The time is ripe for bringing to market a POCT analyzer with a relatively large test menu that can be managed by less skilled operators and requires micro-samples. That seems to be the business model for Genalyte (see: Real-time In Vitro Diagnostic Results at the Point of Care?). Below is an excerpt from an article about this new company:
Genalyte’s cloud-based Maverick Detection System could potentially change how and when doctors order blood draws, altering long-standing clinical laboratory workflows. Anatomic pathologists and medical laboratory leaders may be aware of efforts in the in vitro diagnostics (IVD) industry to perform clinical laboratory tests with smaller quantities of blood....The biomedical diagnostics developer has announced it is readying its new Maverick Detection System (Maverick), which, according to the company’s website, “completes a comprehensive battery of blood tests in the physician’s office with results in 15 minutes.”....[Genalyte's] central lab handles tests that cannot be completed onsite. “At the core of our cloud-based, diagnostic laboratory offering is revolutionary technology that uses silicon photonic biosensors to perform multiple tests off a single drop of whole blood in 15 minutes,”....In a MedCity News article, Cary Gunn, Genalyte’s founder and CEO, said, “There will always be a need for esoteric testing that needs to be referred to a laboratory. But for the vast majority of routine testing, there’s no reason why that can’t be done in the doctor’s office.”
Genalyte is promising rapid POCT results in a physician's office plus the reference lab services of its central lab for more complex tests. It also claims to be able to perform QC on the locally-performed tests in the cloud. I am not exactly sure what this entails but it seems to me to be a reasonable goal. There is definitely a need in the market for a POCT performance of relatively inexpensive tests with rapid TAT. Not only would such testing be welcomed by physician offices but also in the rapidly expanding first tier of our healthcare system, walk-in retail clinics in drug stores (see: Details about CVS' MinuteClinic POCT Strategy) and urgent care centers (see: Cigna Continues to Expand into the Provider Side of Healthcare).
Genalyte seems to have learned a valuable lesson from the vicissitudes of the founder of Theranos, Elizabeth Holmes. The company had a similar business model that flamed out. That lesson being to avoid becoming the darling of the press and to quietly develop an analyzer and business model that meets a key market need. The article cited above is silent on how the data generated by the Maverick Detection System is integrated into the physician office e-records. This gnarly but critical process is often the last thing addressed by IVD companies but a factor that often trips them up in the end. In this new world of healthcare, connectivity is king.
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