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NIST, ERCC, Febit Biotech, BioDiscovery, FDA

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NIST Seeks 'a Few Good Nucleic Acid Sequences' for ERCC

The National Institute of Standards and Technology said this week that it is soliciting "a few good nucleic acid sequences" for possible inclusion in a library of RNA reference materials for use in gene expression research.

NIST said that it is building the library as part of a program with the External RNA Controls Consortium, an ad hoc international consortium of approximately 70 organizations from the public, private, and academic sectors, to develop a set of well-characterized RNA sequences that can be used as a simple but reliable check on the performance of microarrays, QRT-PCR experiments, and other gene expression assays.

According to NIST, which hosts the ERCC, the sequences must be released to the public domain and the sequence library will be used to assemble RNA materials for the planned test suite of external RNA controls. NIST also said that the deadline for inclusion in the first round of testing is April 28.

Another deadline that is rapidly approaching is the ERCC's call for sites that will test the consortium's external RNA controls. According to a January statement from the ERCC, those interested in testing the controls should contact the ERCC by March 30 at http://www.imclgs.org (see BAN 1/31/2006).


Revived Febit Biotech to Employ 50 by Year-End

Febit Biotech, the microarray manufacturer that got a second life last year, said this week that it has been gradually adding employees and expects a headcount of 50 by the end of 2006.

The company said that sales of its Geniom DNA analysis instrument "were on budget already in the year of Febit's re-establishment."

Febit Biotech opened shop in May 2005, 19 months after an earlier incarnation of the firm, also called Febit, went out of business (see BAN 5/25/2005).

The company moved to a new facility in Heidelberg, Germany, and received an undisclosed investment from its original investors, Dietmar and Oliver Hopp.

Febit Biotech re-launched Geniom last summer.


BioDiscovery Opens Sales and Support Center in the Netherlands

BioDiscovery has opened a European sales and support center in the Netherlands, the company said this week.

The microarray bioinformatics firm said it has had a "presence" in Europe for more than eight years. But the company, which is based in El Segundo, Calif., said that "as [its] products have evolved to cover more sophisticated technologies, [it] realized the need for a direct sales and support organization that had a significant understanding of our technology as well as the European market."

The center will be locally managed by TouchDown Biomarketing, which offers sales and marketing and technical and logistical support to life sciences companies to launch their products or services into the European market.


Biomarker Development Tops Priorities for FDA's Critical Path Opportunities

The US Food and Drug Administration last week released a list of high-priority research projects for its Critical Path Initiative and highlighted biomarker development as one of the "most important areas for improving medical product development."

In particular, it empowered a newly formed Predictive Safety Testing Partnership to develop guidelines for biomarker use. The Partnership includes Bristol Myers Squibb, Johnson & Johnson, Merck, Novartis, and Pfizer and will be coordinated by the Critical Path Institute.

The Critical Path Opportunity Report is the first specific blueprint for the agency's Critical Path Initiative, an effort to streamline the drug-approval process by applying new strategies and technologies.

Among the 76 projects outlined, biomarker development and clinical trial reform were areas cited by researchers as most likely to improve the efficiency of product development.

In a statement announcing the priority list, the FDA said it would rely on "partnerships and consortia to accomplish a majority of the projects," as well as "a new, cooperative partnership among the primary ... divisions of HHS."

The agency said it would identify additional specific research projects for the initiative over the next few weeks.

Jim Greenwood, president and CEO of the Biotechnology Industry Organization, said the Report "cited substantial opportunities for better diagnoses, more efficient drug development, and safer and more effective therapies, such as the identification and qualification of new safety and efficacy biomarkers. These advances will play an essential role in helping industry, regulators and other stakeholders deliver on the promise of personalized medicine."

The Scan

Push Toward Approval

The Wall Street Journal reports the US Food and Drug Administration is under pressure to grant full approval to SARS-CoV-2 vaccines.

Deer Exposure

About 40 percent of deer in a handful of US states carry antibodies to SARS-CoV-2, according to Nature News.

Millions But Not Enough

NPR reports the US is set to send 110 million SARS-CoV-2 vaccine doses abroad, but that billions are needed.

PNAS Papers on CRISPR-Edited Cancer Models, Multiple Sclerosis Neuroinflammation, Parasitic Wasps

In PNAS this week: gene-editing approach for developing cancer models, role of extracellular proteins in multiple sclerosis, and more.