BioShai Ltd. is commercializing PDx-pro™ and PDx™, the first blood tests for the prognosis and diagnosis of Parkinson’s disease (PD). BioShai gains value from proprietary platform technology and management team that has expertise in developing and commercializing prognostic/diagnostic lab tests. BioShai is proud to have received a grant award from the Michael J. Fox Foundation (MJFF) for Parkinson’s Research for studying the PDx marker on the Parkinson’s Progression Markers Initiative (PPMI) study.

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.

PDx measures the expression pattern of certain genes altered in blood of PD patients. Results from the PPMI study demonstrated that the prognostic ability of the PDx-pro genes to differentiate slow from fast PD progression. Patients positive for the assay were over 15 times more likely to have a fast progressing disease. Another clinical trial on a European retrospective cohort is under preparation for validation of the PDx prognostic test. PDx family is comprised of mRNA and microRNA. The assay can differentiate between PD to other movement disorders (Essential Tremor and Atypical PD). Marketing can be initiated after the lab test/s are validated in additional cohorts, expected to be completed by the end of 2021. The PDx assays will be offered to central labs and Movement Disorder Clinics.

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.

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.

www.bioshai.com