MARSEILLE, France - The Genomic HR Test Will Help Pathologists to Identify Endocrine-Responsive Tumors That Should Benefit From Hormonotherapy
Ipsogen SA (Alternext - FR0010626028 - ALIPS), a molecular diagnostic company specialized in the development, manufacturing and commercialization of diagnostic assays for breast cancer and leukemia, today announces the European launch of the MapQuant Dx(TM) HR test. Running on an Affymetrix microarray diagnostic platform, this new genomic test will improve the identification of endocrine-responsive tumors by measuring the expression of genes related to oestrogen and progesterone biology in breast cancer.
Current issues with endocrine-responsiveness determination in breast cancer
Determining endocrine-responsiveness of breast cancer is essential as it guides the use of hormonotherapy, based primarily on tamoxifen and aromatase inhibitors such as letrozole and anastrozole. Currently, endocrine-responsiveness is routinely assessed by immunohistochemistry (IHC), a semi-quantitative method measuring the expression of hormone receptors (HR) for estrogen (ER) and progesterone (PR) on tissue sections. However, and despite constant efforts toward technical standardisation, IHC reproducibility and accuracy is not satisfactory, with as much as 15% of cases reported as equivocal. This may lead to inappropriate treatment decisions.
Beyond the technical and standardisation issues, two biological problems are unsolved: (i) do ER-/PR+ tumors exist, or should they be considered as technical artifacts? (ii) how to define the threshold for receptor positivity (which is different in US and EU pathology practices)?
MapQuant Dx(TM) Genomic HR
The Genomic HR test measures the hormone receptor status of invasive breast tumors. It has been developed on a training set of 137 tumors with unequivoqual receptor expression by IHC. It was validated in 7 independent datasets totalling 691 tumors. It measures, by microarray technology, the expression profile of genes selected to best discriminate tumors expressing ER and/or PR proteins. These genes, selected on a statistical rationale, are known to be related to the estrogen and progesterone biology, adding a strong pathological rationale to the selection process.
Through this micro-array technique, an objective and biologically-relevant cutoff for receptor positivity could be identified. Over 97% of tumors could be given an unequivocal result. Moreover, no tumor expressing PR but nor ER could be identified, supporting the current hypothesis that such PR+/ER- tumors could be artifacts of the IHC technique.
Multi-testing with MapQuant Dx (TM)
Together with the Genomic Grade test and the Genomic HER2 test, the Genomic HR test provides a complete genomic testing panel for breast cancer that will help pathologists to better determine tumor grade, HR and HER2 status, and, ultimately, allow a more individualised treatment decision in breast cancer patients.
The Genomic HR test is made available for diagnostic use in Europe through an ISO-17025/CLIA Lab Service performed by DNAVision SA (Gosselies, Belgium). It can also be performed directly by cancer care centers equipped with the CE-marked, FDA-cleared Affymetrix GeneChip(R) 3000Dx2 (GCS3000Dx2) system.
The MapQuant Dx(TM) testing solution for routine micro-array profiling of breast tumors also includes: a Path Kit, CE-marked, ensuring easy sampling, RNA-preservation and sample shipping at ambient temperature; and CE-compliant software, ensuring highly reliable quality controls, data processing and genomic test computation.
MapQuant Dx(TM) testing solution is developed under the Innovation Support Programme of the French Health Products Safety Agency (Afssaps).
About IPSOGEN
Ipsogen, Cancer Profiler, develops and markets molecular diagnostic tests designed to map diseases in order to guide patients and oncologists’ decisions along their complex therapeutic path.
With more than 70 references already used routinely worldwide for the diagnosis, prognosis and follow-up of thousands of patients with leukemia, Ipsogen is now also targeting breast cancer. Its initial goal will be to provide diagnostic information that was not availble until now. Ipsogen is also a partner of choice for biopharmaceutical companies committed to the development of ‘companion diagnostic’ tests.
Strengthened by its first-rate scientific, clinical and technological partnerships, in addition to its highly skilled multidisciplinary team in France and the USA, Ipsogen is striving to become the leader in molecular profiling of cancers. It continues its efforts to indentify, develop and commercialise diagnostic tests that will become standard references and will have a significant impact on patients, medical professionals and society.
Ipsogen employed 51 people as of March 31, 2009. Its headquarters are located in Marseille, France. The company also has a subsidiary, Ipsogen Inc., in New Haven, CT, USA.
