News

ResearchDx at Arab Health

Arab Health 3Arab Health is a 4 day event being held from 25th January to the 28th January 2016 at the Dubai International Convention & Exhibition Centre in Dubai, United Arab Emirates. This event showcases product from Medical & Pharmaceutical industry.

“Arab Health has become a key event and international platform in the healthcare industry which, says Simon Page, Managing Director,Informa Life Sciences Exhibitions “showcases the region’s leadership in all aspects of healthcare to a world wide audience.”

One of the largest conferences worldwide, more than 4000 exhibitors will be participating at Arab Health. The related professionals will get to come across, Medical Technology, Laboratory Equipment, Diagnostics, Physiotherapy and Orthopedic technology, Commodities and consumer goods for hospitals, Information and communication technology in healthcare, Surgical Products and services, Facility management, Medical disposables, Healthcare building technology, Medical services, Radiology, Consulting services in healthcare, Cardiology, Medical Publications.

View this mesmerizing video from 2015 for an idea of the caliber of exhibits. https://youtu.be/j9HYpvXMhGw

Visit ResearchDx at booth 7ZG17.

 

ResearchDx Appointment of New Chief Medical Officer to Meet NIH Push for Precision Medicine in Expediting “Bench to Bedside” Strategies for Disease Treatment

Irvine, CA December 7, 2015 – Internationally recognized as the “Contract Diagnostics Organization,” ResearchDx specializes in the development of companion and in vitro diagnostics for the pharmaceutical, biotechnology, research, and diagnostic industries. To meet the demand for leveraging new technology and increase the speed at which new treatments reach patients, life sciences firm ResearchDx has appointed Shelly Gunn MD, PhD, FCAP as Chief Medical Officer and Medical Director of their CAP/CLIA certified clinical laboratory, Pacific Diagnostics.

Dr. Gunn’s addition at ResearchDx and clinical laboratory, Pacific Diagnostics will expand the company’s capabilities in the growing disciplines of Translational and Precision Medicine. Translational medicine aims to expedite the discovery of new diagnostic tools and treatments by using a multi-disciplinary, highly collaborative, “bench-to-bedside” approach. Precision medicine is an emerging approach for disease prevention and treatments individualized to variations in each person’s genes, environment, and lifestyle. https://www.nih.gov/precision-medicine-initiative-cohort-program.

Shelly Gunn Small

The National Institutes of Health (NIH) has made a major push to fund translational and precision medicine, especially within biomedical research, with a focus on cross-functional collaborations (e.g., between researchers and clinicians); leveraging new technology and data analysis tools, and increasing the speed at which new treatments reach patients.

“I am delighted to be joining the globally recognized Contract Diagnostics Organization and look forward to working with the team in Irvine to promote continued excellence in the development of companion diagnostic assays for pharma, biotech, and the medical community. As Chief Medical Officer and Medical Director of our CAP/CLIA accredited laboratory, Pacific Diagnostics, I plan to rapidly translate new and innovative technologies from the research bench into clinically available patient testing for cancer, chronic disease, and wellness,” says Dr. Gunn.

A distinguished expert in molecular pathology, Dr. Gunn specializes in genomic biomarker identification for breast cancer and other solid tumors. Dr. Gunn’s Boards, Licensures, and Certifications include the American Board of Pathology, Certified in Clinical Pathology; Texas, New York, and California licensure, as well as a New York State Certificate of Qualification in Molecular and Cellular Tumor Markers.

For more information on the biopharma companion diagnostic test development process, translational, or precision medicine, please contact media representative Vicki Garcia at 619-660-6730.

 

 

 

 

Case Study – Companion Diagnostic Accelerates Drug to Market

Author: Louis Sintasath, ResearchDx, Director of Business Development

Irvine, CA  – Vemurafenib (Zelboraf) is an oral B-Raf kinase inhibitor originally co-developed by Plexxikon (now part of Daiichi-Sankyo) and Genentech (member of the Roche group or whatever the correct term is) in 2006 for the treatment of late-stage unresectable or metastatic melanoma with the BRAF V600E mutation. It is estimated that 50-60% of melanomas harbor this mutation at amino acid position 600, where valine is replaced by glutamic acid. Vemurafenib is only effective against tumors that harbor the BRAF V600E mutation.

