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Snippets: Dec 31, 2008

Genomic Health Presents New Studies for Oncotype DX at San Antonio Breast Cancer Symposium
At the San Antonio Breast Cancer Symposium earlier this month, Genomic Health reported findings from a European study demonstrating that the Oncotype DX Recurrence Score result is an independent predictor of distant recurrence in both node-negative and node-positive hormone receptor-positive breast cancer patients who are treated with the aromatase inhibitor anastrozole or with tamoxifen.
Oncotype DX is a multi-gene expression test that predicts the likelihood of chemotherapy benefit and breast cancer recurrence. The test is currently marketed to women with early-stage (Stage I or II), node-negative, estrogen receptor-positive invasive breast cancer who will be treated with hormone therapy.
In the prospectively designed study presented at SABCS, researchers used Oncotype DX to analyze tumor samples from 1,231 patients in the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial.
The study looked at nine-year distant recurrence for women whose disease had spread to the lymph nodes and were on anastrozole and tamoxifen monotherapy in the ATAC trial.  The study was conducted by researchers at the Royal Marsden Hospital, and was supported by Breakthrough Breast Cancer, a leading breast cancer charity in the UK, and AstraZeneca. The partners collected tumor blocks mostly from patients in the UK and assessed the impact on patient outcomes when treatment decision were made using the Oncotype DX Recurrence Score, along with clinical factors such as age, tumor size, grade and treatment, and the Adjuvant! Online risk assessment tool.
In the study, researchers found that the Oncotype DX Recurrence Score had a statistically significant prognostic value beyond the prognosis of the Adjuvant! risk assessment tool in both node-negative (p<0.001) and node-positive (p=0.003) patients. Patients in the ATAC trial who were on anastrozole had greater efficacy and the similar hazard ratios for the recurrence score in both treatment arms. This finding “suggests a lower risk of recurrence in patients treated with aromatase inhibitors,” the researchers said in a statement. In addition, an increase likelihood of distant metastases was noted for any recurrence score when patients presented with greater numbers of positive nodes.
"Our multivariate analysis confirms that along with other standard measures such as tumor size, Oncotype DX contributes independently to providing a more complete picture of prognosis," Mitch Dowsett of Royal Marsden Hospital and lead author of the study said in a statement. "Physicians can take this information into account when making chemotherapy treatment decisions for both node-negative and node-positive early-stage breast cancer patients planned for either anastrozole or tamoxifen treatment."
This is the largest study Genomic Health has conducted to date for Oncotype DX, according to the company.
Another study presented by Genomic Health at the conference found that quantitative RT-PCR analysis is possible in ductal carcinoma in situ that is adjacent to invasive ductal carcinoma. “Of the 30 ER-positive breast cancer tumor samples that were identified, 90 percent had sufficient RNA for Oncotype DX analysis, after separating the DCIS and IDC tissues,” researchers said in a statement. “While DCIS adjacent to invasive breast cancer demonstrated similar quantitative biology for the genes evaluated in the Oncotype DX assay, future studies to evaluate Oncotype DX and recurrence rates in DCIS are needed.”
Genomic Health officials previously announced plans to expand Oncotype DX’s use into other cancer populations and indications.

FDA Approves Roche's Cobas Multiplex Test for HIV, Hepatitis Screening in Donated Blood

The US Food and Drug Administration said this week that it has approved Roche’s Cobas TaqScreen MPX Test for screening for the presence of different types of HIV in donated blood plasma and tissue.

The test detects HIV-1 Group O, HIV-1 Group M, HIV-2, and the hepatitis B and C viruses.
The MPX test is approved for use with plasma specimens from human donors of whole blood and blood components, but not for testing donated source plasma, FDA said. It is also intended for screening tissue specimens obtained while the donor’s heart is still beating.
“With the MPX test, blood donor testing laboratories will be able to use nucleic acid technology to screen for additional HIV strains, further assuring that donated blood and tissue are free from infection and providing better protection for patients,” said Jesse  Goodman, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

Toronto Clinic to Offer PGXL's Warfarin Test to Canadian Clients
The Medcan Clinic in Toronto will offer a genetic test that predicts patient response to the anti-clotting drug warfarin in Canada, under an agreement it signed with PGXL laboratories.
Medcan, a preventive health care clinic focused on identifying health risks before symptoms occur, said on Dec. 18 that it has signed an agreement with Louisville, Ky.-based PGXL to offer the warfarin test, which detects variations in the CYP2C9 and VCORC1 genes that are linked to warfarin response.
Medcan said that the agreement with PGXL also includes tests for “many other drug therapies,” but did not elaborate.
Medcan said that it is the first clinic to offer genetic testing for warfarin response in Canada. 
Financial terms of the agreement were not released.

