Doctors diagnose as many as 60,000 new cases of Parkinson’s disease every year in the United States. Yet diagnosing Parkinson’s with certainty can take years — long after early signs and symptoms have appeared.

The Israeli startup BioShai has a game-changing product on the horizon: PDx, the world’s first simple blood test for the early diagnosis of Parkinson’s.

The test results can be combined with clinical data, providing a more accurate diagnosis to help physicians decide on the best course of treatment at a much earlier stage.

“Having a diagnosis at an earlier stage can lead to a more precise treatment and a higher quality of life for the patient,” said BioShai CEO Jennifer Yarden. “Offering a simple and inexpensive test for the diagnosis of Parkinson’s is considered essential for the development of neuroprotective therapy, because by the time a patient has the many movement symptoms associated with Parkinson’s, a majority of the dopamine-producing neurons are lost or become impaired by the disease.”

The PDx blood test, which measures changes in particular molecules known to be associated with Parkinson’s, will be available through an Israeli lab on a limited beta basis in early 2017. BioShai will soon apply for regulatory approval in Europe.

BioShai was founded in January 2014 in the Youdim Pharmaceuticals incubator in Yokneam Illit. Among the organization’s cofounders are Dr. Martin Rabey, a professor emeritus at Tel Aviv University’s Sackler School of Medicine who helped develop the Simple Parkinson Evaluation Scale, a practical tool for the evaluation of Parkinson’s patients, and Dr. Moussa Youdim, one of the inventors of the Parkinson’s drug Azilect and a professor at the Technion. Youdim and University of Würzburg Prof. Peter Riederer performed pioneering research, published in 2010 and 2012, revealing that measuring the expression level of specific genes in blood could detect Parkinson’s with a high level of accuracy. BioShai grew out of this discovery.

Yarden told ISRAEL21c that BioShai is currently in the final stages of validating and standardizing the PDx assay in a multi-center clinical trial in Israel and Italy.

“We have enrolled 400 patients, divided into two stages. The first stage is for the creation of a commercial test based on Prof. Youdim’s findings, and the second stage is validation,” she said. “We also are completing a trial on retrospective samples from the Parkinson’s Progression Markers Initiative study led by the Michael J. Fox Foundation. In our lab in Yokneam, we have tested over 1,000 samples including samples from Parkinson’s patients, healthy controls and PD patients who have clinical symptoms but no evidence of dopamine deficit in image scans.”

She noted that the cost of the PDx blood test, estimated to be several hundred dollars, is significantly less expensive than any available imaging test and “will definitely decrease the cost of diagnosis.”

While other companies are working toward a blood test for Parkinson’s, she adds, “Our assay is unique and we hope to be the first in market.”

(via Israel21c)

[Photo: Chris Taylor, CSIRO / WikiCommons ]