POC Instruments in Molecular Diagnostics
Irvine, California – In the Molecular Diagnostic (MDx) instrument development market, we are seeing many more opportunities for single point or small multiplex assays in small instruments. These Point of Care or Point of Collection (POC) opportunities are coming from two fronts; applications seeking a platform and a platform seeking applications. But what are the drivers? Why are companies willing to invest in small devices when the centralized testing market is large and profitable?
One reason is simply getting a piece of a very large pie. Smaller companies are competing to get a part of the > $6.5 billion (USD) molecular testing market with a CAGR of over 10% for the foreseeable future. Carving out an even a small niche could result in a big win for a small company. The platform or technology approach to the molecular POC instrument market seems to have the larger risk/reward. Many of the companies who have a platform where they can add applications look to be agnostic in the licensing of their technology to find the quickest win, unless exclusivity proves too big to refuse. The big players in the centralized molecular testing market are investing in POC so they don’t lose market share and can continue to offer a broad portfolio to their customers, a one stop shop so to speak. They invest internally with projects to miniaturize and multiplex current applications, but they also look to the outside with technology assessment experts to find a viable solution. From the application side, we see many Nucleic Acid Tests (NAT) in need of a small instrument to bring the entire solution to market. Traditional qPCR has typically been the preferred method although isothermal applications have started to pick up significantly in recent months. An isothermal NAT could significantly reduce the hardware costs and accelerate instrument development times so this has become very attractive to some.
Another reason for the drive to POC MDx is the lower cost of technology and development. The price of PCBAs, touch screens, and other electronics have significantly dropped in the past decade and created a much lower barrier to entry. Also, the experience in the diagnostic instrument development industry in integrating electronics into small devices has increased substantially. Development time and transfer to manufacturing costs are lower and more competitive. Application companies with limited resources are now able to explore the entire solution rather than relying on general purpose devices already in the market. The same holds true with those companies who have a novel platform for use as a MDx device. These companies can go past proof of concept and quickly into a phase gated development with MDx instrument development companies like BIT.
Decentralization of what were traditionally centralized laboratory test has also played a key role. The push to get MDx closer to the patient has many benefits. As a revenue stream, doctors’ offices, quick clinics, pharmacies, and other points of care can take advantage of the self-pay retail diagnostics market. Although many POC test are reimbursable. Also, the great advantage of MDx is to detect a disease state before a patient becomes symptomatic. Having a POC device at the clinic means results are quick and therapy can be administered before further disease progression. For infectious disease, early diagnosis can ease patient pain, decrease recovery time and slow or stop the spread of diseases. In the case of oncology and prenatal testing, early diagnosis can be lifesaving.
Whatever the internal driver, the results of product development of POC MDx devices ultimately helps clinicians treat patients. The POC MDx market could eventually take a large share from centralized MDx but only if it benefits the patients with quick, reliable and inexpensive information. Until then, there is room for both but the growth is definitely in favor of MDx POC instruments.
Specializing in “Instrumentation for Life,” BIT provides contract product development, manufacturing and after-sales services, as well as hematology instruments, for life science, medical and IVD instrumentation OEMs. Quality and regulatory standards include GMP, FDA registered, ISO13485, QSR and CE IVD Directive. BIT’s global operations in USA, Germany, France & China deliver precision engineered, cost effective systems solutions. Pre-engineered platform technologies reduce development cost and time-to-market; lean manufacturing centers and global supply chain enable competitive product cost.
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