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More articles about Regulatory News & FDA Approvals

The functional genomics firm will offer the DNA Methylation Analysis services from Berlin.

The San Antonio-based firm also intends to file a 510(k) for clearance of the assay.

The firm gained ISO certification for quality management systems.

The designation allows for possible research and development incentives, and qualifies the company for tax credits and a period of market exclusivity following market approval.

The company will offer NimbleGen's gene expression, CGH and CNV, and DNA methylation tools as part of its services in its Beijing lab.

In addition to the NY State permit, Agendia noted that its California lab has been accredited by the College of American Pathologists.

The firm has launched the test through its CLIA lab following completion of validation studies.

Millipore was warned by the agency in September about an e-mail promotion for certain products for H1N1 influenza detection.

The joint venture in the Dallas area will offer clinical lab services, molecular diagnostics, and pharmacogenomic tests and will focus on cancer.

Speaking at the Personalized Medicine World Conference this week, FDA's Elizabeth Mansfield acknowledged that "things are changing hugely" at the agency.

In order to operate in New York, "Navigenics agreed to make certain concessions … by modifying the DTC portion of their business," a regulatory official from the NY Department of Health's Wardsworth Center said this week.

The most widely read articles in Pharmacogenomics Reporter in 2009 included stories on the American Civil Liberties Union's lawsuit against Myriad Genetics and other patent holders of BRCA mutations; the US Food and Drug Administration's labeling updates to the anti-platelet agent Plavix, as well as the colorectal cancer drugs Erbitux and Vectibix; the growth of direct-to-consumer genomics services, such as 23andMe and Navigenics; Myriad's position on genetic counseling; and big pharma's reasons for investing in personalized medicine.

Cepheid became the latest firm to receive an EUA for its H1N1 flu assay, but said it is the first to receive the designation for CLIA moderate complexity labs.

The assay was developed through Affymetrix's MyGeneChip Custom Array Program. It is the latest in a series of molecular diagnostic products to get an FDA EUA.

The certification covers the firm's clinical lab services and research products.

Agendia said that it is the fourth FDA clearance for MammaPrint over the past three years.

The molecular diagnostics company is preparing to commercialize a pancreatic cancer test.

Since the FDA's 2005 preliminary concept paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance. A new white paper from the Personalized Medicine Coalition points out the areas requiring additional regulatory and evidentiary clarity from the agency.

A changing R&D paradigm fueled by the growing demand for personalized medicine is "one of the reasons that the pharmaceutical industry is facing rising taxes," a PricewaterhouseCoopers expert said. As a result, a PwC report released earlier this month advised pharma, biotech, and device firms to invest in tax planning early in their business strategic decisions.

The agency granted Emergency Use Authorization for the GeneSTAT diagnostic test.

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The Washington Post writes that the approval in the US of a SARS-CoV-2 vaccine will be up to Peter Marks, a career official at the Food and Drug Administration.

According to ScienceInsider, the US National Academies of Science, Engineering, and Medicine is planning a study of racism in academic research.

NPR reports the US loan to Eastman Kodak to boost domestic pharmaceutical production is on pause following insider trading allegations.

In Cell this week: blood immune cell changes in COVID-19 patients and spatial transcriptomics in Alzheimer's disease.