News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Interesting technology could be incorporated into medical laboratory tests

Though still in early development, “SmartPills” —a technology now being adapted for therapeutic drug delivery and monitoring—could be used in ways that bring pathologists into closer consultation with primary care physicians.

Using new drug-delivery technology created by California-based Proteus Biomedical, the SmartPill sends information from inside the patient’s body to a chip that’s worn outside on the skin in a patch, or embedded under the skin. The chip then uploads the data to a Smartphone or through the Internet to the prescribing physician.

Take Your Pills, Please!

The purpose of this innovation is to get patients to take their medications. Pharmaceutical companies lose billions of dollars each year when patients with long-term illnesses fail to take their medications as prescribed. This explains why Pharma giants like Novartis AG (NYSE:NVS) would be interested in acquiring and using technology such as the SmartPill. Novartis announced that it is purchasing the exclusive licenses and options for all of Proteus Biomedical’s drug-delivery technologies.

In doing this, Novartis becomes the largest pharmaceutical company to pursue SmartPill technology. Novartis is also the same company that, earlier this year, paid $470 million to acquire pathology testing company Genoptix, Inc., (See Dark Daily, “Novartis To Pay $470 million To Buy Pathology Testing Company Genoptix,” January 25, 2011.)

Attached to a prescription drug pill, the digestible chip gets activated when it comes in contact with stomach acid. It then reports to the prescribing physician the time when the patient swallowed the pill to which the chip is attached. It can also note and report any adverse reactions.

According to an article in Reuters, Novartis plans to add the microchip to the drugs that are taken by transplant patients to prevent organ rejections.

“We are taking forward this transplant drug with a chip, and we hope within the next 18 months to have something that we will be able to submit to the regulators, at least in Europe,” said Trevor Mundel, Global Head of Exploratory Clinical Development for Novartis at a Reuters Health Summit in New York.

Trevor Mundel, Global Head of Exploratory Clinical Development, Novartis

“I see the promise as going much beyond that,” Mundel added.

Mundel expects Novartis to eventually include the microchip with other drugs. The Proteus chip, according to Mundel, can collect a plethora of biometric data, including body temperature and heart rate. And since the chips will be added to existing drugs, full-scale clinical trials are not necessary, which should bring the drug-delivery technology to market relatively quickly.

The bigger picture issue has to do with privacy. In both the U.S. and in Europe, regulations require that a patient’s privacy be protected during any wireless transmission containing private patient data.

“The regulators all like the concept [of SmartPill]—and have been very encouraging—but, they want to understand how we are going to solve the data privacy issues,” said Mundel in the Reuters article.

A Disruptive Innovation That Might Have Uses in Clinical Laboratory Testing

The SmartPill is not the only such system under development intended to improve the delivery of drugs in the body, or assist patients in remembering to take their medications.

  • Royal Philips Electronics in 2008 developed the “iPill” or “intelligent pill,” which delivers drugs to specific spots in the digestive tract, to battle Crohn’s disease, colitis and colon cancer.
  • MicroCHIPS Inc., in Waltham, Massachusetts, has developed implantable microchips that “store, protect, and precisely control the delivery of highly concentrated proteins and peptides.”
  • Cambridge-based Vitality Inc.’s GlowCaps fit common prescription drug bottles and include a chip that 1) rings and flashes to remind patients when to take their drugs, 2) sends weekly emails to a designated friend or family member who then, presumably, reminds the patient to take their drugs, 3) orders refills, and 4) sends a printed report monthly to physician and patient.

Dark Daily points out that the story here is more than simply about prescription pills that can transmit information to the physician as they journey through the patient’s digestive tract. This technology enables a real-time reporting of what the sensor is reading while inside the body.

Clinical laboratory managers and pathologists might want to consider how these real-time in vivo monitoring technologies could be adapted for use in clinical laboratory testing. By combining digital, wireless and cell phone technologies, developers of the new drug-delivery systems have simultaneously invented a technology base that could be used to create new “lab test” systems. This, in turn, brings pathologists closer to the realm of active patient monitoring and primary care.

—By Michael McBride

Related Information:

Potential Encapsulated (The Economist)

Look Out, Your Medicine is Watching You (Reuters)

Novartis’ “SmartPill” May Be “Watching You” by 2012 

Novartis to Pay $470 million to Buy Pathology Testing Company Genoptix