• Newsroom
  • Toray Receives Marketing Approval for “Toray APOA2-iTQ” In Vitro Diagnostics Kit for Aid in the Diagnosis of Pancreatic Cancer

Toray Receives Marketing Approval for “Toray APOA2-iTQ” In Vitro Diagnostics Kit for Aid in the Diagnosis of Pancreatic Cancer

Share on facebook Share on twitter Share on Linkedin

Jun. 12, 2023

 Toray Industries, Inc.

Tokyo, Japan, June 12, 2023 – Toray Industries, Inc., announced today that it received marketing approval from Japan’s Ministry of Health, Labour and Welfare on June 8, 2023, for “Toray APOA2-iTQ”. This is an in vitro diagnostic test kit intended for aid in the diagnosis of pancreatic cancer.

It is the first kit approved in Japan to measure two apolipoprotein A2 (APOA2; see note 1) isoform concentrations in plasma. Toray will begin offering Toray APOA2-iTQ domestically once insurance coverage becomes available for it.

APOA2 has a carboxyl (C)-terminal amino acid sequence of alanine (A), threonine (T), and glutamine (Q). In blood, the full-length protein ("APOA2-TQ") and its C-terminal glutamine-degraded isoform ("APOA2-AT") coexist.

Professor Kazufumi Honda of the Graduate School of Medicine of Nippon Medical School discovered that the quantitative ratios of APOA2-AT and APOA2-TQ change in blood of pancreatic cancer patients (see references below). He previously headed the Department of Biomarkers for Early Detection of Cancer at the National Cancer Center of Japan.

Based on the results of joint research with Nippon Medical School and the National Cancer Center, as well as research conducted by AMED (Japan Agency for Medical Research and Development), Toray has obtained unique antibodies that specifically recognize the terminal structures of the two APOA2 isoforms and developed Toray APOA2-iTQ by using the antibodies which can precisely measure the concentrations of these isoforms.

Japan had around 44,000 pancreatic cancer patients in 2019 and about 38,000 deaths from that disease in 2020 (see note 2). Pancreatic cancer is one of cancers which are difficult to detect in early stage because suffers may not notice symptoms until late stage. The survival rate is expected to improve on detection at early stage.

As it is blood-based, Toray APOA2-iTQ enables tests for more people than other approaches. The reagent measures substances different from existing tumor markers and is expected to detect pancreatic cancer which is not detected by those markers.

Contributing to better medical care and hygiene for people worldwide is one of the four priorities of the Toray Group Sustainability Vision. Toray will continue to leverage advanced materials and innovative technologies to develop high-value-added pharmaceuticals in keeping with its corporate philosophy of contributing to society by creating new value while attaining sustainable growth.

Toray APOA2-iTQ Overview
Generic name: Apolipoprotein A2 isoform kit
Purpose: Measure apolipoprotein A2 isoform concentrations in plasma and aid in diagnose pancreatic cancer
Marketing authorization holder: Toray Industries, Inc.

Assay Procedure
Toray APOA2-iTQ is a sandwich enzyme-linked immunosorbent assay kit for measurement of the concentrations of APOA2-AT and APOA2-TQ isoforms, and aids in the diagnosis of pancreatic cancer using APOA2-i Index calculated from APOA2-AT and APOA2-TQ values.

  1. Apolipoprotein A2 is a major component of high-density lipoprotein. It is mainly produced in the liver and small intestine. Large quantities are present in peripheral blood. The mature form of apolipoprotein A2 comprises a 77-amino acid chain, forming a dimer.
  2. Source: Cancer Statistics from Cancer Information Service of National Cancer Center (Vital Statistics of Ministry of Health, Labour and Welfare)

  1. Honda K, Okusaka T, Felix K, Nakamori S, Sata N, Nagai H, et al. Altered plasma apolipoprotein modifications in patients with pancreatic cancer: protein characterization and multi-institutional validation. PLoS One. 2012;7(10):e46908.
  2. Honda K, Kobayashi M, Okusaka T, Rinaudo JA, Huang Y, Marsh T, et al. Plasma biomarker for detection of early stage pancreatic cancer and risk factors for pancreatic malignancy using antibodies for apolipoprotein-AII isoforms. Sci Rep. 2015;5:15921.
  3. Honda K, Srivastava S. Potential usefulness of apolipoprotein A2 isoforms for screening and risk stratification of pancreatic cancer. Biomark Med. 2016;10(11):1197-207.
  4. Honda K. Risk stratification of pancreatic cancer by a blood test for apolipoprotein A2-isoforms. Cancer Biomark. 2022;33(4):503-12.