In 2006, Plexxikon entered into a collaboration agreement with Roche Molecular Diagnostics to develop a companion diagnostic test on the Cobas platform to screen for the presence/absence of the BRAF V600E mutation. Initial Phase I studies showed that 80% of patients with a V600E mutation in BRAF showed partial to complete regression.

Phase II (BRIM2) and Phase III (BRIM3) studies were initiated in 2009. Positive results from the phase III trial were reported in 2011, where the response rate was 48.4% among vemuranfenib patients compared to 5.5% of chemotherapy-treated patients. Median progression-free survival for vemuranfenib patients was 5.3 months compared to 1.6 months.

In April 2011, both the companion diagnostic test as well as the drug, branded as Zelboraf, was submitted to the FDA for approval. In August 2011, less than 4 months after submission and just 5 years after the initial IND filing, Vemurafenib received FDA approval for both the drug and its companion diagnostic test.

“Zelboraf provides an excellent example of how a coordinated drug and companion diagnostic development approach can accelerate the FDA approval process,” states Dr. Phil Cotter, Principal and Co-Founder of ResearchDx, and the Laboratory Director of Pacific Diagnostics Clinical Laboratory in Irvine, CA,

Additional information on ResearchDx is available at www.researchdx.com. For more information on the Contract Diagnostic Organization process, please contact ResearchDx.
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Irvine’s ResearchDx Signs Agreement with Micron, Inc. of Tokyo

Irvine, CA February 14, 2015 – ResearchDx, Inc. of Irvine, California and Micron Inc. of Tokyo, Japan have entered into an agreement for international collaborative clinical trials. The in vitro diagnostic development processes, laboratory and clinical services of ResearchDx will partner well with Micron’s imaging technologies.
Micron logo
Through the collaboration, companies in the U.S., Canada, the European Union, Central and Eastern Europe looking to conduct trials in Japan and the Asia Pacific region will be directed to Micron’s medical imaging solutions. Alternately, pharmaceutical and medical device companies from Japan, the Asia Pacific and Oceania regions will be sent to the clinical and laboratory services available through ResearchDx.

Micron has established an environment to implement many multicenter imaging clinical trials, especially in Asian countries, including Japan and Korea. Through the comprehensive collaboration with ResearchDx, Micron will be able to broaden services beyond Asia to handle multinational, multicenter clinical trials and expand analysis services in clinical laboratory and diagnostics to the U.S. and other countries.

As an imaging core lab, Micron’s performance has been acknowledged by many pharmaceutical companies in a wide array of imaging clinical trials with global standards of quality. Micron’s strengths are based on accumulated know-how in the fields of standardization of image acquisition techniques, ensured high quality image collection for reliable image reading, and smooth imaging clinical trial operations.

For more information on Micron visit http://www.micron-kobe.com/english/company/greeting.php#

ResearchDx, Leading Personalized Medicine and Contract Diagnostics Organization to Attend San Francisco Conference

International Molecular Medicine Tri-Conference Welcomes Noted
Irvine Companion Diagnostics Company

Irvine, CA February 3, 2015 – ResearchDx, Inc. of Irvine, California will exhibit at the 22nd International Molecular Medicine Tri-Conference in San Francisco, CA at Moscone North Convention Center on February 15-20, 2015. Over 3000 attendees from over 40 countries will attend and take part in the 400+ presentations and panel discussions.

The 6-day event on molecular medicine will focus on drug discovery, genomics, diagnostics and information technology. Attendees gain insight and knowledge that can impact their research and drive change in working towards shaping the future of medicine

“Personalized medicine is increasing in importance and a critical adjunct is the availability of suitable companion diagnostic assays used to stratify patients for eligibility for a particular drug, monitor disease status or used to determine drug dosage,” said Dr. Philip Cotter, Principal and Co-Founder of ResearchDx. “Regulatory agencies have indicated the desirability of co-developing pharmaceuticals and associated companion diagnostic assays. We provide a flexible, integrated service to pharmaceutical companies wanting to outsource companion diagnostic assay development. We offer consulting, assay development, assay kit manufacture, clinical trial management and regulatory services and a Clinical Laboratory. The combination of these services allows outsourcing of the complete companion diagnostic development process to a single business partner, ResearchDx.”