Analyst Sees Obama Appointees as Favorable to Increased NIH Genomics Spending
Leerink Swann analyst Isaac Ro released a research note last week saying that he views the recent science advisors appointed by President-elect Barack Obama as a sign that the incoming administration “continues to take steps favorable to improved NIH funding, particularly for genomics-based research.”
Earlier last week, Obama selected Broad Institute Founding Director Eric Lander and former NIH Director Harold Varmus to serve as co-chairs for the President’s Council of Advisors on Science and Technology.
“We think increased funding in favor of high-density genotyping and next-generation sequencing is now more likely to continue under the Obama Administration, thanks to these appointments,” Ro wrote. He added that while life science tool firms will benefit to some degree from increased NIH funding, “we think investors should continue to stick with names closely levered to NIH funding and genomics research.”
Ro recommended two firms in particular that would benefit from a better-funded NIH: Illumina and Life Technologies. He currently has “Outperform” ratings on both firms.
Two weeks ago, Leerink Swann downgraded several firms in the life science tools space and lowered its 2009 revenue estimates for some as well, citing a survey that found that around two-thirds of university-based life science researchers are seeing reductions in their budgets.

Case Medical Center to Offer Exact's DNA Screening Test for Colon Cancer
Molecular diagnostics firm Exact Sciences said last week that University Hospitals Case Medical Center of Cleveland has launched a program for stool-based DNA screening at two sites within its system.
Marlborough, Mass.-based Exact Sciences makes a stool-based DNA test for colorectal cancer screening, which is offered by licensing partner Laboratory Corporation of America. Earlier this year, its screening technology was included in the American Cancer Society’s updated guidelines for colorectal cancer screening.
According to the firm, its stool-based DNA test will be the preferred method for screening patients who are unwilling or unable to obtain a colonoscopy. Exact’s test screens for the Vimentin gene, which was discovered by a researcher at Case Western Reserve University.
The center intends to evaluate the program's performance to determine whether it will roll out the DNA screening program system-wide.
Case Medical Center’s decision to offer the stool-based DNA screening test follows an announcement last week by the Massachusetts Department of Public Health that it had added the test as an option for its Massachusetts Care Coordination Program for low-income men and women over age 40.

Survey: Four Out of Five Americans Want Genetic Testing Made More Available
A majority of Americans support advancing genetics research and genetic testing, although more than one third are concerned about the safety guarantees of such science, according to a public opinion survey of public attitudes about biomedical science.
According to Virginia Commonwealth University’s Life Sciences Survey 2008, 80 percent of Americans favor making genetic testing “easily available to all who want it,” around the same amount who felt that way in 2001 and in 2004.
Americans also see genetics as playing a role in their lives, with 45 percent of adults saying that they have a disease or a medical condition that is “strongly related to genetic factors,” an increase of 7 percent over the 2007 survey. The margin of error for the survey is plus or minus 3.8 percentage points.
The study, which included 1,005 adults interviewed via telephone, also found that 54 percent believe that the benefits of genetic testing outweigh the risks, while 25 percent saw the risks as too great, and 21 percent did not know or refused to answer. That breakdown in opinions has changed slightly over the past eight years, with 57 and 58 percent in 2001 and 2004, respectively, believing that the benefits of genetic testing outweigh the risks.
Among the 80 percent who support making genetic tests easily available to all who want them, 38 percent were “somewhat” in favor of such access and 42 percent were “strongly” supportive.
VCU said that the concerns the public had about genetic research vary, as 38 percent thought that “too little is known about how to conduct such research safely,” 28 percent were concerned that the research may “violate moral principles,” and 21 percent had worries about the potential for discrimination.
Few of those surveyed felt that the government could protect them from any potential perils of genetic research, with 53 percent saying that it could not protect the public from such harms, down slightly from the 57 percent who held that view in the 2007 survey. VCU found that 17 percent believed that the government could keep them safe from such problems.
“The groups with more information about genetics are more likely to give a skeptical response to the idea that government regulation will protect the public from risks linked to genetic science,” VCU said, with those who had more information about science and medicine holding this view more strongly than those who did not.
The survey found that 57 percent of respondents believe that the environment and living practices, not genes, are more important influences on behavior, while 27 percent see it oppositely, and 16 percent did not provide answers or said ‘neither/both’ were important.
Similar belief patterns held for attitudes about disease with 66 percent disagreeing with the idea that “a person’s likelihood for disease is pretty much set from birth,” while 29 percent agreed with that statement.

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The Scan

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