Why is the molecular diagnosis not seeing the Killer App?

Release date: 2014-06-10

Many biotech companies, including Promega, which I have just visited, and several diagnostic companies that have recently met in the country, are very concerned about molecular diagnostics. But when it comes to molecular diagnosis, people feel confused or disappointed, because there are no eye-catching masterpieces, and there are no Kinder App like Word, Excel, PPT in the IT industry. why?
First of all, we have to look at what kind of application can be regarded as the Killer App (KA). I think that the so-called KA is "an app that many people use every day." Not many people can't use it, not every day. There are millions of apps on the iPhone, and how many apps like WeChat?
In the past two or three decades, under the monopoly of Roche's PCR technology, the results of molecular diagnostics are countable. qPCR quantitative detection of Viral Load can be a good application, and some companion diagnostics are also some good applications, and some are molecular diagnosis of infectious diseases. However, the market for these diagnoses is very limited, and it is not really a Killer App. In detail, the reasons for the lack of the Killer App are technical, and many are market-oriented.
The premise of KA is useful, and the biggest problem facing molecular diagnosis is practicality. Many pathogen diagnosis has no guiding significance for doctors, no actionable information, or little clinical significance. It is not impossible to completely replace the existing methods, or the information provided has no immediate guiding significance for doctors to treat patients. There is no real guiding significance for the clinic, it is not an "app that is used every day."
At the technical level, the molecular diagnostic threshold is too high, and trained researchers are required to complete the experimental steps of nucleic acid extraction, amplification, and detection. Moreover, the requirements for hardware are also high, including instrument investment and laboratory environment construction (to prevent false positives caused by contamination of amplification products). These technical barriers have made molecular diagnostic techniques inaccessible to "many people."
App with universal applicability has the opportunity to become a KA. An application, if it is used every day like WeChat, becomes a part of life, then there is a chance to become KA. However, in reality, the first reaction after a doctor receives a report on molecular diagnosis is usually "so what?", indicating that the technology is still far from KA.
So why is molecular diagnosis often given just a "so what" answer?
The reason is actually very simple. Because the core technology of molecular diagnosis is PCR, and conventional PCR, including qPCR, is a specimen, a reaction, and an indicator. The most useful clinically for doctors is differential diagnosis. The purpose of a single diagnosis is often to prove a certain guess of the doctor, and the differential diagnosis can provide actionable information. The differential diagnosis needs to analyze, compare, and eliminate multiple possibilities at the same time, and finally find a feasible solution.
The high-throughput sequencing technology is so exciting that it is widely believed to provide a wealth of relevant information for differential diagnosis.
In fact, whether it is high-throughput or "low-throughput", the KA way out for molecular diagnosis is to find a "everyone uses it every day." Our iCubate2.0 technology platform is a platform technology that can meet this demand.
In order to make "everyone can use", we have made hardware diagnostics greatly reduce the professional level requirements of operators through hardware integration. Together with the fully enclosed design, the requirements for the laboratory environment are reduced. This is the "democratization of molecular diagnosis", which allows molecular diagnosis to go out of research institutions, large hospitals, and community hospitals and family clinics in remote areas.
In order to be a "everyday" technology, our multiplex PCR technology can simultaneously analyze many genes. For example, we are doing clinical trials to declare the US FDA's Sepsis reagent, which is to detect multiple pathogens that cause nosocomial infections, including the resistance genes often carried by these pathogens. Thus, after the multiplex PCR experiment, the doctor's information is not only "the patient has a S. aureus infection", but "the patient's S. aureus infection can be treated with (or can not be used with) a certain drug."
In-hospital infection is only the beginning, and there are more KAs that we need to develop together, and more needs are not being met.
Of course, another prerequisite for the Killer App is the popularity of the hardware, the iPhone, and the Android phone. This is not available on our iCubate technology platform. After all, the question "Is there hardware first? Or is it KA first?" is the typical "first chicken or egg first?" question. The market does not ask which first, which after, the market requires both.
However, I believe that as long as we seriously solve the problem of "everyone can use" and "general usefulness", we are not far from the molecular diagnosis of KA.

Source: Entropy

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