Results from blood tests heavily influence the diagnosis and treatment decision-making for doctors and other health care providers whether these tests are ordered for disease detection (an acute illness or injury) or health monitoring for a chronic condition like diabetes.  When the U.S. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 to regulate laboratory testing, a massive consolidation of diagnostic testing services limited access to routine and critical lab testing to large, centralized laboratories.  “Near patient” testing nearly vanished in the U.S. and similar regulations had the same effect in Europe.  Read More

The current system is failing

For those of us fortunate enough to be located in areas with highly developed healthcare services, we find ourselves being shuffled through a fragmented healthcare delivery system designed to minimize cost rather than maximize value.   Every day, patients spend hours driving to and waiting for appointments only to be asked to wait even longer for critical health information that will help diagnose illness and direct the correct treatment decision.  In a technological chase to generate the cheapest test, we have lost the efficacy of our overall healthcare system and left enormous gaps in accessibility.  With diagnostics representing only 2% of all healthcare expenditures, we have literally spend thousands of dollars to save pennies all while placing a heavy burden on physicians and patients.

New technology paradigms for healthcare delivery

While distributed information technologies (world wide web, laptops, smartphones) have transformed business and society around the world, healthcare hasn’t caught up with this decentralization of technology and information. Distributed diagnostics fully exploits the state of the art healthcare information technology by simplifying diagnostic technology and moving it to the front lines of medicine where it can be adapted to provide high quality and accessible care.  Much like cheap portable computing was leveraged to transform both developed and underdeveloped economies, powerful, small-scale diagnostic systems can be leveraged to transform healthcare globally.  It’s time for healthcare delivery to catch up with the world’s technologies that have miniaturized, unwired, and better integrated products and services previously only available in large centralized environments.

Intelligent design without compromising qualityMGH is leading the development of next generation diagnostics with modular diagnostics (MODx), the most compact high performance diagnostic system ever made.  MODx brings the power of central lab blood testing to the benchtop.  Incorporating patented flow cytometry and photometry technologies, MODx can count cells and provide measurements and determinations for laboratory assays – with results that are indistinguishable from the large central laboratory analyzers used at the Massachusetts General Hospital (MGH).  MODx eliminates the many limitations of point-of-care testing technologies, in particular, limited assay availability, poor assay quality, high per-test cost, and device interoperability with its various components.

shutterstock_70900930Comprehensive testing

MODx is the first system to integrate diagnostic testing across common blood and urine testing platforms.   It is an innovative blood analyzer capable of performing hematology (including the complete blood count with differential count), clinical chemistry, and immunoassays.  What makes this blood analyzer different from the other commercially available “near patient” analyzers is that it performs the testing in a parallel, multiplexed fashion – all from the same, very small, 75 microliter blood sample (about the size of one very large droplet of blood and one-tenth of the blood currently required in central lab testing).

Uncompromized performance

Performance 10022014The engineering team at MGH was given the impossible task of developing a single benchtop system that could replace three large enterprise systems without any loss in analytical quality.  With four years of development, the MGH Center for Technology Development accomplished the impossible.  Click on the graphs to see for yourself.  The results show equivalent dynamic range and performance to the full scale analyzers used in the central laboratory.

Puts the power of the central laboratory in your handsIntelligent design

Moving diagnostic testing to the front lines of medicine requires thoughtful design.  MODx design provides a seamless end-to-end diagnostic solution that is incredibly simple to operate by personnel at all different levels.  The core system’s proprietary “layered modular” design can be packaged in a variety of ways (similar to a rack system).  Envision MODx system in mobile medical units, as the benchtop analyzer for physician’s offices, in telemedicine consoles.   MODx can be reconfigured, upgraded, and easily serviced with its “plug-and-play” modular design.

The new norm for blood testing

Long wait times abound in nearly every facet of today’s healthcare environment.  Patients and families arrive and wait to come to an exam room in the emergency department or doctor’s office, wait to be seen by a physician or nurse, wait for blood tests to be drawn, wait for the blood test results to come back, and then wait to see the doctor for the test results.  Imagine how the patient experience and satisfaction would dramatically improve if you could have your essential blood tests results ready – before you first see the doctor?  What if a nurse or technician could take a tiny amount of your blood when you arrive and get the results back to your doctor and into your medical record in 15 minutes or less?  By the time the doctor comes to see you, the essential laboratory tests are available so that the conversation with your doctor about your likely diagnosis can done rather than waiting for hours or days.

Also, consider blood testing in a small infant or child whose total volume of blood in the body is limited, relative to an adult.  Using traditional blood sampling technologies requiring adult-sized blood samples means very sick children may have to undergo blood transfusions to replace the infant’s blood that has been taken for laboratory testing.   By using MODx, there is no need to replace the miniscule amount of blood lost from constant blood monitoring in this special patient population.

These are just a few of the many ways in which MODx promises to improve your experience as a patient, all of which lead to better patient and healthcare professional satisfaction. 

Relevant publications

Kotz KT, Xiao W, Miller-Graziano C, Qian WJ, Russom A, Inflammation and the Host Response to Injury Collaborative Research Program. Clinical microfluidics for neutrophil genomics and proteomics. Nat Med. 2010 Sep;16(9):1042-7. PubMed PMID: 20802500; PubMed Central PMCID: PMC3136804

Kotz, KT, Petrofsky AC, Haghgooie R, Granier R, Toner M, Tompkins RG.  Inertial focusing cytometer with integrated optics for particle characterization. Technology (Singap World Sci). 2013;1(1):27-36. PubMed PMID: 25346940; PubMed Central PMCID: PMC4206911

Contact

Robert Granier
rgranier@mgh.harvard.edu
617-724-6291

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Grace McDonald-SmithCentral lab testing on the benchtop