FUJIFILM Medical Systems


August 17th, 2020
FUJIFILM Medical Systems U.S.A., Inc. Strengthens Healthcare Portfolio with Addition of In Vitro Diagnostics Solutions. FUJIFILM Wako Diagnostics U.S.A. Corporation will become part of FUJIFILM Medical Systems U.S.A., Inc.

Lexington, Mass., August 17, 2020 – FUJIFILM Medical Systems U.S.A., Inc. announced today that effective October 1, 2020, it will add In Vitro Diagnostics (IVD) to its portfolio of healthcare solutions with the integration of FUJIFILM Wako Diagnostics U.S.A. Corporation, a provider of IVD and life science products. The integration will enhance FUJIFILM Medical Systems U.S.A. Inc.’s portfolio of diagnostic solutions for its healthcare customers through the addition of IVD clinical lab reagents and biomarkers. “With an established portfolio of diagnostic imaging solutions to enable treatment planning, diagnosis and healthcare IT, we look forward to expanding our solutions to include IVD,” said Jun Higuchi, president and chief executive officer, FUJIFILM Medical Systems U.S.A., Inc. “The addition of IVD to our diagnostic portfolio will enable us to provide clinicians with tools to assess risks of disease development through our biomarkers and our existing diagnostic imaging solutions.” FUJIFILM Wako Diagnostics has an established portfolio of biomarkers to assess the risk for the development of hepatocellular carcinoma (HCC) in patients with chronic liver disease. Its IVD portfolio of solutions also includes IVD reagents and systems focused on areas including disorders of lipid metabolism, lupus, rheumatoid arthritis, coronary heart disease, and diabetes. The new IVD group will be led by Hidetoshi (Henry) Izawa, vice president of modality solutions and clinical affairs, FUJIFILM Medical Systems U.S.A., Inc. As part of his current role, Mr. Izawa oversees digital radiography, computed radiography and women’s health groups. Previously, he was responsible for radiology, IVD and endoscopy for FUJIFILM France, and was the Head of Modality for Europe. “This integration will enable us to leverage our expanded resources at FUJIFILM Medical Systems U.S.A., Inc. to offer enhanced clinical support and customer service to IVD customers,” said Henry Izawa, vice president of modality solutions and clinical affairs, FUJIFILM Medical Systems U.S.A., Inc. “We are thrilled to welcome the talented men and women of FUJIFILM Wako Diagnostics U.S.A. Corporation to our group to accelerate new innovations in IVD.” To learn more about Fujifilm’s comprehensive healthcare solutions, visit www.fujifilmhealthcare.com.

For our complete announcement, please click here.

March 1st, 2018
Wako Life Sciences, Inc. announces our company name change on April 1st, 2018.

We are delighted to announce that on April 1st, 2018, Wako Life Sciences, Inc. will change its corporate company name to FUJIFILM Wako Diagnostics U.S.A. Corporation. The domain name of our e-mail address will also change to “@fujifilm.com”. The company will remain operating under its current structure, and continue to promote quality innovative products through our “Wako” brand under the new company name. Should you have any questions, please feel free to contact your customer service representatives at 804-714-1924 or email us at wakodx-customerservice@fujifilm.com. For our complete announcement, please click here.

Oct. 27th, 2017
October is Liver Cancer Awareness Month

Wako Life Sciences, Inc. (Wako) continues to support organizations such as the American Liver Foundation (ALF) by sponsoring and participating in various events aimed to increase the awareness of liver cancer and liver disease. Wako employees also showed their commitment by participating and raising funds for the ALF during the Liver Life Walk San Francisco event on September 18, 2016.

Please visit "Contribution to Community" page

Oct. 27th, 2015
HCC surveillance in an era of biomarkers

Doctor Robert G. Gish, a world renowned hepatologist, speaks about the importance of including biomarkers for HCC risk assessment in liver cancer surveillance programs and proposes his current liver surveillance algorithm as a model. To view the presentation;

Visit "HCC surveillance in an era of biomarkers" page

Please visit "HCC surveillance in an era of biomarkers" page

Dec. 27th, 2014
Mayo Clinic customers can now order both AFP-L3 and DCP using a single Test ID (Order Code).

AFP-L3 and DCP are biomarkers with regulatory clearance for the use in risk assessment of hepatocellular carcinoma (HCC). Research and clinical findings have shown that the use of the two biomarkers in combination can improve the ability to find HCC at an early stage. As such the two biomarkers are regularly ordered together.

Mayo Medical Laboratories created a new Test ID called HCC Risk Panel which consists of the two biomarkers to ease the ordering process. The panel can be ordered using the Test ID, HCCPR.

Other reference laboratories similarly offer the panel as a single test code. Please contact your preferred reference laboratory to obtain their HCC risk assessment panel code. Please note that panel names vary from laboratory to laboratory.

