Otsuka Pharmaceutical has received approval to manufacture and market HemeSight, a gene panel test for haematological malignancies, in Japan.
The company developed HemeSight in collaboration with the National Cancer Center.
The effectiveness of the test was validated by a research consortium that includes Kyushu University, Kyoto University, Nagoya Medical Center and the National Cancer Center.
Otsuka Pharmaceutical now plans to begin the process of qualifying HemeSight for health insurance reimbursement. Marketing of the test will start once launch preparations are complete.
Currently, insurance coverage in Japan includes gene panel tests. But there is no approved test for haematological malignancies until now. Also, Japan’s health insurance reimbursement doesn’t cover cancer genome medicine as of now.
HemeSight is said to be the first gene panel test for haematological malignancies to be designated under Japan’s ‘review system for designated world-first products’ by the Ministry of Health, Labour and Welfare.
It has received approval for manufacturing and marketing in Japan. The product includes the HemeSight In Vitro Diagnostics and the HemeSight Analysis Program.
Recent guidelines from the World Health Organization (WHO) recommend using genomic information for the diagnosis and treatment of haematological malignancies.
The Japanese Society of Hematology has also issued guidelines for genomic testing in this area. It provides recommendations for gene panel testing for each disease and stage.
HemeSight aims to test for genetic abnormalities of haematological malignancies listed in the guidelines.
It will also allow diagnosis, treatment selection, and prognosis prediction based on these abnormalities.
The approval of the test is expected to enhance personalised medicine in haematopoietic oncology in Japan and improve medical care.
Otsuka Pharmaceutical Diagnostics Division general manager Tatsuaki Ohashi said: “With the enactment of the Genomic Medicine Promotion Act, we are very pleased to add HemeSight for haematological malignancies and related diseases to our new product lineup.
“Hematological malignancies are the most common paediatric cancer, and the number of adults with this disease is also increasing. We look forward to contributing to personalised medicine for all patients with haematological malignancies, both adult and paediatric, who need it.”
In February, Otsuka Pharmaceutical and Visterra, an Otsuka group company, secured Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for Sibeprenlimab to treat immunoglobulin nephropathy (IgAN).
