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Toray Files Manufacturing and Marketing Approval for In Vitro Diagnostic Test of Changing Apolipoprotein A2 Isoform Concentrations in Blood of Pancreatic Cancer Patients

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Sep. 14, 2022

Toray Industries, Inc.



Tokyo, Japan, September 14, 2022 – Toray Industries, Inc., has announced today that on June 27 of this year, it filed a manufacturing and marketing approval with the Ministry of Health, Labour and Welfare for an in vitro diagnostic test to measure apolipoprotein A2 (APOA2) isoform concentrations in blood.

APOA2 is a major component of high-density lipoprotein (HDL), and comprises a 77-amino acid chain. There is a carboxyl (C)-terminal amino acid sequence of alanine (A), threonine (T), and glutamine (Q). The APOA2-ATQ full-length protein and APOA2-AT C-terminal degraded isoform coexist in blood.

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

Toray has furthered on his research in developing a reagent to measure APOA2 isoform as an in vitro diagnostic test. The company is collaborating with the Nippon Medical School, leveraging research findings from the National Cancer Center and Japan Agency for Medical Research and Development.

This reagent measures both APOA2-AT and APOA2-ATQ levels in the blood of individuals with suspected pancreatic cancer. The reagent uses a proprietary Toray antibody in a sandwich enzyme-linked immunosorbent assay.

The key goals of Toray Group Sustainability Vision are to help enhance medical care and public health. 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 values while attaining sustainable growth.


References
  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.