Beckman Coulter, Inc. Obtains CLIA Certificate, Licensure for Clinical Sequencing

11-May-2012 - USA

Beckman Coulter, Inc. has obtained a CLIA Certificate of Registration, along with Massachusetts State Licensure, allowing Beckman Coulter Genomics to begin accepting clinical samples for genetic sequencing – the most technically complex CLIA category – and to provide those results to physicians for their use in treating, diagnosing and preventing disease in patients. 

This milestone certification paves the way for detection of BRAF exon 11 (codons 439-477) and exon 15 (codons 581-620) for mutations using PCR-based DNA Sanger sequencing, the first clinical molecular diagnostic assay the company has developed.  Plans call for Beckman Coulter Genomics to develop further CLIA-certified assays using next-generation sequencing for a number of oncology and infectious disease applications.

“This certification allows Beckman Coulter to work more closely with physicians to bring the promise of high-quality molecular diagnostics to benefit greater numbers of patients,” said Joseph Repp, vice president and general manager of Beckman Coulter Genomics. “We’re actively working to bring additional assays to physicians and clinical researchers across the country, as well as help all our customers further their understanding of genetic involvement in disease states.”

<

Other news from the department politics & laws

Most read news

More news from our other portals

Under the magnifying glass: The world of microscopy

Last viewed contents

Early Screening, Innovative Solutions to Underline Importance of ADME/Tox Technologies in Successful Drug Development - Considerable Time, Cost Savings to Accrue from Advanced ADME/Tox Technologies

X-ray pulses uncover free nanoparticles for the first time in 3-D - 'Super microscope' reveals unexpected variety of shapes

X-ray pulses uncover free nanoparticles for the first time in 3-D - 'Super microscope' reveals unexpected variety of shapes

Fluorotechnics appoints European biotech veteran Lars Utterman as non-executive director

Wyatt seeks $25 million in damages from Malvern for willful infringement

VIAFLO Corporation and INTEGRA Biosciences enter into Strategic Partnership

Detect Alzheimer's disease as early as 20 years before the onset? - New blood test shows great promise in the diagnosis of Alzheimer's disease

Detect Alzheimer's disease as early as 20 years before the onset? - New blood test shows great promise in the diagnosis of Alzheimer's disease

Pronota and Molecuence announce collaboration in protein biomarker discovery

Oxford Instruments strengthens links with Taiwan through mutual co-operation and understanding

UMC Utrecht and VectorY Therapeutics collaborate in ALS Biomarker Study - Finding these biomarkers is expected to help diagnose ALS and monitor disease progression and improve the design of future clinical studie

UMC Utrecht and VectorY Therapeutics collaborate in ALS Biomarker Study - Finding these biomarkers is expected to help diagnose ALS and monitor disease progression and improve the design of future clinical studie

SemBioSys Genetics and Syngenta Enter Into Agreement on Protein and Antibody Purification Technology - Deal between biotech companies will strengthen capabilities in biopharmaceuticals

'Twist and shine': Development of a new photoluminescent sensor material

'Twist and shine': Development of a new photoluminescent sensor material

Scientists can track origin of shark fins using 'zip codes' in their DNA - Studies show that coastal sharks have 'DNA zip codes' that can reveal where they were born; underscores potential of DNA testing to monitor fin trade