Press release

Jun19, 2017
Press officials
RIKEN GENESIS CO., LTD.

Through collaboration with RIKEN GENESIS and Mitsui Information
Start "OncoPrime Basic" Cancer Provide Sequencing Testing
RIKEN GENESIS CO., LTD. (Medical Office: Shinagawa-ku, Tokyo; President and CEO: Nobuhiro Kondo, hereafter "RIKEN GENESIS") announced that it will start provide the cancer clinical genome test OncoPrime Basic based on the contract from Kyoto University Hospital, through a collaboration with Mitsui Information Co., Ltd. (Head Office: Minato-ku, Tokyo; President and CEO: Mitsui Information).

Mitsui Information and Kyoto University Hospital have been study and commercializing personalized medicine, which uses genetic information analysis technology to tailor therapeutic to individual patients, through cancer clinical sequencing tests, representing the first comprehensive cancer genetic analysis "OncoPrime (oncoprim)" to be introduced clinically in Japan.

RIKEN GENESIS is the first company in Japan to acquire CLIA*1 and possesses quality control strengths, enabling reliable inspections in compliance with international quality assurance standards.

In collaboration with multiple study institutions, we have been conducting research aimed at comprehensive genetic analysis of patients' samples (cancer tissue) using the Genetic Diagnosis Panel*2, as treatment plan decisions and drug decisions.

Now, RIKEN Genesis and Mitsui & Co., Ltd. conclude a business alliance agreement to launch OncoPrime Basic, a new contract cancer information sequence testing service.

This service enables faster reporting of test results to patients, since samples are measured and analysis in Japan.

OncoPrime Basic was launched in July as a new line-up of OncoPrime at Kyoto University Hospital, and RIKEN GENESY will serve as the contact point for the service.

In addition to four national university hospitals that have already adopted OncoPrime, a series of 10 institutions with six new facilities will be started.

In this business alliance, RIKEN Genesis and Mitsui Information, together with their next-generation sequencer-based genetic measurement technologies and data analysis technologies, will cooperate to promote new contract cancer clinical sequence testing services that leverage their strengths.

As a Sysmex Group, RIKEN Genesis will contribute to the development and evolution of medical care by providing patients with new cancer diagnostic methods as early as possible in order to realize medical care suitable for each patient.

※1 CLIA(Clinical Laboratory Improvement Amendment; National Laboratory Improvement Act

Clear name
Clinical laboratory quality control for tests.
Certified laboratories shall ensure quality control in inspections if they are required to maintain quality through regular inspections, etc.

※2 Genetic Diagnostics Panel
An assay kit that can simultaneously analyze mutations, amplifications, and fusion of multiple genes of clinical important.

A gene diagnostic panel developed by the National Cancer Research Center is designed to allow appropriate diagnosis of characteristic genetic mutations in Japanese individuals.

Contact Information
Planning Section Dept., Riken Genesis Co., Ltd.
E-mail: info2@rikengenesis.jp
Phone: 03-5759-6042

Riken Genesis Co., Ltd. (Head Office: Shinagawa-ku, Tokyo; President&CEO: Naoto Kondo) will launch the kit in Japan on June 5, 2017, following the insurance application of the OncoGuide®AmoyDx®ROS1 Fusion Gene Detection Kit, an in vitro diagnostic reagent that received marketing approval on January 31, 2017.

This product was approved as a companion diagnostic reagent*1 for in vitro diagnostic reagents that detect ROS1 fusion genes*2 based on the principle of two-step RT-PCR, which is performed sequentially by reverse transcription (Reverse Transcription)*3 and real-time PCR*4. Pfizer Inc. (Head Office: Shibuya-ku, Tokyo; President & CEO: Ichiro Umeda) is an anti-tumor agent/tyrosine kinase inhibitor Xalkoricapsule 200 mg/250 mg (generic name: crizotinib).

On May 18, 2017, Xalkori received additional approval to magnify the indications for non-small cell lung cancer (NSCLC is abbreviated to "NSCLC"), which is unresectable, progressive, or recurrence, ROS1 fusion-positive.

It is estimated that approximately 1% to 2% of patients with NSCLC suffer from ROS1 fusion-positive NSCLC in Japan, and the use of this product is expected to expand the opportunities for therapeutic of patients with NSCLC who achieve ROS1 fusion-positive results.

Pfizer Inc.'s Press Release for Additional Approval

http://www.pfizer.co.jp/pfizer/company/press/2017/2017_05_18.html

Product summary

(1) Product Name: OncoGuide?AmoyDx?ROS1 Fusion Gene Detection Kit (Catalog No. A163)

(2) Nonproprietary ROS1 Fused-Gene Detection Kits

(3) Approval No. 22900 EZX 00002000

(4) Detection of ROS1 fusion gene mRNA in RNA extracted from cancer tissue or cytologic specimens for use (used to aid in determining the indications of crizotinib for non-small-cell lung cancer patients)

(5) Principles of Testing RT-PCR (Reverse Transcription Polymerase Chain Reaction/Reverse Transcription PCR)

(6) FFPE cell blocks from FFPE tissue, fresh frozen tissue, cytologic -derived, or cytologic material in which tumor cells were identified

(7) 2,500 points insured (D004 2 malignancy tissue test)

(8) Packaging 1 kit (24 tests)

(9) Requested sales price of 1 kit: \504,000 (by tax)

(10) Marketing Manufacture Holder, Riken Genesis Co., Ltd.

(11) Manufacturer Amoy Diagnostics Co. LTD (China)

[Comment]

※1 Companion diagnostic (Companion Diagnostics:CoDx or CDx)

Refers to in vitro diagnostic reagents that examine individual genetic information and biomarkers to predict drug effect and dosage before administration.

Use allows for optimal therapeutic and drug selection.

※2 ROS1 fusion genes

The ROS1 gene encodes a receptor tyrosine kinase of the insulin receptor family.

ROS1 fusion genes result from chromosomal rearrangements and have been identified in a variety of human cancers, including lung, bile duct, gastric cancer, and ovarian cancers.

The ROS1 fusion gene in lung cancer results from fusion of the tyrosine kinase portion of the ROS1 gene with a portion of a variety of partner genes, which have been known to be 15 type partner genes.

The resulting kinase protein, produced by the ROS1 fusion gene, is constitutively activity, causing cellular transformation.

※3 Reverse transcription (Reverse Transcription)

A process in which reverse-transcriptase synthesizes a single-stranded complementary DNA (cDNA) template reaction single-stranded RNA as a template.

※4 Real-time PCR

A method for real-time monitoring of PCR amplification products and quantification in exponential amplification regions.

Accurate quantitation based on PCR amplification kinetics is possible.

Inquiries about this case

Planning Section Dept., Riken Genesis Co., Ltd.

E-mail: info2@rikengenesis.jp

Phone: 03-5759-6042