'Artificial Insemination: An Update' - Campus Workshop Announced By ESHRE

The course will cover all aspects of artificial insemination, including health economics and cost-effectiveness, European regulations and reproductive tourism, European IUI monitoring as well as methodological and ethical aspects



Here some of the new research findings that fertility experts from in and outside of Europe will announce:
The evidence of insemination versus intercourse or IVF


Born in the USA! Cost effectiveness of intrauterine insemination versus IVF


Choose your sex - ethical aspects of gender selection


Bank your future. Insemination and semen cryopreservation


Reproductive tourism for insemination due to different regulations


The European tissue directive and IUI


Europe is watching you. European regulations on artificial insemination


ESHRE Capri Guidelines on IUI


* Risk factors for high order multiples births following artificial insemination

Reproductive medicine is one of today's most exciting scientific and clinical areas. Every month brings announcements of research developments, medical 'firsts', new rulings by regulatory bodies, or ethical controversies - often sparking a heated debate among practitioners in the field themselves, as well as ethicists, legislators, the media and the public. ESHRE's activities provide the media with the opportunity to hear the latest research news and interview the experts.



The official language of the course is English. For a detailed program please visit: eshre/page.aspx/723



For this course due to time restrictions you can only register onsite.



Source: Hanna Hanssen


European Society for Human Reproduction and Embryology

Genomic Health Announces Multiple New Findings On Oncotype DX(TM) Based On Evaluation Of More Than 20,000 Tumor Samples

Genomic Health, Inc.
(Nasdaq: GHDX) today announced the results of several studies looking at
the roles and relationships of genes measured by the company's Oncotype DX
breast cancer assay, including an analysis of more than 10,000
node-negative tumors indicating that all 21 genes impact the assessment of
an individual woman's tumor. This research was presented at the 29th Annual
San Antonio Breast Cancer Symposium.



Oncotype DX measures the expression of 16 cancer-related genes plus 5
reference genes of an individual tumor to generate a "Recurrence Score" to
quantify risk of recurrence and likelihood of response to chemotherapy. To
assess the degree to which components of this multi-gene assay influence
the Recurrence Score, researchers measured expression of the 16 individual
cancer genes relative to reference genes in 10,618 tumor specimens on a
scale of 0 to 15, where a one-unit increment is associated with a twofold
change in expression. Results suggest that every cancer gene used in the
Oncotype DX 21-gene panel impacts the Recurrence Score due to the
potentially large variation in quantitative expression for each gene in
different patients. The study found this result even though expression of
certain genes and gene families; including ER, HER2 and a group of five
genes linked to proliferation, have the largest coefficients used in
calculating the Recurrence Score.



"Our ongoing clinical work is generating an abundance of useful and
important data, as evidenced by the collective findings presented in San
Antonio," said Steven Shak, M.D., chief medical officer of Genomic Health.
"With standardized quantitative measurements now analyzed in 20,000-plus
tumor samples, Genomic Health has the unique opportunity to generate and
share knowledge about the biology of breast cancer, which may lead to the
development of more effective individualized treatment for breast cancer
patients."




Study of 20,000 Samples Finds Heterogeneity in Three Breast Cancer
Subtypes



A second study, conducted in the same cohort of 10,618 tumor samples
plus an additional 9,432 samples analyzed recently for a total of 20,050
samples, used RT-PCR analysis as measured by Oncotype DX to identify the
breast cancer subtypes revealed by a standardized quantitative expression
assay. Three major subtypes of breast cancer were identified: patients with
ER-positive and HER2-negative disease; those with HER2-positive disease;
and those negative for ER, HER2 and the progesterone receptor (PR), or
triple negative breast cancer. These three subtypes have been proposed
previously, but the standardized quantitative Oncotype DX test revealed
that there is significant heterogeneity within each subtype that is likely
to be important for individualizing treatment. These results may help
explain why patients with each subtype respond so differently to treatment,
and underscore the importance of standardized measurement of gene
expression as a clinical tool.

















Study of 20,000 Samples Shows Proliferation Genes and Hormone Genes
Provide Independent Assessment




In a third study using the same 20,050 tumor samples, Genomic Health
investigators examined whether genes linked to proliferation were
associated with hormone and growth factor receptors. The hormone receptor
genes, ER and PR, as well as the HER2 growth factor receptor gene, are
well-known markers for disease risk and treatment success; however, the
analysis found that the expression of the proliferation genes was largely
independent of the hormone and growth factor receptor genes. These results
may explain why distinct contributions of multiple genes are required to
characterize the biology and treatment of individual breast cancers.



Kaiser, NSABP Study Finds ER Predictive, PR Prognostic



Separately, Genomic Health, the Pittsburgh-based National Surgical
Adjuvant Breast and Bowel Project (NSABP) and Kaiser Permanente presented
findings from a study that assessed whether PR expression and ER expression
were associated with disease prognosis or were predictive of response to
adjuvant therapy with tamoxifen.



Researchers used Oncotype DX to measure the association between PR and
ER expression and outcomes in more than 1,000 patients from two previously
conducted Kaiser and NSABP studies. In both studies, expression of ER was
associated with how a patient benefits from treatment with tamoxifen, but
was not significantly associated with prognosis in untreated patients,
indicating that it is a predictive factor. In contrast, these findings
showed PR to be a characteristic of disease progression, or prognostic
factor, but not predictive of benefit from tamoxifen. These results
indicate that not all women with estrogen receptor-positive breast cancer
benefit equally from tamoxifen.



