Navigation Links
Saladax Biomedical, Inc. Announces the Formation of a CLIA Laboratory As Part of the Company's Commercialization Strategy
Date:12/6/2012

BETHLEHEM, Pa., Dec. 6, 2012 /PRNewswire/ -- Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic assays to achieve the promise of personalized medicine for new and existing therapeutics, announced today its plans to create a laboratory that meets the Clinical Laboratory Improvement Amendments (CLIA) standards at the company's headquarters in Bethlehem, PA.  Saladax has submitted applications for a CLIA license with both the state of Pennsylvania and the federal government and plans to launch the laboratory in 2013.

The commercialization strategy of Saladax is built upon its proprietary MyCare™ therapeutic dose management assays designed to reduce the toxicity associated with chemotherapy drugs while optimizing treatment efficacy for cancer patients.  The first MyCare assays measure the widely prescribed 5-fluorouracil, paclitaxel and docetaxel and are offered in kit form in markets outside the US.  An additional ten MyCare assays are in development and will be commercialized through the company's CLIA laboratory in the US.

"Expanding our business model to include both the supply of diagnostic reagent kits and the provision of clinical laboratory services gives Saladax the flexibility to successfully address unique market conditions," said Kevin Harter, CEO & President of Saladax.  "Our goal is to improve the safety, quality of life and life expectancy of cancer patients around the world and to do so meeting the ever-growing demand for better care at lower costs."

In conjunction with expanding its presence at Ben Franklin TechVentures in Bethlehem, PA, Saladax announced plans to hire additional professionals as it grows its commercial capabilities. Recently, the company announced the appointment of Mark Myslinski as its new Chief Commercial Officer who will be responsible for the CLIA laboratory and the worldwide commercialization of the MyCare assays.

"Establishing a commercial infrastructure that includes a CLIA-certified laboratory will allow Saladax to penetrate the US market more efficiently and is key to our long-term business strategy," said Mark Myslinski.  "We are excited to bring the full line of our novel diagnostic solutions to cancer patients throughout the world and continue serving our partners as the dose management provider of choice."

About CLIA

In the US, the Centers for Medicare & Medicaid Services (CMS) regulate laboratory testing through the Clinical Laboratory Improvement Amendments (CLIA). The objective of the CLIA program is to ensure quality laboratory testing. A CLIA laboratory is one that operates under CLIA supervision. In total, there are approximately 200,000 CLIA certified laboratory entities in the US.

About Saladax Biomedical, Inc.

Saladax Biomedical develops novel diagnostic assays for the practical delivery of personalized medicine.  Our proprietary line of MyCare™ assays improves the efficacy of existing drugs by optimizing the dose administered for each individual patient.  Saladax's initial focus is oncology, with a portfolio of 13 chemotherapy drug assays in various stages of development.  Three MyCare assays, My5-FU™, MyPaclitaxel™ and MyDocetaxel™, are currently offered to the oncology community in markets around the world. 

The company's MyCare technology platform is broad and flexible, enabling wide application in many therapeutic categories.  This technology also enables Saladax to serve as a valuable partner to pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.

The company was founded in 2004 and is headquartered in Bethlehem, Pennsylvania.  Saladax is ISO 13485:2003 certified.

Saladax Biomedical, Inc.
Adrienne Choma, Esq.
Sr. VP & Chief Operating Officer 
achoma@saladax.com

Media Contact:
Tiberend Strategic Advisors, Inc.
212-827-0020
Andrew Mielach 
amielach@tiberend.com 
or
Claire Sojda 
csojda@tiberend.com


'/>"/>
SOURCE Saladax Biomedical, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Saladax Biomedical, Inc. Issued Six Patents Containing Broad Claims in the Immunoassay Space
2. Saladax Biomedical, Inc. to Present at Biotech Showcase™ 2012
3. CoreLab Partners, Medical Image Assessment Experts, Announces Its Entry Into the Early Alzheimers Imaging Market Space
4. WISE Surgical Solutions LLC Announces Project Hope: Helping People with Debilitating Conditions Including Arthritis, Parkinson's, MS and Spinal Injury Know Their Options
5. Array BioPharma Announces Exercise And Closing Of Underwriters Over-Allotment Option
6. Gallus BioPharmaceuticals Announces Appointment of Senior Baxter Executive as Chief Commercial Officer
7. Topokine Announces Dosing of First Subject in a Phase I Clinical Trial of XAF5 Gel for Local Reduction of Subcutaneous Fat
8. Biocartis Announces Commercial Launch of a New Biomarker Analysis Platform
9. Chemical Publishing Company Announces its Niche Catalog in the Water Technology and Water Treatment Space
10. Japan Bioinformatics Announces Study on Leading Mapping Tools for DNA Mutation Discovery
11. The Scientist Proudly Announces the Top 10 Innovations of 2012
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... 12, 2017 , ... They call it the “hairy ball.” ... depiction of a system of linkages and connections so complex and dense that ... computer science at Worcester Polytechnic Institute (WPI) and director of the university’s bioinformatics ...
(Date:10/12/2017)... ... 12, 2017 , ... BioMedGPS announces expanded coverage of SmartTRAK ... module, US Hemostats & Sealants. , SmartTRAK’s US Market for Hemostats and Sealants ... sealants and biologic sealants used in surgical applications. BioMedGPS estimates the market will ...
(Date:10/11/2017)... ... 11, 2017 , ... The CRISPR-Cas9 system has ... and avoiding the use of exogenous expression plasmids. The simplicity of programming this ... gain-of-function studies. , This complement to loss-of-function studies, such as with RNAi ...
(Date:10/11/2017)... , Oct. 11, 2017  VMS BioMarketing, a leading provider ... nationwide oncology Clinical Nurse Educator (CNE) network, which will launch ... for communication among health care professionals to enhance the patient ... office staff, and other health care professionals to help women ... cancer. ...
Breaking Biology Technology:
(Date:4/5/2017)... 5, 2017  The Allen Institute for Cell Science ... a one-of-a-kind portal and dynamic digital window into the ... the first application of deep learning to create predictive ... lines and a growing suite of powerful tools. The ... and future publicly available resources created and shared by ...
(Date:4/3/2017)... 2017  Data captured by IsoCode, IsoPlexis ... a statistically significant association between the potency ... and objective response of cancer patients post-treatment. ... whether cancer patients will respond to CAR-T ... as to improve both pre-infusion potency testing and ...
(Date:3/29/2017)... the health IT company that operates the largest health ... today announced a Series B investment from BlueCross BlueShield ... investment and acquisition accelerates higi,s strategy to create the ... activities through the collection and workflow integration of ambient ... secures data today on behalf of over 36 million ...
Breaking Biology News(10 mins):