Doctors diagnose as many as 60,000 new cases of Parkinson’s disease (PD) in the United States every year. Yet diagnosing it 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.
More than 10 million people worldwide are living with this chronic and progressive movement disorder caused by the malfunction and death of neurons that produce dopamine, a chemical that coordinates the brain’s control of movement and coordination.
“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, who holds a doctorate in medical science and formerly was responsible for clinical and commercial development of diagnostic assays and kits at Glycominds. Yarden also is CEO and co-founder of Curewize Health.
“Offering a simple and inexpensive test for the diagnosis of Parkinson’s is considered essential for the development of neuroprotective therapy,” she explained, “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.”
Research in Technion lab
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 apply for regulatory approval in Europe soon.
BioShai was founded in January 2014 in the Youdim Pharmaceuticals incubator in Yokneam Illit in northern Israel. Technion professor Moussa Youdim (one of the inventors of the Parkinson’s drug Azilect) co-founded BioShai, which currently has four employees.
Youdim and University of Würzburg professor 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.
Co-founder Dr. Martin Rabey, a neurologist originally from Argentina, is a professor emeritus at Tel Aviv University’s Sackler School of Medicine and an international expert in Parkinson’s and Alzheimer’s diseases. He and European neurologists developed the Simple Parkinson Evaluation Scale, a practical tool for the evaluation of Parkinson’s patients.
Validating and standardizing
Yarden said that BioShai currently is in the final stages of validating and standardizing the PDx assay in a multicenter 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 professor 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 [Parkinson’s] patients who have clinical symptoms but no evidence of dopamine deficit in image scans.”
This retrospective study will examine how the biomarker changes over time and could help with prognosis as well as diagnosis, Yarden said.
“BioShai’s strategy is to first develop the test for differential diagnosis of [Parkinson’s] from patients with similar Parkinsonian motor features, and then to develop a modified version of the test for earlier diagnosis of patients with pre-motor symptoms, such as decreased ability to smell, constant constipation, depression and REM sleep disorders,” Yarden said. “A lot of these symptoms can appear for other reasons but are also considered non-motor early-risk factors for PD. Our biomarker would be specific for Parkinson’s.”
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.”
She added that while other companies are working toward a blood test for Parkinson’s, “our assay is unique and we hope to be the first in market.”