The direction for ResearchDX at the conference will be on providing services for the growing clinical laboratory and diagnostics markets. A Contract Diagnostics Organization (CDO), ResearchDX was formed in 2008. The Consulting Services Division of ResearchDx provides comprehensive Clinical Laboratory consulting services encompassing quality management systems; assay design, validation and implementation; and consulting for CLIA and International CLIA certification, State licensures, and Joint Commission International, College of American Pathologists, and ISO 15189 accreditations.

“As the leading Contract Diagnostics Organization, ResearchDx can provide strategic partnerships to biopharmaceutical and diagnostic companies looking to develop companion diagnostics or in vitro diagnostic products for the local, US or European markets. We provide a full range of companion diagnostics and in vitro diagnostics services,” said Dr. Mathew Moore, Principal and Co-Founder of ResearchDx.

ResearchDx is the leading Contract Diagnostics Organization serving the biopharmaceutical and diagnostic industries. The company provides comprehensive, integrated, and flexible services for the in vitro diagnostic development process. From initial assay conceptualization, discovery, optimization, and validation in a CAP/CLIA laboratory environment through a complete set of clinical research services and regulatory approval, ResearchDx offers solutions to meet customers’ complex needs in diagnostics development. ResearchDx’s primary service areas include assay research and development, clinical laboratory services, clinical research, diagnostic manufacturing, and consulting. Additional information is available at www.researchdx.com.

ResearchDx, the Leading Contract Diagnostics Organization Reaches the Mid-East at The Arab Health 2015 Show in Dubai

Irvine Company Grows Clinical Laboratory Consulting Services Internationally

Irvine, CA January 20, 2015 – ResearchDx, Inc of Irvine, California will exhibit at The Arab Health 2015 Show, January 26th-29th at the Dubai International Convention & Exhibition Centre, Dubai, UAE. Over 60 other countries will be represented; sponsors include Medtronic and GE. International medical and health firms will showcase their products and services, including Johns Hopkins Medicine International, University of Chicago Medicine, Boston Children’s Hospital, The Mayo Clinic and the College of American Pathologists. The exhibition is expected to host over 125,000 attendees.

The focus for ResearchDX will be on the growing Middle East clinical laboratory and diagnostics markets. The company provides services from assay conceptualization, discovery, optimization and validation to regulatory approvals.

“ResearchDx is increasingly working with international clients seeking accreditations for their Clinical Laboratories. ResearchDx offers its clients unparalleled experience in opening, licensing, and operating Clinical Laboratories, both in the U.S. and overseas,” said Dr. Philip Cotter, Principal and Co-Founder of ResearchDx. “Internationally recognized clinical laboratory accreditations provide a competitive edge. These accreditations and licensures have enabled clients to compete for multi-national based clinical trial studies and demonstrate the internationally recognized quality of their laboratories.”

A Contract Diagnostics Organization (CDO), ResearchDX was formed in 2008 and is based in Irvine, California. The Consulting Services Division of ResearchDx provides comprehensive Clinical Laboratory consulting services encompassing quality management systems; assay design, validation and implementation; and consulting for CLIA and International CLIA certification, State licensures, and Joint Commission International, College of American Pathologists, and ISO 15189 accreditations.

“As the leading Contract Diagnostics Organization, ResearchDx can provide strategic partnerships to Middle Eastern biopharmaceutical and diagnostic companies looking to develop companion diagnostics or in vitro diagnostic products for the local, US or European markets. We provide a full range of companion diagnostics and in vitro diagnostics services,” said Dr. Mathew Moore, Principal and Co-Founder of ResearchDx.

