A PAT on the back

Roche to use Itamar Medical’s EndoPAT device to measure peripheral artery tone in cardiovascular drug development

Lloyd Dunlap
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CAESAREA, Israel—Itamar Medical will develop an EndoPAT device designated for use by Roche with animal models, enabling preclinical studies examining the efficacy of various compounds in the early stage of drug development. The EndoPAT device is a non-invasive technology designed to diagnose and monitor endothelial dysfunction, which constitutes an early stage of cardiovascular diseases in humans.

"Following on from our work with Roche in clinical studies, we are pleased to further our collaboration that will reinforce our strategy of EndoPAT playing a major role in developing personalized medicine and companion diagnostics," says Dr. Dov Rubin, Itamar Medical's president and CEO.

Scientists from Itamar and Roche met several years ago at a major cardiology conference, explains Dr. Koby Sheffy, Itamar Medical's CTO and senior vice president.

"Once links were established, I was invited to give a lecture at Roche on the PAT technology. We then initiated a small scale study, and the rest, as they say, is history," Sheffy says.

The two companies collaborated first on a small-scale study in humans, mostly for Roche to get hands-on experience with the technology. 

"This time around, the goal is to develop a device based on the EndoPAT technology for an animal model to be later used in preclinical studies where compounds are tested before entering trials in humans," Sheffy states. "Roche is sponsoring the development, which will be done by Itamar."

Sheffy points out that Itamar's patent-protected technology has been deployed in nearly 20 large-scale drug development studies—all in human placebo-controlled, multicenter clinical-phase trials with either existing or new drugs to measure their ability to reverse endothelial dysfunction.

"EndoPAT offers the only non-invasive, FDA-cleared technology for detecting endothelial dysfunction that is easily applied and totally operator independent in humans," he says, "which positions it as the technology of choice to assess endothelial dysfunction in cardiovascular drug development from the early animal model through the different clinical phase trials in humans."

The PAT signal is measured from the fingertip by recording finger arterial pulsatile volume changes. Based on PAT Technology, the noninvasive EndoPAT system comprises a measurement apparatus that supports a pair of modified plethysmographic biosensors. The unique feature of the PAT biosensors is that they impart a uniform sub-diastolic pressure field to the distal two thirds of the fingers including their tips. Applying the pressure in this way prevents distal venous blood pooling that can induce a veno-arteriolar vasoconstriction reflex and unloads arterial wall tension, which generates a greater dynamic range of the measured PAT signal. An important advantage of the EndoPAT technology is its independence from operator influence over results.

"The other non-invasive technique of assessing endothelial function is FMD (flow mediated dilatation) where measurements are done using ultrasound of the brachial artery. This is a very operator-dependent technique where one needs to have much expertise (finding the right location, not losing the image, not applying too much pressure, etc.) and still the way it is performed can very much affect the result," Sheffy says. "EndoPAT utilizes two thimble-like sensors mounted on the index fingers and everything is controlled and run by a PC—no human hand is involved—and thus, it is totally operator independent."

Sheffy notes that the technique is useful in a wide range of disease states, including coronary artery disease, type II diabetes, hypertension, sickle-cell disease, erectile dysfunction and metabolic syndrome.

Roche taps Expression Pathology for cancer research programs

ROCKVILLE, Md.—In January, news also came that Roche has entered into an agreement with Expression Pathology Inc., a developer of multiplexed SRM assays for major cancer signaling networks, in which Expression Pathology will provide its Liquid Tissue-SRM Technology to accelerate identification of cancer molecular markers.

Under the terms of the agreement, Expression Pathology will support Roche's oncology drug development programs with multiplexed quantitative assays of cancer signaling pathway proteins and their activation in FFPE tissues by mass spectrometry.

According to Expression Pathology, the Liquid Tissue-SRM platform makes possible highly multiplexed protein quantitation by powerful mass spectrometry of minute amounts of laser microdissected FFPE tissue.

"This new approach to tissue analysis has the potential to dramatically streamline and improve biomarker identification in FFPE samples during clinical development," says Dr. Miro Venturi, senior biomarker and experimental medicine leader at Roche. "Longer-term, we may envision Expression Pathology's Liquid Tissue-SRM platform as becoming a new way of profiling tumors at the molecular level to improve patient stratification and therefore advancing our discovery of personalized medicines."

Lloyd Dunlap

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