BioShai - PDx Assay

First Blood Test for the Diagnosis of Parkinson’s Disease

Company Profile

BioShai Ltd. is commercializing PDx™, the first blood test for diagnosing Parkinson’s disease (PD). PDx increases diagnostic certainty without waiting for worsening symptoms. BioShai gains value from a management team that has expertise in developing and commercializing diagnostic lab tests. BioShai is proud to have received a grant award from the Michael J. Fox Foundation (MJFF) for Parkinson’s Research for validating the PDx assay on samples from the MJFF-led Parkinson’s Progression Markers Initiative (PPMI) study.

Need

Accurate and early diagnosis of PD is a prerequisite for early intervention by way of treatment, change in life style and patient counselling leading to reduced hospital admissions and symptom severity, delay of disease progression and improvement of patient quality of life.

The diagnosis of Parkinson’s disease is mainly based on clinical criteria relying on the physician’s ability to recognize its characteristic symptoms – there is no definitive lab or imaging test. Thus, clinical assessment by a specialist neurologist is the gold standard of PD diagnosis, with up to 10-30% of patients presenting as PD eventually being reclassified. As a result, many patients are faced with diagnostic uncertainty, waiting from one more than five years before receiving a clear diagnosis.

Product Profile

PDx measures the expression pattern of certain genes altered in blood of a high proportion of PD patients*. BioShai is clinically validating the PDx assay in the clinical trial PDX001 comprising a variety of movement disorder patients plus healthy controls and the PPMI clinical trial including PD patients with longitudinal samples and healthy controls. The validation period will be complete by the end of 2016.  BioShai expects to receive CE for the PDx assay during 2017. Following the PDx assay will transferred to a Beta-site lab and offered to Movement Disorder Clinics in BioShai’s pilot field study.

Product Pipeline

The company’s product pipeline includes a blood test for early detection of PD in patients who have non-motor symptoms, such as depression or REM sleep behavior disorder; a screening test for very early detection of PD in persons above the age of fifty years; and a prognostic test for predicting the rate of PD progression.

Seeking

BioShai is seeking strategic collaboration with pharmaceutical companies and clinical laboratories who are interested in business and research partnership. BioShai is pursuing round A investment for implementation of reimbursement and marketing strategy, initiation of sales, increasing differential diagnostic indications and other pipeline products.

biologo

Investment Profile

  • First blood test for PD
  • Short time to market
  • Highly experienced management team
  • Large product pipeline

Awarded Funding

OCS 2 Year Grant
MJFF Grant

Management Team

  • Dr. Jennifer Yarden, CEO
    Expert in diagnostic assay development. CEO and co-founder of Curewize. Was Director of Clinical Development, Glycominds. PhD Med Science KUL, Belgium.
  • Prof. Martin Rabey, MD, CMO, co-founder
    Co-inventor of PDx. Board certified in neurology with a sub-specialty in PD & Alzheimer’s disease. Former chair of Dept. of Neurology at Assaf HaRofe Medical Center.
  • Dr. Nir Dotan, CTO
    Invented, developed and commercialized diagnostic blood tests for Crohn’s disease and MS. Former CTO of Glycominds. PhD in Biotechnology, TAU, Israel.
  • Dr. Danit Mechlovich, Clinical Project Manager
    Expert in neurodegenerative diseases, focusing on PD. Successfully managing PDx international multi-center clinical trial. PhD in neuropharmacology, Technion, Israel.

Co-founders

  • Prof. Moussa Youdim
    Established Abital Pharma Pipelines to improve PD treatment. Developed Azilect, Teva’s marketed treatment for PD. Was Head of Dept. of Pharmacology at the Faculty of Medicine, Technion for over 30 years.
  • Prof. Peter Riederer
    Neuroscientist co-inventor of PDx. Board Member of Research Committee of the World Federation of Neurology on Parkinsonism and Related Disorders.

Contact