Oncotype DX Study Underscores Challenges for Patients, Doctors in Interpreting Genomic Test Results

Around one-third of the women in the study said they comprehended "a moderate amount or less" of the discussion of their Oncotype DX test results with their physician; approximately 25 percent of participants reported that they felt "distressed" when receiving their test results.

AssureRx Updates GeneSightRx Panel with New Gene: CYP1A2

AssureRx has added a fifth gene, CYP1A2, to its GeneSightRx pharmacogenomic test to guide treatment decisions for psychiatric patients.

Abbott, GSK Extend MAGE-A3 Companion Dx Collaboration into Skin Cancer

GSK is conducting a Phase III study for a MAGE-A3-targeting therapeutic for the adjuvant treatment of melanoma. To receive the drug in the study, participants' tumors must be shown to express MAGE-A3 via a molecular test that Abbott is developing.

Myriad Assures Investors of Strong Patent Position Despite ACLU Anti-Gene Patenting Lawsuit

According to CEO Peter Meldrum, Myriad’s strong IP position on the BRACAnalysis test and a large internal database of BRCA mutations ensure that "regardless of the outcome of this particular lawsuit, it will not have a material adverse effect on the company … or on the future revenues of our products."

After GINA, Where Do Life Insurance Firms Stand on Using Genomic Information for Coverage Decisions?

A Maryland-based interest group for life insurers is lobbying the state legislature not to pass laws restricting the use of genetic information — an effort that underscores the prevailing view of payors that genetic data is no different than other clinical factors in making underwriting decisions.

FDA Chief Commits to Completing Rx/Dx Codevelopment Guidance This Year, Improving Regulatory Science

At a luncheon hosted by the Personalized Medicine Coalition last week, FDA Commissioner Margaret Hamburg said the agency will release its drug/diagnostic codevelopment guidance this year, and discussed how personalized medicine can be advanced through a new NIH/FDA partnership.

Pfizer Taps Medco to Educate Physicians in Wake of Unremarkable Sales of PGx-Guided HIV Drug

Although the collaboration is aimed at increasing physician knowledge of genomic testing associated with all HIV drugs, it appears to have stemmed from lower-than-expected sales of Pfizer's CCR5-antagonist Selzentry.

Medco Research Institute to Spearhead PGx Projects; Warfarin Study Results to be Released in March

Pharmacy-benefits manager Medco this week outlined some activities planned for the Medco Research Institute, which is spearheading the company's pharmacogenomics research efforts. Additionally, during the company's 2009 earnings call, officials discussed the acquisition of DNA Direct and the forthcoming release of results from a study looking at PGx-guided warfarin dosing.

Myriad Launches Multi-gene Prostate Cancer Recurrence Test Prolaris

"For the first time, physicians now have a direct molecular measure of a prostate tumor's capacity to divide and grow by examining the mechanics of growth at the molecular level," Myriad said in a statement announcing the launch of Prolaris, a 46-gene prognostic test that quantitatively determines the risk of prostate cancer recurrence in patients who have undergone a prostatectomy.

Pairings

Joel McComb, Ulf Jönsson

Amgen Lays Out Timeline for KRAS Mutation Studies to Dispel Perceptions of Unethical Rx Development

When Vectibix received approval from the US Food and Drug Administration in 2006, "Amgen already knew the response rate was low," according to an Amgen official. The company began collecting patient tissue samples from mid-2005 to early 2007, knowing it would "need those samples for a biomarker analysis."

Roche Charges DxS of Ditching Distribution Agreement in Favor of Parent Qiagen

"DxS is seeking to avoid its exclusive obligation with Roche because it no longer finds it advantageous to benefit from the Roche distribution network," but a termination of the agreement would cause "irreparable" harm, Roche stated in a recently filed complaint.

Timeline for Judge's Ruling in ACLU's Anti-Gene Patenting Case Is Anybody's Guess

Some legal experts believe that US District Court Judge Sweet may wait and see how the Supreme Court handles the method claims in Bilski v. Kappos before ruling on the ACLU case.