Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers April 23, 2017
Pharmacy Choice - Pharmaceutical News - HalioDx performed development work for ipsogen JAK2 510(k) clearance by QIAGEN - April 23, 2017

Pharmacy News Article

 3/30/17 - HalioDx performed development work for ipsogen JAK2 510(k) clearance by QIAGEN

HalioDx performed development work for ipsogen JAK2 510(k) clearance by QIAGEN

  • HalioDx has successfully performed critical development phases for Ipsogen JAK2510(k) in close collaboration with QIAGEN and a panel of international clinical centers
  • QIAGEN has received 510(k) clearance from the U.S. Food and Drug Administration to market ipsogen JAK2 RGQ PCR kit
  • HalioDx intend to further apply its development expertise in immuno-oncology projects


Marseille, France, March 30, 2017 - HalioDx SAS, an immuno-oncology diagnostic company, today announced that its R&D collaboration with QIAGEN N.V., a leading global provider of Sample to Insight solutions, has resulted in a U.S. Food and Drug Administration (FDA) 510(k) clearance for QIAGEN's ipsogen JAK2 RGQ PCR test.

The ipsogen JAK2 RGQ PCR test is a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. It is a real time PCR test performed on the QIAGEN Rotor-Gene Q MDx instrument. The test is intended for use as an adjunct to evaluation of suspected Polycythemia Vera, in conjunction with other clinicopathological factors and will be marketed by QIAGEN as part of their Personalized Healthcare assays portfolio.

HalioDx performed feasibility & development phases including clinical validation on behalf of QIAGEN. Design, verification & validation phases were led by HalioDx on the basis of IDE & pre-IDE approvals. The clinical performance of the ipsogen JAK2 RGQ PCR Kit was evaluated during a multicenter, international, prospective, interventional study conducted by HalioDx. The study had successful patient enrollment at 7 sites in the United States, 12 sites in France, and 5 sites in Italy.

Vincent FERT, CEO of HalioDx comments: "By successfully achieving this project on behalf of QIAGEN we have demonstrated our expertise and capabilities to drive IVD projects through complex US IVD regulatory path. The commitment of our team and the excellent collaboration framework with our partner QIAGEN and international clinical centres exemplify how we want to drive HalioDx company value in the near future. We intend to leverage this expertise with QIAGEN but also with our growing biopharma partners in immuno-oncology".


About HalioDx
The Immune Response to Cancer Diagnostics

HalioDx is an immuno-oncology diagnostic company providing oncologists with first in- class Immune-based diagnostic products and services to guide cancer care and contribute to precision medicine in the era of immuno-oncology and combination therapies.

HalioDx Immunoscore technology integrates immunohistochemistry combined with advanced imaging analysis enabling extraction of spatially-organized tissue molecular information. Immunoscore is a platform for many cancers, as immune response to tumor is a key hallmark of disease progression.

Pioneered by Jrme Galon at the Cordeliers Research Center, Paris, France, Immunoscore Colon is the flagship assay of HalioDx, positioned to be a future diagnostic standard for delivering prognostic and predictive information. HalioDx develops also assays such as Halioseek(TM) and Immunosign to help stratifying patients for immunotherapies.

HalioDx collaborates with an increasing number of renowned international clinical groups and biopharmaceutical companies to support clinical utility and ensure rigorous performance validation of its assays in a large number of cancer indications.

HalioDx has an experienced team of more than 100 employees, a CLIA-certified laboratory (H1 2017) and compliant facilities to develop, manufacture, register and market in vitro diagnostic (IVD) products. HalioDx executes biomarker studies and companion diagnostic assay development in conformity with regulations and in partnership with biopharmaceutical companies. The company co-founded the European immunology cluster Marseille Immunopole (MI).

For more information, please visit our website www.haliodx.com and follow the company on Twitter @HalioDx.

Contacts

HalioDx SAS
Vincent Fert
President and CEO
+ 33 (0)4 91 29 30 90
vincent.fert@haliodx.com

ATCG Press
Marie Puvieux (France)
Mob: +33 (0)6 10 54 36 72
Jean-Mehdi Grangeon (ROW)
Mob: +33 (0)6 62 22 00 24
haliodx@atcg-partners.com

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/f3aa7ad1-03b5-4def-9386-1d306ac3a7ae

Source: HalioDx


2017 GlobeNewswire, Inc.

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

LIVE ONLINE CE

Last Chance
Apr 24: A Look Inside the Top 200 Drugs
Apr 25: Skin Infections: Focus on Cellulitis & MRSA
Apr 26: Medical Marijuana: Examining the Science, Not the Politics
Apr 27: What's New? New Treatments for Type 2 Diabetes
Apr 30: Using Effective Communication to Reduce Medication Errors
Click for entire Webinar Calendar

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...

Nursing Jobs
Are you a nurse looking for a job?

Check out the Nursing Job Source.

Your number one choice for nursing jobs.



Websites » RxCareerCenter.comRxSchool.comClubStaffing.comNursingJobSource.comRN.com
Copyright © 2017 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415