June 8, 2020
Press Release

Genesis Healthcare Launches Japan’s First COVID-19 Virus RNA Collection Kits Using Deactivation and Stabilization Solution

TOKYO, June 8th, 2020 -- Genesis Healthcare Co., a leading genetic research and testing company, is committed to providing the highest level of SARS-CoV-2 (COVID-19) testing services in Japan, ensuring safety and accuracy that reflects the best interests of the medical community, patients and essential businesses to control the spread of the COVID-19 outbreak.

Three Virus RNA Collection Kits for SARS-CoV-2 (COVID-19) Testing
As a registered Medical Device Manufacturer and Distributor in Japan, Genesis Healthcare has developed three virus RNA collection kits ensuring Medical Practitioners can choose the type of kit best suited for patient symptoms, age and the location of where the test is conducted.

Nasopharyngeal swab-based medical device
Virus RNA Collection Kit leveraging nasopharyngeal swab to collect specimens. Medical device registration in process (registration number 13B3X10143000011).

Oral swab-based medical device:
Virus RNA collection kit leveraging oral swab to collect specimens, registered medical device (registration number 13B3X10143000010).

Saliva-based collection device:

Following the approval by the Ministry of Health, Labour and Welfare to use saliva samples in Polymerase Chain Reaction (PCR) tests, Genesis Healthcare has introduced a virus RNA collection kit to facilitate testing of COVID-19.

Saliva-based collection device is to be used within nine days after developing symptoms of COVID-19, as per guidelines issued by Ministry of Health, Labour and Welfare. A non-medical device to be considered for registration with the PMDA, when a new classification is introduced.

Advanced Safety Procedures for Virus Deactivation and Transportation
As a first in Japan, Genesis Healthcare has introduced additional safety procedures to ensure safe transportation and preservation of the virus RNA specimens from the point of collection to testing laboratory facilities.

Virus deactivation
Going beyond government guidelines and requirements, all virus RNA collection kits from Genesis Healthcare includes an RNA virus deactivation solution, allowing immediate deactivation of the SARS-CoV-2 (COVID-19) virus for safe handling by Medical Practitioners, prevention of contamination during transportation and secure reception in testing laboratories.

This procedure complements the transportation protocols set forth by the Center for Infectious Disease and the separate guidelines set forth by commercial logistics companies, which require 3-layer packaging, that includes two (2) hazard bags.

Stable specimen stabilization
The RNA virus deactivation solution used by Genesis Healthcare preserves and stabilizes the RNA of the specimens at room temperature (24-27ºC) and below to 4ºC. With no need to freeze the solution for transport as is customary with infectious disease testing, specimens are preserved for a period of two weeks to one month for optimum transportation and preservation.
This procedure is currently under patent filing consideration in Japan.

Mandatory Medical Supervision for All Testing
Genesis Healthcare only accepts SARS-CoV-2 (COVID-19) tests originating through medical practitioners and under medical supervision to support the collection of specimens and monitoring of patients in needs of follow up treatment. For essential businesses and corporations with high needs or requirements to test employees for business continuity purposes, collection and test can be supervised by their internally appointed company clinics or doctors or via medical institution in partnership with Genesis Healthcare.

Since the laboratory registration with the Public Health Office as of March 31st, 2020 and commencement of Real-Time RT-PCR tests for SARS-CoV-2 (COVID-19) from April 2nd, 2020, Genesis Healthcare continues to follow the guidelines issued by the Center for Infectious Disease in Japan (refer to the “Genesis Healthcare - Safety, Accuracy and Factsheet”).

With the highest throughput genetic testing laboratory in Japan, Genesis Healthcare has a capacity to conduct 60,000 Real-Time RT PCR tests for SARS-CoV-2 (COVID-19) per month through automated testing procedures, including automated RNA testing equipments and highthroughput PCR machines.

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