"Over the years there have been conflicting reports about the relative
roles of ER and PR as prognostic and/or predictive factors in breast
cancer," said Norman Wolmark, M.D., chairman of the National Surgical
Adjuvant Breast and Bowel Project (NSABP), and the Department of Human
Oncology at Allegheny General Hospital in Pittsburgh, Pennsylvania. "Thanks
to these findings, which suggest very distinct roles, we believe we can
better chart how a woman's disease will progress and whether she's likely
to respond to hormone therapy based on her individual quantitative PR and
ER measurements."



About Oncotype DX



Oncotype DX represents the first diagnostic multi-gene expression test
service commercially available that has clinical evidence validating its
ability to predict the likelihood of breast cancer recurrence, the
likelihood of patient survival within 10 years of diagnosis and the
likelihood of chemotherapy benefit. Oncotype DX has been extensively
evaluated in multiple independent studies involving more than 2,600 breast
cancer patients, including a large validation study published in The New
England Journal of Medicine and a chemotherapy benefit study published in
the Journal of Clinical Oncology. For more information about Oncotype DX,
please visit oncotypedx.




About Genomic Health



Genomic Health, Inc. (Nasdaq: GHDX) is a life science company focused
on the development and commercialization of genomic-based clinical
laboratory services for cancer that allow physicians and patients to make
individualized treatment decisions. In 2004, Genomic Health launched its
first test service, Oncotype DX(TM), which has been shown to predict the
likelihood of breast cancer recurrence and the likelihood of chemotherapy
benefit in early-stage breast cancer patients. The company was founded in
2000 and is located in Redwood City, California. For more information, please visit genomichealth.



Forward Looking Statements



This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, including
statements relating to the conclusions suggested by research results, the
continued usefulness and importance of data generated by ongoing clinical
work, the potential for Genomic Health to develop more effective
individualized treatments for breast cancer patients, the significance of
various clinical outcomes and possible future uses for Oncotype DX, Genomic
Health's expectations regarding additional studies and expansion of the
clinical utility of Oncotype DX, its potential effect on clinical practice
and treatment decisions for patients, and the applicability of clinical
study results to actual outcomes. Forward-looking statements are subject to
risks and uncertainties that could cause actual results to differ
materially. These risks and uncertainties include the risks set forth in
our Quarterly Report on Form 10-Q for the quarter ended September 30, 2006,
which is on file with the Securities and Exchange Commission and is
available on the SEC's website at sec. These forward-looking
statements speak only as of the date hereof. We disclaim any obligation to
update these forward-looking statements.


Genomic Health, Inc.

genomichealth

N.J. Assembly Passes Bills To Fund Family Planning Clinics, Expand Medicaid Eligibility

The New Jersey Assembly on Monday passed two bills that would restore funding to family planning clinics and expand eligibility for Medicaid coverage of family planning services, the Asbury Park Press reports. The bills now go to the Senate for consideration in early December.

The bills passed along party lines, but neither received the 54 votes needed to override a possible veto by Gov. Chris Christie (R). In June, Christie vetoed similar legislation that would have reversed state budget cuts to family planning clinics, and the Senate failed to override the measure on a party-line vote.

One of the bills (A 3274) would transfer $5 million in reserve funding to state family planning clinics. The measure passed 45-25 with nine abstentions. The bill would prohibit the money from being used to pay for abortion services. Republican critics of the measure argue that the funds would allow family planning clinics that provide abortions to use other sources of revenue for the procedure.

The other bill (A 3273), which passed 44-25 with 10 abstentions, would require New Jersey to apply to the federal government to expand Medicaid coverage for family planning services to people with incomes between 133% and 200% of the federal poverty level, as allowed under the federal health reform law (PL 111-148). Twenty-seven states already have secured federal permission for such expansions. If approved, New Jersey would receive more than $15 million in federal funds over two years by spending $1.1 million in state funds (Symons, Asbury Park Press, 11/22).


Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.


© 2010 National Partnership for Women & Families. All rights reserved.

Warner Chilcott Files Suit Against Watson Laboratories Over Application For Generic Version Of Chewable Oral Contraceptive

Warner Chilcott has filed a federal lawsuit against Watson Laboratories in response to Watson's filing of an Abbreviated New Drug Application with FDA to market a generic version of Warner's chewable oral contraceptive Femcon Fe prior to the expiration of Warner's patent in 2019, Dow Jones reports (Derpinghaus, Dow Jones, 10/1). The lawsuit was filed in a U.S. District Court in New Jersey (Warner release, 10/1).

FDA in November 2003 approved the chewable version of Northern Ireland-based Galen Holdings' oral contraceptive Ovcon 35. The chewable pills, which Bristol-Myers Squibb manufactures, contain progestin and estrogen -- the same hormones used in standard birth control pills. Women will be able to chew the pills or swallow them whole; women who chew the pills must drink an eight-ounce glass of water afterward to ensure that the full dose reaches their stomachs. Femcon Fe has similar side effects to other birth control pills, such as an increased risk for blood clots, heart attack and stroke. One month's supply of the pill costs $44 wholesale.

Warner filed a lawsuit against Barr Laboratories in September for its FDA application for its generic version of Femcon Fe. Barr in April filed the FDA application to produce a generic version of the pill, and in August the company received notification of the application's acceptance for filing from the agency. Barr has said it is challenging Chilcott's patent for Femcon Fe, stating that it was the first to file an Abbreviated New Drug Application with FDA. FDA has placed a 30-month stay on action on Barr's application because of the suit (Kaiser Daily Women's Health Policy Report, 9/26). The agency also will place a 30-month stay on Watson's action in response to the lawsuit (Warner release, 10/1).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.