Medical and Biological Laboratories Co., Ltd. (MBL) announced that it has launched an in vitro diagnostic kit for the genetic disease Spinal Muscular Atrophy (SMA). The MEBCDX AAV9 test kit, which was licensed from Quest Diagnostics, was approved on April 27 by the Ministry of Health, Labour and Welfare (MHLW) as a companion diagnostic (CDx) kit for the SMA gene therapy ZolgensmaTM (onasemnogene abeparvovec-xioi) launched by Novartis International AG. The test kit will enable laboratory testing through LSI Medience Corporation starting May 8, 2020. SMA is a lower motor neuron disorder characterized by progressive muscle weakness and muscle atrophy resulting from degeneration and loss of anterior horn cells in the spinal cord, often taking away the ability to walk, eat, or breathe. It is the number one genetic cause of death for infants. In Japan, it is reported that there were 858 patients as of 2018, and that approximately 30 patients were children between the ages of 0 to 9 years old. SMA is designated as a rare, but intractable, disease. Zolgensma is a gene therapy product that improves prognosis and motor function by increasing survival motor neuron (SMN) protein expression in motor neurons and then replaces the function of the missing or nonworking SMN1 gene, which is the genetic root cause of SMA. The MHLW approved the therapy on March 19, 2020 with indications: spinal muscular atrophy (including those who do not develop clinical findings but are predicted to develop spinal muscular atrophy by genetic testing), but only patients with anti-AAV9 antibodies negative. The MEBCDX AAV9 test kit was therefore developed as a CDx to be used as an aid in selecting anti-AAV9 antibody negative SMA patients for treatment with Zolgensma. Through mutual agreement, the technology was transferred and a license for commercial manufacturing in Japan was granted to MBL by Quest Diagnostics, who developed this Laboratory Developed Test service for the US market.