Today, clinical laboratory tests are either performed on large automated analyzers in a central laboratory or on point of care instruments. Centralized automated instruments have the advantages of lowest cost per test, excellent test performance, direct interfaces to laboratory information systems and electronic medical records. Point of care instruments have higher cost per test and are more difficult to interface, but provide faster turnaround time.
Most of the conventional laboratory instruments are manufactured by a small number of companies including Abbott, Roche, Siemens, Beckman Coulter and Ortho Diagnostics. Companies that are less familiar to laboratorians are developing exciting new disruptive innovations that will drastically change clinical laboratories in the future. Theranos has received the most press for its claims of multiplex testing on a single drop of blood. However, its technology remains shrouded in secrecy and has not been validated. Below is a list of some of the current front-runners.
- Biomeme is developing a smartphone enabled qPCR to identify microorganisms
- Holomic Rapid Diagnostic Reader has minaiturized lateral flow immunoassays
- Sano Intelligence is developing a wearable transdermal patch for basic metabolic panels
- Biosense Technologies has a mobile phone app called UChek for urinalysis
- DxUpClose detects bacteria in urine and determines antibiotic sensitivity
- Cue has a modular home test for influenza, vitamin D, testosterone, LH and CRP
- Segeterra is developing the InsideTracker for blood analysis
- OPKO Diagnostics has the mChip for rapid HIV testing
- DNA Medical Institute (DMI) won the NokiaSensing X Challenge for its multiplex array that can detect hundreds of biomarkers
- Archimej Technology was a finalist in the NokiaSensing X Challenge for measurement up to 20 biomarkers on a single drop of blood
- OJ-Bio uses sonic acoustic wave technology to detect multiple viruses.
- NanoMal has an inexpensive test for malaria diagnosis
The marriage of microfluidic lab on a chip technology with smartphones promises to disrupt laboratory practice in the near future. These instruments will decentralize testing and improve patient access to laboratory services. They will also provide universal access to test results through true wireless technology.