Attn: All MediaApril 1, 2020
National Cancer Center
Sysmex Corporation
RIKEN GENESIS Co., Ltd.

Advanced Medical Care Approval for Cancer Gene Panel Testingat the Time of Initial Treatment- Prospective Study to Assess the Feasibility and Clinical Utility of Comprehensive Genomic
Profiling at the Time of Initial Treatment of Patients with Solid Tumors -The “Prospective Study to Assess the Feasibility and Clinical Utility of Comprehensive Genomic
Profiling at the Time of Initial Treatment in Patients with Solid Tumors” (the “Study”), which uses theOncoGuide™ NCC Oncopanel System1 (the “System”, generic name: mutation analysis set forcancer genome profiling) developed through collaboration between the National Cancer Center(Location: Tokyo, Japan; President: Hitoshi Nakagama) and Sysmex Corporation (HQ: Kobe, Japan;
Chairman and CEO: Hisashi Ietsugu), has been applied as Advanced Medical Care2 on April 1, 2020.
The start date of this test will be announced on the website as soon as preparations at the National
Cancer Center are completed. ( https://www.ncc.go.jp/en/ncch/index.html )The System analyzes genetic alterations in cancer-specific genes in patients with solid tumors andprovides the cancer genomic profile of the tumor to help determine the treatment strategy, including
accurate diagnosis and the selection of anti-cancer drugs. Currently, the System is covered by theNational Health Insurance (NHI) in patients who have already undergone the standard treatment.
Personalized genomic medicine based on cancer genomic profiling from an early phase at the timeof initial treatment could provide the patients with more opportunities for appropriate treatment,
including matched therapy. However, the feasibility and clinical utility of the System at the time ofinitial treatment remains unclear.
On April 1, 2020, the “Prospective Study to Assess the Feasibility and Clinical Utility ofComprehensive Genomic Profiling at the Time of Initial Treatment in Patients with Solid Tumors” hasbeen applied as Advanced Medical Care. The National Cancer Center will announce the start dateof this test at the National Cancer Center Hospital on its website as soon as the National Cancer
Center is ready. ( https://www.ncc.go.jp/en/ncch/index.html ).
The Study will include patients with six types of advanced or recurrent solid tumors, which could betreated with medication, including non-small-cell lung cancer, gastric cancer, colon cancer, breastcancer, pancreatic cancer, and biliary tract cancer (a total of 200 cases). We will evaluate whether
personalized genomic medicine based on cancer genome profiling by the System at the time of initial
treatment results in more opportunities of matched therapies compared to after standard treatment.

All collected samples will be analyzed at the Innovation Genome Center (Kawasaki Office) of RIKEN
GENESIS Co., Ltd. (HQ: Tokyo, Japan; President and CEO: Naoto Kondo), a Sysmex subsidiary
which provides lab assay services for gene analysis.
The National Cancer Center, Sysmex and RIKEN GENESIS will contribute to the implementationand development of personalized genomic medicine in Japan by providing high-value testing anddiagnostic technologies for cancer patients.

Product Overview
Generic name:
Gene mutation analysis set (for use in cancer genome profiling)
Name:
OncoGuide™ NCC Oncopanel System(medical equipment production sales authorization number:23000BZX00398000)
Target institutions: Medical institutions that have in place diagnostic systems appropriate forcancer genome profiling
Target market:
JapanReferences
Press release dated December 25, 2018: “Sysmex Receives Manufacturing and Marketing
Approval to Use the OncoGuide™ NCC Oncopanel System in Cancer Genome Profiling”
https://www.sysmex.co.jp/en/news/2018/181225.html
Press release dated May 31, 2019: “The OncoGuide™ NCC Oncopanel System Receives
Insurance Coverage for Use in Cancer Genome Profiling”
https://www.sysmex.co.jp/en/news/2019/190531.html

Terminology
1 OncoGuide™ NCC Oncopanel System:
On December 25, 2018, Sysmex received manufacturing and marketing approval for theSystem as Japan’s first system for cancer genome profiling. This was also the first such
system to be covered under the NHI, as of June 1, 2019.
The NHI coverage for D006-19 cancer genome profiling using the System includes patientswith solid tumors for which no standard treatment exists and patients with solid tumors
confirmed to have advanced locally or metastasized (including patients for which treatment
is expected to conclude). Coverage is limited to cases in which the attending physician
determines the potential for applying chemotherapy following this testing is high based on
chemotherapy guidelines from related societies and the patient’s general status and organfunction. The objective of Advanced Medical Care is to assess utility at the time of initialtreatment.
2Advanced Medical Care:
Refers to advanced healthcare technologies that have been approved by Japan’s Ministerof Health, Labour and Welfare but are not yet covered by healthcare insurance. Based on

a Fundamental Accord in December 2004 between the Minister of Health, Labour andWelfare; the Cabinet Officer Minister of State in Charge of Special Missions (regulatoryreform, industrial revitalization); the minister in charge of administrative reform; and theMinister in charge of Special Zones for Structural Reform and Regional revitalization, thissystem was approved in combination with healthcare insurance coverage from theperspective of ensuring the safety of patients in Japan, preventing patient burdens fromincreasing, expanding patient choices, and increasing convenience.

Media Inquiries:
Office of Public Relations, Strategic Planning Bureau, National Cancer Center Japan
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel: +81-3-3542-2511
Johji Hayashi or Akinobu Seko
IR & Corporate Communication Department, Sysmex Corporation
1-5-1, Wakinohama-Kaigandori, Chuo-ku, Kobe, Hyogo 651-0073, Japan
Tel: +81-78-265-0508
Clinical Sequencing Division, Sales Department, RIKEN GENESIS Co., Ltd.
Art Village Osaki Central Tower 8F, 1-2-2 Osaki, Shinagawa-ku, Tokyo 141-0032, Japan
Tel: +81-3-5759-6042