Market Overview

Emulating The Unthinkable: FDA's Tech Bet With 'Organ-On-A-Chip'

Emulating The Unthinkable: FDA's Tech Bet With 'Organ-On-A-Chip'

Who might have thought that one day the function of an entire organ can be packed into a miniature chip? The human intelligence is transcending past all understanding. And the telling proof for the same emerged recently, with the FDA's announcement that it has begun collaborating with Emulate Inc. to study the company's "Organs-on-Chips" technology in labs at its Center for Food Safety and Applied Nutrition.

Emulate was founded by researchers at the Wyss Institute for Biologically Inspired Engineering at the Harvard University.

The announcement made on April 11 said the FDA intends to use the technology to study the effects of potentially harmful chemical and biological hazards in food, cosmetics or dietary supplements than is now available.

The Technology

The technology uses flexible polymer organ-chips, which contain tiny channels lined with living human cells. These cells of the size of an AA battery are capable of reproducing blood and air flow just as in the human body. Given the translucent nature of the chips, these would help decipher the inner workings of the organ being studied.

Apart from the chips, there are instrumentation and software apps.

Instrumentation: The organ-on-chips is placed in the research system — called the instrument — can recreate the human body's living environment, including blood flow and breathing motions.

Scientists can use the modular instruments to introduce medicines, chemicals and other toxins to the chip's environment to test the organ's response and behavior.

Software Apps: Scientists can extract data that could be collected and analyzed with a modern software, such an app, which is downloadable on a tablet. The software offers the ability to configure cell architecture, tissue-to-tissue interfaces, mechanical forces and the biochemical surroundings, the FDA said.

The study would be initiated with a liver chip, although there is scope for expanding the technology for other making models of other organs such as kidney, lung and intestine.

How Organ-On-Chip Tech Might Help

The chips can be used to see:

  • How our body processes an ingredient in a dietary supplement or a chemical in a cosmetic.
  • How a toxin or combination of toxins affects cells.

This yields information that could be deployed to help assess risks to human health.

"The ultimate goal is to predict how specific organs will respond to exposure to potential chemical hazards found in foods, cosmetics and/or dietary supplements with greater precision than other methods currently being used, such as cell-culture or animal-based tests," the FDA said.

History On Research

Organs-on-chips research has been in the reckoning since 2012, with a public–private collaboration between the FDA, the federal Defense Advanced Research Projects Agency, or DARPA, and the National Institutes of Health, or NIH.

Several universities such as Harvard and the Massachusetts Institute of Technology have been awarded federal grants to pursue research.

Similar Product, Different Technology

Organovo Holdings Inc (NASDAQ: ONVO), a science and technology company, creates functional human tissues using its proprietary 3-D bioprinting technology. This is done with the objective of:

  • Helping biopharma companies and academic medical companies to design and build in vitro tissues for disease modeling and toxicology.
  • Test drugs on functional human tissues before ever administering the drug to a living person — seen as bridging the gap between pre-clinical testing and clinical trials.
  • Creating functional 3-D tissues to implant into the human body to help repair or replace damaged or diseased tissues.

Science and technology have ensured advancement by leaps and bounds. And the organ-on-chips technology and 3-D bioprinting technology have taken this advancement to an entirely new level. These could go a long way in helping humans with organs for transplanting, where there are inordinate delays now due to several procedural formalities involved.

Related Links:

How The Market For Tesaro's Niraparib Plays Out Following Early FDA Approval

FDA 101: What Does 'Orphan Drug Designation' Mean?

Posted-In: Emulate Harvard UniversityBiotech Health Care FDA Tech Trading Ideas General Best of Benzinga


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