagnostic devices. Lab Chip12 (12), 2118–2134 (2012).
   PubMed Web of Science ®Google Scholar
• Becker H . Lost in translation. Lab Chip10 (7), 813–815 (2010).
   PubMed Web of Science ®Google Scholar
• Becker H . Mind the gap!Lab Chip10 (3), 271–273 (2010).
   PubMed Web of Science ®Google Scholar
• McDevitt JT , McRaeMP, SimmonsGW, ChristodoulidesN. Programmable bio-nano-chip system: a flexible diagnostic platform that learns. J. Biosens. Bioelectron. 6, e137 (2015).
   PubMedGoogle Scholar
• Jokerst JV , JacobsonJW, BhagwandinBD, FlorianoPN, ChristodoulidesN, McDevittJT. Programmable nano-bio-chip sensors: analytical meets clinical. Anal. Chem. 82 (5), 1571–1579 (2010).
   PubMed Web of Science ®Google Scholar
• Chou J , WongJ, ChristodoulidesN, FlorianoP, SanchezX, McDevittJ. Porous bead-based diagnostic platforms: bridging the gaps in healthcare. Sensors12 (11), 15467–15499 (2012).
   PubMed Web of Science ®Google Scholar
• Shadfan BH , SimmonsAR, SimmonsGWet al. A multiplexable, microfluidic platform for the rapid quantitation of a biomarker panel for early ovarian cancer detection at the point-of-care. Cancer Prev. Res. 8 (1), 37–48 (2015).
   PubMed Web of Science ®Google Scholar
• Jokerst JV , ChouJ, CampJPet al. Location of biomarkers and reagents within agarose beads of a programmable bio-nano-chip. Small7 (5), 613–624 (2011).
   PubMed Web of Science ®Google Scholar
• Jokerst JV , McDevittJT. Programmable nano-bio-chips: multifunctional clinical tools for use at the point-of-care. Nanomedicine5 (1), 143–155 (2009).
   PubMed Web of Science ®Google Scholar
• Weigum SE , FlorianoPN, ChristodoulidesN, McDevittJT. Cell-based sensor for analysis of EGFR biomarker expression in oral cancer. Lab Chip7 (8), 995–1003 (2007).
   PubMed Web of Science ®Google Scholar
• Christodoulides N , De La GarzaRII, SimmonsGWet al. Application of programmable bio-nano-chip system for the quantitative detection of drugs of abuse in oral fluids. Drug Alcohol Depend. 153, 306–313 (2015).
   PubMed Web of Science ®Google Scholar
• McRae MP , SimmonsGW, WongJet al. Programmable bio-nano-chip system: a flexible point-of-care platform for bioscience and clinical measurements. Lab Chip15 (20), 4020–4031 (2015).
   PubMed Web of Science ®Google Scholar
• Christodoulides N , PierreFN, SanchezXet al. Programmable bio-nanochip technology for the diagnosis of cardiovascular disease at the point-of-care. Methodist De Bakey Cardiovasc. J. 8 (1), 6–12 (2012).
   PubMedGoogle Scholar
• Becker H . It’s the economy. Lab Chip9 (19), 2759–2762 (2009).
   PubMed Web of Science ®Google Scholar
• Dittrich PS , TachikawaK, ManzA. Micro total analysis systems: latest advancements and trends. Anal. Chem. 78 (12), 3887–3908 (2006).
   PubMed Web of Science ®Google Scholar
• Mukhopadhyay R . Microfluidics: on the slope of enlightenment. Anal. Chem. 81 (11), 4169–4173 (2009).
   PubMed Web of Science ®Google Scholar
• Kelley SO , MirkinCA, WaltDR, IsmagilovRF, TonerM, SargentEH. Advancing the speed, sensitivity and accuracy of biomolecular detection using multi-length-scale engineering. Nat. Nanotechnol. 9 (12), 969–980 (2014).
   PubMed Web of Science ®Google Scholar
• Simmons GW , McRaeMP, ShadfanBet al. Programmable bio-nano-chip system: an ultra-flexible platform for bioscience and clinical measurements. Proceedings of the 18th International Conference on Miniaturized Systems for Chemistry and Life Sciences (MicroTAS 2014), 2059–2063 (26–30 October 2014).
