The answer: (1) start with a simple assay that really works; (2) finish it by a great engineer team.
There were several multiplex attempts out there, but non become successful commercial product. The reason: the assay they try to automate usually has too many enzymatic steps, and includes too many procedures such as post-PCR clean up and post-hybridization washes. In order to automate an assay, the assay itself must be really simple.
We start with a very simple arm-PCR method that works very well.
Another reason the iCubate automation attempt is successful is because we did not add any uncertainty to the automation process. The cassette is very “low tech”, use only classical mechanics, no microfluidics (we tried and failed), no nanotechnology (we may try when it is ready).
For PCR, we use three independent heaters, just like the old fashioned PCR machine with three water bathes. We even use oil to cover up the reaction to prevent solution from evaporate.
For hybridization, we use proven printed array. Capture probes (with linkers) were printed onto functionalized glass. And we OEM this process by working with a company who is the industry leader.
For detection, we use laser and PMT to gain sensitivity and speed. Whenever possible, we use the “wheels” that invented by someone else. We realized that innovation is not about doing things unique way, but is about to put inventions to use.
Our engineers and assay development scientists interact daily. They do not belong to different departments, there are no communication barriers. We listen to each other and make decisions together, on the spot. But more importantly, we do everything with a “typical customer” in mind. The typical customer is an end user, a lab tech. How would he/she process the sample? What are their concerns? How can we get the results faster and easier? Which step he/she more likely to make a mistake? How can we eliminate that step?
We understand what the customers want: multiplexed, automated, and closed. And that is what we would like to deliver.
Although we may use the words “Diagnosis” or “Diagnostics” in this blog, our products are NOT FDA approved for such uses. We are developing technologies that may eventually have clinical applications, but for now, all our products are for research use only.