We are engaging in efforts such as building a rapid and simple PCR testing system for COVID-19, contributing to molecular epidemiological research, and supporting to  vaccine development as CDMO business. 

PCR testing for new coronaviruses amplifies and detects viral unique genes in samples by PCR. We successfully developed and launched a PCR-based test kit, “SARS-CoV-2 Direct Detection RT-qPCR Kit” in May 2020. This kit does not require RNA extraction and purification from the sample, which previously took about 2 hours, and can be substituted with only 10 minutes of pretreatment. In addition, our unique high-speed PCR reaction allows to obtain results in about an hour. Moreover, it enables simple and rapid PCR testing from saliva samples, too. In November 2020, we also launched “Takara SARS-CoV-2 Direct PCR Detection Kit”, an in-vitro diagnostic reagent approved by the Pharmaceutical Affairs Agency. Takara Bio’s PCR products are used for a broader range of testing needs.

Variants such as Delta and Omicron are known for the new coronavirus. Variants differ in their infectivity, disease severity, and vaccine efficacy, making monitoring of variants an important topic in epidemiological studies.
We are developing and offering products and services that meet its needs, including research reagents for the detection of genetic mutations in variants and contracted service for the whole-genome sequences. Recently, we have been developing the gene detection methods using sewage samples.

As CDMO business, we are collaborating in several vaccine-development projects by leveraging our technologies from clinical development of gene therapy and CDMO business for regenerative medicinal products. 

We are improving a supply chain for stable supply of PCR-related products. 
In a part of the building No. 2 of the Center for Gene and Cell Processing (approx. 2,400 m~{2}) in our head office district, the construction of a series of facilities including fermenters, protein purification equipment and automated packaging system for the new coronavirus PCR test (including in-vitro diagnostic) and important reagents were completed for the production, storage, and shipment. And it started the operation in October 2021. The facility improvement had been adopted by “Project to Promote Domestic Investment for Supply Chain Measures” of the Ministry of Economy, Trade and Industry, and we utilize its subsidy. 

The production capacity after the facility improvement is up to 8 million reactions/month as PCR testing, allowing us to ensure the domestic supply chain of reagents in the situation of pandemic.