What Will Be Your Next Move in the In Vitro Diagnostic Space

When it comes to in vitro diagnostic (IVD) technologies, medical device and diagnostic companies have been chomping at the bit to produce the next big innovation. The last few years have seen a surge in IVD technologies in the market, as device makers expand their knowledge and resources surrounding IVD technologies.

With new products in the marketplace for direct-to-consumer tests (DTC), point-of-care diagnostics, and next-generation sequencing, we may be on the threshold of a new wave of diagnostic technologies that could have an impact on other diagnostic areas as well, such as gene sequencing and editing. These new IVD technologies could potentially be the key that unlocks the door for a whole new generation of diagnostic possibilities.

In an effort to explore some of the latest IVD technologies, as well as the trends that paved the way for them, Bill Harries, chief scientist at, Aromyx a medical technology company that focuses on capturing human olfactory and taste receptors on a disposable biochip for different therapeutic applications.

Harries earned his PhD in human anatomy and cell biology from Wayne State University School of Medicine and has spent the last 30 years researching integral membrane proteins in an effort to help design, express, and incorporate the human olfactory and taste receptors into a scalable sensor platform. He’ll also be part of a panel discussion at the BIOMEDevice San Jose Conference in December on the topic, "Your Next Move in the IVD Space: Is Merging, Mixing, and Matching in IVD Still the Rule?"

 IVD technologies that sense or detect changes in the body from outside the body could have quite an impact. For instance, sensors that can detect high intraocular pressure without having to touch the eye or measure blood chemistry without piercing the skin are certainly worth keeping an eye on in the coming months ahead.

 
How do you think gene sequencing and editing technologies like CRISPR will have an impact on IVD products and technologies? Harries said, I think that CRISPR technology will play a significant role in IVD product development in the near future. The capabilities that CRISPR can provide will give molecular biologists fast, efficient tools to modify genes of interest, as well as modify biochemical pathways with much more speed and efficiency.
 
Having a non-invasive sample acquisition that does not require the patient to significantly alter their behavior can be a very high attribute. Also, having IVD technologies that provide coverage of diseases and health conditions that have not had adequate diagnostic tools developed to date could also be of very high value.

 
What do you think are some of the biggest challenges facing IVD innovation? How do you think that these challenges can be overcome to help produce exciting next-gen technologies?

 
Harries said, I think the regulatory environment must become an ally to innovators, rather than being a hindrance. Getting investors to commit to significant funding is hard when they know that much of their investment will be consumed in multi-year hoops that have to be jumped through. Refinement of the testing/validation process will take a concerted effort by all involved to achieve significant reductions in the time-to-market, but here doesn’t seem to be the will to make it happen on the regulatory side. One reason for this is that the regulators don’t have much skin in the game. Significant increases in small business innovation research funding would go a long way to help small, agile innovators take academic and private research innovation to the development and validation stage.