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Roche Diagnostics, FDA, DeCode Genetics

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Future of Roche Dx’s Five Remaining ASRs Unclear

Roche Diagnostics’ forced decision two weeks ago not to sell its AmpliChip CYP450 microarray as an analyte-specific reagent leaves in limbo the fate of five additional chips the Swiss company is to co-develop with Affymetrix.

In May, a Roche official said the company will introduce six new diagnostic products over the ensuing 18 months — nine months as of this week — based on Affy’s GeneChip platform, which it licensed in January. The AmpliChip, launched in June following a brief delay, was the first of the six.

Roche now is set to commercialize five additional diagnostics — for human papilloma virus, cystic fibrosis, colorectal cancer, HIV, and leukemia. But these plans may have been stifled since a US Food and Drug Administration letter told the company its AmpliChip could not be sold as an ASR in the United States [see 11/6/03 SNPtech Reporter].

Roche’s original plan was initially to sell the AmpliChip as an ASR, and in 2004 to launch the product as an in vitro diagnostic once the FDA has approved the product for that purpose. A Roche spokeswoman recently said the company still expects to seek regulatory approval of the AmpliChip as an IVD in 2004, and will sell the AmpliChip in the interim to drug makers for pre-clinical research.

The spokeswoman did not return a phone call seeking comment on the status of the five remaining ASRs.


FDA Will Begin Enrolling Members to Genetic Data Group in December …

The US Food and Drug Administration plans in mid-December to begin recruiting members for a novel inter-agency group responsible for cataloging genetic data voluntarily submitted by drug makers, according to an FDA official.

Lawrence Lesko, director of clinical pharmacology and biopharmaceutics at the Center for Drug Evaluation and Research, said the size of the Interdisciplinary Pharmacogenomic Review Group, or IPRG, will depend on the volume of data it receives. Lesko made his comments last week at the Pharmacogenomics in Drug Development and Regulatory Decision-Making meeting in Washington, DC.

According to the FDA’s recently released draft guidance on the use of pharmacogenomics data, the IPRG will collect and “review” voluntary genetic data submissions “to work on ongoing policy development, and to advise review divisions dealing with pharmacogenomic data.” [see 11/6/03 SNPtech Reporter]

In a statement released hours after the FDA issued its draft, the Biotechnology Industry Organization called this portion of the draft guidance a “mechanism for comfortably sharing exploratory pharmacogenomic information with the FDA — without stalling ongoing drug development.”

The biotechnology industry “supports the concept of such voluntary genomic data submissions,” the group wrote.


... and Will Synchronize PGx Definitions With European Regulators in June 2004

The US Food and Drug Administration will meet with its European counterpart this summer in an attempt to synchronize their definitions of pharmacogenomic data, an FDA official said.

Lawrence Lesko, director of clinical pharmacology and biopharmaceutics at the Center for Drug Evaluation and Research, said members from his group and the European Agency for the Evaluation of Medical Products, known as EMEA, will meet during an International Conference on Harmonization in June 2004.

Lesko stressed that the meeting is informal, and will occur only because principals from both agencies will be attending the broader ICH meeting.


DeCode Acquires Rights to Bayer Heart Attack Candidate

DeCode Genetics has acquired from Bayer exclusive worldwide rights to a small-molecule compound active against a target made by a gzene linked to myocardial infarction.

Terms of the deal call for Bayer to receive clinical-development milestones, as well as royalties on future sales of the drug.

DeCode said that it plans to begin testing the compound, called DG031, for efficacy in a Phase II trial beginning in early 2004. Additional information about the investigational drug will be made available in a paper that will be submitted for publication at the start of the study.

“By licensing an existing compound already found to be well-tolerated, designed against one of our key targets in myocardial infarction, we will be able to leapfrog several stages in the drug development process,” DeCode CEO Kari Stefansson said in a statement.

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