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Jun 05, 2013

After Long Silence on LDT Regulation, FDA Commish Revives Thorny Topic at ASCO

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This article has been updated with information about a Citizen Petition filed against FDA regulation of LDTs by the American Clinical Laboratory Association, and with quotes from Sherri Bale. Originally published June 4.

Aug 28, 2012

Meridian Bioscience Provides FY 2013 Guidance

NEW YORK (GenomeWeb News) - Meridian Bioscience today provided financial guidance for fiscal-year 2013 and reaffirmed its 2012 guidance given just a month ago.

May 23, 2012

Thermo Fisher Scientific Eyeing 2016 Revenues of $14.5B to $15.5B

NEW YORK (GenomeWeb News) – Based on expectations of mid-single digit organic revenue growth annually, Thermo Fisher Scientific's revenues for 2016 could fall between $14.5 billion and $15.5 billion, the company said in a presentation at its analyst meeting today.

Feb 01, 2012

FDA Official Says Personalized Medicine Regulation Taking Shape Following Zelboraf, Xalkori Success

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By Turna Ray

Dec 15, 2011

Analysts Lower Complete Genomics' Estimates on Updated Guidance

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Wall Street analysts have revised their revenue estimates for Complete Genomics following a company executive's updated guidance on genome shipments on Wednesday.

Dec 14, 2011

Danaher Forecasts 2012 Revenue Growth of 2 to 5 Percent

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Danaher today reaffirmed its fourth quarter guidance for 2011 and initiated its outlook for 2012.

Sep 07, 2011

At Dx Conference, FDA's Gutierrez Sheds Further Light on Plans for Risk-Based LDT Regulation

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By Molika Ashford

Aug 25, 2011

Meridian Sees 20 to 30 Percent Growth in Fiscal 2012

By a GenomeWeb staff reporter

Jul 27, 2011

Illumina's Shares Fall on Cautious Outlook

The firm's guidance came in below Wall Street expectations, sparking a drop in its shares.

May 19, 2011

Calando Aims to Complete RNAi Phase I Trial, Ink Development Partnership by Year's End

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The CEO of Calando parent firm Arrowhead Research also said that the RNAi shop has restarted preclinical research and development — a notable departure from events in 2009 when the company stopped all such work and shuttered Calando's lab amid a cash crunch.

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The Scan

Commission's First Meeting

At a meeting this week, researchers and others discussed the regulatory oversight needed for germline genome editing.

More Scrutiny

The US Food and Drug Administration has asked questions about Myriad Genetics' GeneSight test, according to Bloomberg.

Web of Neutrophil DNA

Researchers report that neutrophil extracellular traps appear to binds gallstones together, according to New Scientist.

Science Explores Method to Infer Genotype-by-Environment Interactions

In Science this week: approach to infer genotype-by-environment interaction from genetic variants associated with phenotypic variability, and more.

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In Diagnostics

  1. Agilent Q3 Revenues Up 6 Percent

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