ResearchDx is the leading Contract Diagnostics Organization serving the biopharmaceutical and diagnostic industries. The company provides comprehensive, integrated, and flexible services for the in vitro diagnostic development process. From initial assay conceptualization, discovery, optimization, and validation in a CAP/CLIA laboratory environment through a complete set of clinical research services and regulatory approval, ResearchDx offers solutions to meet customers’ complex needs in diagnostics development. ResearchDx’s primary service areas include assay research and development, clinical laboratory services, clinical research, diagnostic manufacturing, and consulting. Additional information is available at www.researchdx.com.

AMP Celebrates 20 Years! The AMP 2014 Annual Meeting and 20th Anniversary Celebration will be held November 12-15, 2014 at the Gaylord National Resort & Convention Center National Harbor, MD (just outside of Washington, DC). Corporate Workshop Day will also be held there on Wednesday, November 12.

The AMP scientific meeting is held annually in the Fall. The 4-day event includes a keynote lecture by the distinguished recipient of the AMP Award for Excellence in Molecular Diagnostics. The program also includes poster sessions and invited speakers for workshop and plenary sessions in each of the four major areas of clinical molecular diagnostics including: hematopathology, infectious disease, inherited genetic diseases, and solid tumors.

The meeting also includes several technical workshops and is preceded by one day of corporate sponsored technical workshops. Attendees present their scientific data during poster sessions. Further exchange of ideas and the establishment of collaborative projects is facilitated by working lunch meetings, corporate exhibits and casual social gatherings.

ResearchDx will be there.  Visit our booth and say hello!

Upcoming Meetings

BioPharma Asia
biopharmasia-convention
March, 2015
International Convention & Exhibition Centre
Suntec Singapore
www.terrapinn.com/exhibition/bio-asia/


Clinical Laboratory Management Association
CLMA
March 29 – April 1, 2015
Orlando, FL
http://www.clma.org/


American Association for Cancer Research
aacr_2015
April 18-22, 2015
Pennsylvania Convention Center
Philadelphia, Pa.
http://www.aacr.org/


Association for Molecular Pathology
AMP logo
November 5-7, 2015
Austin Convention Center
Austin, TX
www.amp.org


Past Meetings

Molecular Med Tri-Conference 2015
Molecular Med Tri-Con 2015
Feburary 15 – 20, 2015
Moscone North Convention Center
San Francisco, California
www.triconference.com


Arab Health 2015
Arab Health 2015
26 – 29 January 2015
Dubai International Convention & Exhibition Centre
Dubai, United Arab Emerites
http://www.arabhealthonline.com/en/welcome/


Association for Molecular Pathology
Association-for-Molecular-Pathology-meeting-2014
November 12-15, 2014
Gaylord National Resort & Convention Center
National Harbor, MD
www.amp.org


The 3rd World Congress on Controversies in Hematology
The 3rd World Congress on Controversies in Hematology
September 11 – 13, 2014
Istanbul, Turkey
www.comtecmed.com


Galaxy Community Conference
galaxy-community-conference-2014-logo
June 30 – July 2, 2014
Homewood Campus
Baltimore, MD
www.galaxyproject.org


DIA 2014
dia
June 15 – 19, 2014
San Diego Convention Center
San Diego, CA
www.diahome.org


BioPharma Asia
biopharmasia-2014
March 10 – 13, 2014
Suntec Convention & Exhibition Centre
Singapore
www.terrapinn.com/exhibition/bio-asia/


Molecular Med Tri-Conference 2014
mmtc-logo-2014
Feburary 9 – 14, 2014
Moscone North Convention Center
San Francisco, California
www.triconference.com


Arab Health 2014

27 – 30 January 2014
Dubai International Convention & Exhibition Centre
Dubai, United Arab Emerites
http://www.arabhealthonline.com/en/welcome/


Biopharma India

November 25 -26, 2013
Hyatt Regency
Mumbai, India
http://www.terrapinn.com/conference/biopharma-india/index.stm


Association for Molecular Pathology

November 14 -16, 2013
Phoenix Convention Center
Phoenix, Arizona
http://www.2013amp.org/index.cfm


