Navigation Links
Announcing 510(k) Clearance of a New Microfluidic-based IVD Test System, the uTASWako® i30 Immunoanalyzer, and AFP-L3 and DCP Assays for Liver Cancer Risk Assessment.

RICHMOND, Va., March 1, 2011 /PRNewswire/ -- Wako Diagnostics, a division of Wako Chemicals USA, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the uTASWako i30 instrument with alpha-fetoprotein L3 (AFP-L3) and des-gamma-carboxy prothrombin (DCP) in vitro diagnostic (IVD) tests in the USA.  The AFP-L3 and DCP assays are intended for use by healthcare professionals as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC).



"Wako is very pleased to receive 510(k) clearance for these assays using microfluidic technology," said Peter Panfili Ph.D., General Manager, Wako Diagnostics. "We expect that the adoption of these biomarkers into HCC surveillance programs will complement the use of imaging technologies to bring about the desired earlier detection and treatment of liver cancer."

HCC, primary liver cancer, is currently the fastest growing cause of cancer-related death in the USA. It has been demonstrated that HCC surveillance programs for at-risk patients improves applicability of curative therapies. Incorporating these biomarkers as additional surveillance tools will improve the chance of detecting early stage HCC and improve patient outcomes.

Microfluidics has enabled miniaturization and integration of key analyzer processes for the uTASWako i30: sampling, mixing, separation, and detection on microfluidic chips.  The system uses immunochemical and electrophoretic techniques to achieve rapid, accurate, precise and sensitive assay results.

As a bench top automated instrument, the uTASWako i30 is designed for efficiency and ease of use in a clinical chemistry setting.  Up to six analytes may be selected per patient sample with the first result reported in nine minutes. With automated calibration and quality control, the uTASWako i30 requires minimal setup time.  Reagent usage is tracked using radio frequency identification (RFID) tags.

The uTASWako i30 reports AFP-L3%, total AFP, and DCP values using Wako's unique reagents. This IVD test system is available to hospital laboratories, reference laboratories and tertiary care centers.  Wako is the only company that offers 510(k)-cleared AFP-L3 and DCP assays for IVD use.

About Wako Diagnostics

Wako Diagnostics, a division of Wako Chemicals USA, headquartered in Richmond, VA, is a solely owned subsidiary of Wako Pure Chemicals, with headquarters in Osaka, Japan. Wako Pure Chemicals offers a comprehensive range of reagents for both clinical and research laboratories, as well as specialty chemicals.  More information may be obtained at

SOURCE Wako Diagnostics
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Announcing Companies to Present at the 7th Annual MidAmerica Healthcare Venture Forum
2. Announcing the Inaugural ACS Careers Virtual Career Fair in Conjunction with Informex and C&EN
3. BD Announces FDA 510(K) Submission of Rapid Molecular Test to Identify Patients Carrying Staph Superbug Prior to Surgery
4. Two Point of Care Tests From Quest Diagnostics Receive FDA 510(k) Clearance
5. BD Announces FDA 510(k) Clearance of Two-Hour Test to Identify Superbug in Patients with Positive Blood Cultures
6. Kingfisher Announces FDA 510(k) Clearance of Breakthrough KFH Energy for Chronic Pain Sufferers
7. Cardica Reports Positive Top-Line Results and Submits 510(k) for PAS-Port(R) Proximal Anastomosis System in Cardiac Bypass Surgery
8. AdvanDx Submits Yeast Traffic Light PNA FISH(TM) for FDA 510(k) Clearance for Detection of Candida species in Positive Blood Cultures
9. Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test
10. PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in Expanded Indications
11. Life Spine(R) Announces 510(k) Approval of SENTINEL(TM) OCT System
Post Your Comments:
(Date:6/24/2016)... Mass. , June 24, 2016   ... Spaulding Rehabilitation Network,s Dean Center for Tick ... Physical Medicine and Rehabilitation, MIT Hacking Medicine, University ... for Innovation, today announced the five finalists of ... for Lyme disease.  More than 100 scientists, clinicians, ...
(Date:6/24/2016)... , June 24, 2016 The Academy of ... recommendations that would allow biopharmaceutical companies to ... entities that make formulary and coverage decisions, a move ... of new medicines. The recommendations address restrictions ... appear on the drug label, a prohibition that hinders ...
(Date:6/24/2016)... Research and Markets has announced the addition of ... report to their offering. ... The World Market for Companion Diagnostics covers the world market ... the report includes the following: , World ... Region (N. America, EU, ROW), 2015-2020 , World IVD ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the ... In terms of the latter, setting the bar too high can result in disappointment, ... just slow progress toward their goal. , Research from reveals ...
(Date:6/24/2016)... Michigan (PRWEB) , ... June 24, 2016 , ... June ... about the dangers associated with chronic pain and the benefits of holistic treatments, ... individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Global law ... magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition are ... , Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain ... for a minimum wage raise to $12 an hour by 2020 and then adjusting it ... the lost value of the minimum wage, assure the wage floor does not erode again, ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... Living, is proud to recognize Dr. Barry M. Weintraub as a prominent plastic ... most beautiful women in the world, and the most handsome men, look naturally ...
Breaking Medicine News(10 mins):