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Snippets: Feb 18, 2009


TrimGen Gets FDA OK for Warfarin Genotyping Test

TrimGen has received US Food and Drug Administration 510(k) clearance for its eQ-PCR Warfarin Genotyping kit, the Sparks, Md.-based firm said this week.

The TrimGen kit tests for SNPs in the VKORC1 and cytochrome P450 CYP2C9 genes, which serve as clinically relevant predictors of warfarin dosing. The assay is used to aid physicians in identifying patients who may be at risk of warfarin sensitivity.

TrimGen is one of several firms over the past year and a half to receive FDA clearance for a warfarin sensitivity test, following Nanosphere, Autogenomics, ParagonDx, and Osmetech.

Guidelines for Genetic-Association Studies Published

The University of Ottawa announced this month that several medical journals are publishing new guidelines for reporting on genetic-association studies.

The initial "Strengthening the Reporting of Genetic Association studies" guidelines were developed during a June 2006 workshop held in Ottawa that involved roughly thirty epidemiologists, geneticists, statisticians, and journal editors.

A report on the workshop was prepared this January and subsequently updated. The guidelines will be further refined based on suggestions from workshop participants and other members of the scientific community. The organizers plan to post the draft guidelines on the Human Genome Epidemiology Network (HuGENet) Canada Coordinating Centre website later this year.

The STREGA statement has been published in several scientific journals, including the Annals of Internal Medicine, the European Journal of Epidemiology, the European Journal of Clinical Investigation, Genetic Epidemiology, Human Genetics, the Journal of Clinical Epidemiology, and PLoS Medicine.

The effort is an extension of the "Strengthening and Reporting of Observational studies in Epidemiology" guidelines and is modeled after the Consolidated Standards of Reporting Trials guidance for reporting clinical trial results.

"This is a large field of research which has created a great deal of debate between those who expect genetic information to transform medicine and health, and those who are skeptical," corresponding author Julian Little, a University of Ottawa researcher who holds the Canada Research Chair in Human Genome Epidemiology, said in a statement. "We hope this initiative will help specialists and non-specialists alike to figure out the factors in methods that help produce solid evidence on which to use genetic information."

Information on the STREGA statement can be found here.

Monogram Biosciences' Q4 Revenues Rise 10 Percent

Monogram Biosciences reported last week that its fourth-quarter revenues increased 10 percent and it swung to a profit from a loss thanks to an adjustment to its convertible debt valuation and interest income.

The South San Francisco, Calif.-based pharmacogenomics test developer had revenues of $15.1 million for the three months ended Dec. 31, compared to revenues of $13.7 million for the fourth quarter of 2007. The results do not include deferred revenue of $2.2 million from sales of its Trofile assay to Pfizer for use with the drug firm's AIDS drug maraviroc (Selzentry).

Monogram posted a profit of $512,000, or $.02 per share, for the quarter, compared to a net loss of $5 million, or $.23 per share, for the fourth quarter of 2007. The results for Q4 2008 include a gain of $3.7 million attributed to a convertible debt valuation adjustment and interest income.

The firm's R&D costs increased around 2 percent to $5.2 million from $5.1 million, while its SG&A spending declined 11 percent to $6.4 million from $7.2 million.

For full-year 2008, Monogram reported revenues of $62.2 million, an increase of 44 percent over revenues of $43.2 million for 2007. The 2008 results do not include deferred revenue of $5.8 million from sales of Trofile to Pfizer.

The firm more than halved its net loss to $11.7 million, or $.52 per share, from $23.5 million, or $1.07 per share. The benefit related to the convertible debt valuation adjustment and interest income for 2008 was $9.8 million compared to $4.7 million for 2007.

Monogram's R&D spending for 2008 was $23.8 million, up 23 percent from $19.4 million in 2007. Its SG&A spending inched up about 2 percent to $32.1 million from $31.6 million.

The company finished the year with $16 million in cash and cash equivalents.

Monogram has established revenue guidance for 2009 of a range between $66 million and $70 million, with deferred revenue from Pfizer expected to be between $4 million and $5 million.

Monogram CFO Alfred Merriweather said in a statement that the firm is taking a number of steps to reduce its use of cash. "These include reduction of costs related to personnel, programs and overhead activities. Additional steps will be taken if necessary to achieve our goal of cash flow breakeven. Together, our cost reductions have taken over $10 million out of our planned 2009 expenses."

He added that Monogram's goal is to reduce its use of cash to roughly $6 million to $8 million for 2009.