Jan. 27, 2014
Wako Life Sciences, Inc. receives the Northern California Section 2013 AACC Outstanding Contribution to Clinical Chemistry in Science and Technology award for the development of the μTASWako® i30 Immunoanalyzer

Mountain View CA, January 27th, 2013- Dr. Shinji Satomura, President, and Dr. Henry Wada, CSO of Wako Life Sciences, Inc., received an award from the Northern California Section of AACC for the scientific and technology contribution to clinical chemistry achieved by the development of the μTASWako i30 Immunoanalyzer.

PDF Download The Press Release Jan. 27th, 2014

Jul. 29, 2013
Wako Diagnostics granted Medical Device Licences from Health Canada for the μTASWako® i30 Immunoanalyzer, and AFP-L3 and DCP Assays for Liver Cancer Risk Assessment

Mountain View CA, July 29th, 2013-Wako Diagnostics, a division of Wako Life Sciences, Inc., was issued three Class III Medical Device Licences by Health Canada on April 23, 2013 to market the μTASWako i30 instrument with serum biomarkers lectin-reactive alpha-fetoprotein (AFP-L3) and des-gamma-carboxy prothrombin (DCP) tests for clinical use in Canada. The AFP-L3 and DCP tests are intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies and clinical assessment.

PDF Download The Press Release Jul. 29th, 2013

Jul. 26, 2013
Study results support the use of biomarkers AFP-L3 and DCP for risk assessment in Surveillance

Researchers from Thomas Jefferson University Hospital, Philadelphia, PA, presented study results in a poster at the 2013 Digestive Diseases Week (DDW) Conference, supporting the use of serum biomarkers AFP, AFP-L3 and DCP for Risk Assessment in Surveillance of Patients at Risk for HCC development.

PDF Download "DDW 2013 Poster tu1048 Potential usefulness of highly sensitive AFP-L3% and DCP in risk assessment in surveillance of patient at risk for hepatocellular carcinoma (HCC) with total AFP in reference range"

Apr. 1, 2013
Mayo Clinic's Laboratory is now Offering Wako's DCP test

Mayo Clinic, a worldwide leader in Medical Care, is now offering Wako's DCP test (des-gamma-carboxy prothrombin). Wako's DCP test is a serum biomarker test for the risk assessment of patients with chronic liver disease for development of Hepatocellular carcinoma (HCC). The DCP test is now offered at Mayo Medical Laboratories which is a global reference laboratory that operates within Mayo Clinic's Department of Laboratory Medicine and Pathology. The addition of DCP to their test menu will complement their offering of AFP-L3 as the intended use for both tests is HCC risk assessment.

Starting March 2013, this state of the art laboratory facility will perform the DCP test three times per week. The DCP test can be ordered by using Mayo's test code 61844.

For more information, please visit Mayo's Website

March 1, 2011
Announcing 510(k) Clearance of a New Microfluidic-based IVD Test System, the μTASWakoTM i30 Immunoanalyzer, and AFP-L3 and DCP Assays for Liver Cancer Risk Assessment.

PDF Download μTASWAKO i30 Press Release for more detail

Jan. 2009
Wako's DCP test receives a unique CPT code and CMS reimbusement

The Centers for Medicare & Medicaid Services has released the new Clinical Laboratory Fee Schedule test code and final payment for the testing of DCP (Des-gamma-carboxy prothrombin) also known as PIVKA-II. The new code number, unique to DCP, is CPT 83951. This follows the FDA 510(k) clearance of the DCP test in January 2007. Wako's test is the only FDA-cleared DCP assay. Hepatologists and gastroenterologists use DCP as a risk assessment and rule-out test for hepatocellular carcinoma (HCC)

Nov. 2007
DCP test is now available at major reference labs!

DCP complements AFP-L3% measurement for HCC risk assessment. Simultaneous measurement of AFP-L3% and DCP has been demonstrated to increase the sensitivity for HCC detection while maintaining high specificity. DCP test is 510(k) FDA cleared.

Aug. 2007
A new North American multicenter study for clinical utility of AFP-L3% for detection of HCC in patients with chronic hepatitis (CH) C virus-related cirrhosis

PDF Read the full abstract.

June 2007
Mayo Clinic Study evaluates the diagnostic use of the HCC marker, AFP-L3%

PDF Read the full abstract.

Press Release

Feb. 1, 2007
WakoUSA Reports the 510(k) Clearance of Des-Gamma Carboxyprothrombin (DCP) Test for HCC Risk Assessment

PDF Download The Press Release Feb 1st, 2007

Nov. 15, 2006
Wako Diagnostics Reports the Release of a New CPT Code for AFP-L3%

PDF Download The Press Release Nov. 15th, 2007

Other Publications

AFP-L3% on CAP Today

AFP-L3% is highlighted in CAP Today July 06 article, "For tumor markers, hope springs eternal."

PDF Download CAP Today article