Next-Generation Dx Summit
nextgen_logo
August 20–22, 2013
Washington, DC
www.nextgenerationdx.com


Partnerships in Clinical Trials 2013

April 21-24, 2013
Orlando World Center Marriott


bio_pharma_logo
BioPharma Asia
March 18 -21 at Resorts World Sentosa, Singapore
www.terrapinn.com/exhibition


Molecular Med Tri-Conference 2012
logo_tricon
February 11–15, 2013
www.triconference.com


Sponsoring and speaking at World CDx:
logo_worldCDx
November 12–15, 2012
Revere Hotel
Boston
www.world-cdx.com


Next-Generation Dx Summit
nextgen_logo
August 21–23, 2012
Washington, DC
www.nextgenerationdx.com


Partnerships in Clinical Trials 2012
logo_part
March 5–7, 2012
The Marriot World Center
Orlando, FL
www.iirusa.com


Molecular Med Tri-Conference 2012
logo_tricon
February 19–23, 2012
www.triconference.com


4th International Conference on Drug Discovery and Therapy
logo_icddt
February 12–15, 2012
Dubai, UAE
www.icddt.com

ResearchDx in the News

Jan 26 -29 ResearchDx, Inc of Irvine, California will exhibit at The Arab Health 2015 Show, January 26th-29th at the Dubai International Convention & Exhibition Centre, Dubai, UAE. Over 60 other countries will be represented; sponsors include Medtronic and GE. International medical and health firms will showcase their products and services, including Johns Hopkins Medicine International, University of Chicago Medicine, Boston Children’s Hospital, The Mayo Clinic and the College of American Pathologists. The exhibition is expected to host over 125,000 attendees.
September 4, 2014, Mirati Therapeutics Using NGS to Identify Best Responders to Multiple Oncology Drugs.Mirati Therapeutics is studying a number of personalized medicine cancer drugs, for which it is planning to use next-generation sequencing platforms to interrogate complex genetic markers associated with patient response.
April 22, 2014, ResearchDx receives a Strategic Partner Award from WuXi AppTec for providing outstanding consulting and personnel services. With our consultation, the WuXi AppTec Genome Center Clinical Laboratory became the first and only CLIA-certified clinical laboratory in China.
March 11, 2014, ResearchDx proudly sponsors the Asia Biopharma Convention 2014. In addition to companion diagnostic development, we offer comprehensive assistance for US CLIA certification. Find us at the next meet up to learn more.
January 27, 2014, ResearchDx expands its operations to the Middle East. Join us at the 2014 Arab Health Congress in Dubai, UAE to find out how the leading Contract Diagnostics Organization (CDO) provides strategic partnerships for companion diagnostics and in vitro diagnotics development.
November 24, 2013, ResearchDx has its sights on India with the upcoming BioPharma India Convention. Both Co-Founders and Principals discuss what the company can offer to the Indian biopharmaceutical and diagnostics markets. View the Press Release
October 7, 2013, ResearchDx featured in Irvine Scientific case study on providing quality diagnostic services with Chang Marrow culture medium.
February 11, 2013, Frost & Sullivan Recognizes ResearchDx for Its Impressive Performance in the Companion Diagnostics Sector View the Press Release
July 23 2012, An interview with ResearchDx in Pharmaceutical Outsourcing www.pharmoutsourcing.com
June 2012, ResearchDx executives featured in June issue of Drug Development and Delivery
February 2012,ResearchDx principal interviewed in The Bentham Science Newsletter
January 2012, ResearchDx article on Advancing Personalized Medicine featured in the January Issue of Drug Development and Delivery
November 2011, Contract Diagnostics Organization featured in Pharmaceutical Executive Magazine, ‘Inside Outsourcing
June 17, 2011, ResearchDx announces Partnership with bioinformatics company CompanDX
May 2011, ResearchDx featured in ‘PharmaVoice’ magazine
Feb 23-25, 2011, ResearchDx showcased at the New Products Pavillion at the Molecular Medicine TRI-CON 2011 Conference
Feb 22, 2011, ResearchDx Announces the First Contract Diagnostics Organization (CDO)