Skip to main content
Premium Trial:

Request an Annual Quote

ViaGen, US Food and Drug Administration, and Transgenomic


ViaGen to Use DNA Testing in Angus Beef Verification Agreement

ViaGen, a company specializing in livestock genetics, will begin DNA testing Premium Gold Angus Beef cattle to verify them as registered Angus animals, as part of an agreement announced last week, the companies said in a statement.

The companies will use Austin, Tex.-based ViaGen’s AnguSure DNA verification process and its Inducator test to verify the beef from hair and meat samples provided by Austin-based PGAB. AnguSure “measures the amount of genetic similarity” between the genetics of a sample and the genetics of 152 “top” registered Angus bulls, the companies said. Inducator measures the amount of Brahman genetic content, the companies added.

Financial terms of the agreement were not disclosed.

Pharmacogenomics Data Submission Guidance Due By End of Year, Says FDA’s Lesko

The US Food and Drug Administration will issue the final guidance document for pharmacogenomic data submissions before the end of the year, according to Larry Lesko, director of the FDA’s Office of Clinical Pharmacology and Biopharmaceuticals, in a talk last week at Scientific American’s Targeted Medicine conference.

The document will be “out by January 2005,” Lesko said during a lunchtime keynote address titled “How is the FDA Preparing for the Increasing Application of Pharmacogenomics in Drug Development?”

Organizational difficulties related to the recent presidential election and the requirement that “three people have to sign off” on the guidance in each of the FDA’s related centers contributed to the delay, Lesko said.

The guidance will appear on a special FDA website upon release, along with a companion Manual of Policies and Procedures and “frequently asked questions” documents, said Lesko. He did not disclose the website address.

Following an invited session on pharmacogenetics held Oct. 29 at the 54th annual American Society of Human Genetics meeting in Toronto, Lesko told GenomeWeb News that the guideline’s release was not delayed because of revisions to the document itself. “It’s been done for about four weeks,” said Lesko. “There is no scientific reason it’s not going out.” He said then that the guidance would be issued as soon as final legal and other reviews of the document were completed.

The Jan. 1 due date follows a string of at least three previous, revised deadlines. Pharmacogenomics Reporter reported in July that Lesko expected the completed guidance by the end of the summer. The regulatory agency had originally planned its release by June 30 (see PGx Reporter 7/1/2004).

FDA to Release ‘Theranostics’ Draft Guidance in Early 2005

The US Food and Drug Administration will release a draft of its diagnostic-therapeutic companion product guideline for public comment in February, said Larry Lesko, director of the FDA’s Office of Clinical Pharmacology and Biopharmaceuticals at Scientific American’s Targeted Medicine conference, held in New York last week.

No due date has yet been set for the final companion-product document, which is expected to boost consumption of pharmacogenomic technologies, said Lesko.

The “theranostics” draft guidance was originally slated for release by the end of the year (see PGx Reporter 8/5/2004).

Transgenomic Sells Boulder Facility, Lays off 60 to Trim Costs Amid Mounting Q3 Losses

Transgenomic has sold its oligonucleotide-manufacturing facility and laid off 60 staffers worldwide as the struggling company takes steps to trim expenses and save cash, the company disclosed this week.

Transgenomic announced the belt-tightening moves as part of its third-quarter financial report, in which a mild up-tick in revenue amid widening losses and slightly more than $1 million in the bank painted a bleak near-term picture for the Omaha, Neb.-based company.

Transgenomic said Eyetech Pharmaceuticals paid $3 million for “substantially all” of the assets of its Boulder, Colo.-based synthetic oligo shop. Eyetech also assumed equipment and “other operating leases” associated with the Boulder facility

Eyetech will also retain “essentially all” of the staffers employed at the Boulder facility, Transgenomic said in a statement. The company stressed that the sale will not affect its manufacturing facility in Glasgow, Scotland.

Additionally, Transgenomic will lay off around 60 employees worldwide, and close two US-based research and development facilities linked to the firm’s synthetic nucleic acid business, and two European field offices.

Revenue for the three months ended Sept. 30 inched up to $8.2 million from $7.5 million year over year.

Net losses ballooned to $8.4 million, or $.29 per share, from $6.1 million, or $.25 per share, in the year-ago quarter.

Filed under

The Scan

Pig Organ Transplants Considered

The Wall Street Journal reports that the US Food and Drug Administration may soon allow clinical trials that involve transplanting pig organs into humans.

'Poo-Bank' Proposal

Harvard Medical School researchers suggest people should bank stool samples when they are young to transplant when they later develop age-related diseases.

Spurred to Develop Again

New Scientist reports that researchers may have uncovered why about 60 percent of in vitro fertilization embryos stop developing.

Science Papers Examine Breast Milk Cell Populations, Cerebral Cortex Cellular Diversity, Micronesia Population History

In Science this week: unique cell populations found within breast milk, 100 transcriptionally distinct cell populations uncovered in the cerebral cortex, and more.