   Google Scholar
• Floriano PN , ChristodoulidesN, MillerCSet al. Use of saliva-based nano-biochip tests for acute myocardial infarction at the point of care: a feasibility study. Clin. Chem. 55 (8), 1530–1538 (2009).
   PubMed Web of Science ®Google Scholar
• Mukhopadhyay R . When PDMS isn’t the best. Anal. Chem. 79 (9), 3248–3253 (2007).
   PubMedGoogle Scholar
• Vitzthum F , BehrensF, AndersonNL, ShawJH. Proteomics: from basic research to diagnostic application. A review of requirements & needs. J. Proteome Res. 4 (4), 1086–1097 (2005).
   PubMed Web of Science ®Google Scholar
• Zhang Z . An in vitro diagnostic multivariate index assay (IVDMIA) for ovarian cancer: harvesting the power of multiple biomarkers. Rev. Obstetr. Gynecol. 5 (1), 35–41 (2012).
   PubMedGoogle Scholar
• US FDA . Draft guidance for industry, clinical laboratories, and FDA staff: in vitro diagnostic multivariate index assays. ( US Department of Health and Human Services, 1–15 (2007). www.fda.gov/downloads/MedicalDevices/…/ucm071455.pdf.
   Google Scholar
• Go AS , MozaffarianD, RogerVLet al. Heart disease and stroke statistics—2014 update: a report from the American Heart Association. Circulation129 (3), e28–e292 (2014).
   PubMed Web of Science ®Google Scholar
• Heidenreich PA , AlbertNM, AllenLAet al. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ. Heart Fail. 6 (3), 606–619 (2013).
   PubMed Web of Science ®Google Scholar
• McRae MP , BozkurtB, BallantyneCMet al. Cardiac ScoreCard: a diagnostic multivariate index assay system for predicting a spectrum of cardiovascular disease. Expert Syst. Appl. 15 (1), 136–147 (2016).
   Google Scholar
• Elango JK , GangadharanP, SumithraS, KuriakoseMA. Trends of head and neck cancers in urban and rural India. Asian Pac. J. Cancer Prev. 7 (1), 108–112 (2006).
   PubMedGoogle Scholar
• Jemal A , SiegelR, WardEet al. Cancer statistics, 2006. CA Cancer J. Clin. 56 (2), 106–130 (2006).
   PubMed Web of Science ®Google Scholar
• Silverman S Jr . Demographics and occurrence of oral and pharyngeal cancers. The outcomes, the trends, the challenge. J. Am. Dent. Assoc. 132 (Suppl.), S7–S11 (2001).
   PubMedGoogle Scholar
• Organization WH . mHealth: new horizons for health through mobile technologies: second global survey on eHealth (2011). www.who.int/goe/publications/goe_mhealth_web.pdf.
   Google Scholar
• West D . How mobile devices are transforming healthcare. Issues Technol. Innov. 18 (1), 1–11 (2012).
   Google Scholar
• Citron P . Medical devices: lost in regulation. Issues Sci. Technol. 27 (3), 23–28 (2011).
   Web of Science ®Google Scholar
• Schully SD , BenedictoCB, GillandersEM, WangSS, KhouryMJ. Translational research in cancer genetics: the road less traveled. Public Health Genomics14 (1), 1–8 (2011).
   PubMed Web of Science ®Google Scholar
• Huckle D . Point-of-care diagnostics: an advancing sector with nontechnical issues. Expert Rev. Mol. Diagnost. 8 (6), 679–688 (2008).
   PubMed Web of Science ®Google Scholar
• Sinha SR , BarryM. Health technologies and innovation in the global health arena. N. Engl. J. Med. 365 (9), 779–782 (2011).
   PubMed Web of Science ®Google Scholar
• Floriano PN , AbramT, TaylorLet al. Programmable bio-nanochip-based cytologic testing of oral potentially malignant disorders in Fanconi anemia. Oral Dis. 21 (5), 593–601 (2015).
   PubMed Web of Science ®Google Scholar