For more information, visit: www.ipsogen.com
Source: Ipsogen SA
Contacts: IPSOGEN, Vincent Fert, President and CEO, Tel: +33-(0)4-9129-3090, fert at ipsogen.com. Hélène Peyro-Saint-Paul, CMO, Tel: +33-(0)4-9129-3090, peyro-saint-paul at ipsogen.com. ATCG Press, Corporate and Product Information, Marielle Bricman, Tel: +33-(0)4-9125-0785, ipsogen at atcg-partners.com. NewCap, Financial Communication and Investor Relations, Axelle Vuillermet & Pierre Laurent, Tel: +33-(0)1-44-71-94-93, ipsogen at newcap.fr
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- Guidelines Specify that Validated Molecular Assays Should be Considered as an Adjunct to Standard Measures in Helping Determine Chemotherapy Benefit -
Genomic Health, Inc. (Nasdaq: GHDX) today reported that the St.
Agendia's Breast Cancer Recurrence Test MammaPrint Included in International St. Gallen Expert Consensus RecommendationsJune 22nd, 2009 HUNTINGTON BEACH, California and AMSTERDAM - International Expert Panel Recommends Use of Multigene Profiling Assays and Finds Intermediate Scores Lack Clinical Utility
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Sylvie van der Vaart's Operation was SuccesfullJune 15th, 2009 AMSTERDAM - One month ago, Sylvie van der Vaart was diagnosed with breast cancer in the early stages. Sylvie has since undergone a successful operation.
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Hurley and Bar Refaeli Introduce the Little Black BikiniApril 27th, 2009 LOS ANGELES - Beach Culture Brand and Sports Illustrated 2009 Swimsuit Issue Cover Star Collaborate to Create this Summer's Must-Have Swimsuit
Taking a cue from the number one women's wardrobe staple, the little black dress, Hurley and Bar Refaeli introduce the Little Black Bikini, a timeless essential for beaches everywhere. (Photo: www.newscom.com/cgi-bin/prnh/20090428/NY05330 ) (Logo: www.newscom.com/cgi-bin/prnh/20090210/NY68849LOGO-b )
The Little Black Bikini is the chic culmination of Hurley's proven expertise in swimwear and globetrotter Refaeli's experience modeling countless bathing suits for internationally renowned publications.
Ipsogen Announces the CE Marking of its "ProfileQuant(R) WT1" KitMarch 15th, 2009 MARSEILLE, France - WT1 is a Valuable Biomarker in the Prognosis and Follow-up
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announced that leading researchers from Agendia and the Netherlands Cancer
Institute will present data from multiple studies at the 2009 St.Gallen
Breast Cancer Conference. The St. Gallen Breast Cancer Conference, one of the
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Pink concert alerts Oz woman to her ballooning breast implantAugust 20th, 2009 CAIRNS - An Aussie woman, who woke up with one breast double the size of the other, said that had she not attended American singer Pink's concert, she would not have known there was a problem with her breast implant. Cattle station worker Kimberley Koy's breast had ballooned out overnight after a plane trip to Sydney to see Pink perform, and fearing that it might be breast cancer, she immediately visited her doctor.
Kerry Katona's boobs up for grabs!March 13th, 2009 LONDON - Pop singer Kerry Katona is auctioning off her fake boobs to raise funds for breast cancer charity. The 28-year-old former Atomic Kitten has put the 34GG silicone breast implant up for grabs on eBay, and has signed it "Lots of Love Kerry Katona", reports Daily Star.
Researchers locate what triggers breast, prostate cancersMarch 18th, 2009 WASHINGTON - Researchers have identified what triggers breast and prostate cancers. Ercole Cavalieri and Eleanor Rogen of University of Nebraska Medical Centre, who conducted the research, were quoted as saying in a Nebraska release: 'We have found the first step that starts a cell down the road to becoming a cancer cell'.
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What should teen girls do when they see lump in their breastJune 26th, 2009 WASHINGTON - When a teenage girl discovers a lump in her breast, she should go for ultrasound examination instead of going for an immediate excisional biopsy, suggested a study. Breast cancer is rare in adolescents, and a vast majority of teenage breast lumps turn out to be benign masses that are related to hormones.
Applegate's sense of humour helped her cope with cancerMarch 25th, 2009 WASHINGTON - Hollywood actress Christina Applegate, who was diagnosed with breast cancer last year, has revealed that it was her sense of humour that helped her cope with the disease. Applegate tells that "the only way to cope" with the disease was laughing throughout the painful treatment.
Kerry Katona's breast implants removed from eBayMarch 19th, 2009 WASHINGTON - Former Atomic Kitten member Kerry Katona has had her breast implants removed from eBay as they were unauthorized. Katona, 28, had apparently put the implants up on the auction site to raise funds for charity breastcancercampaign.org, but now they have been removed due to too many legal issues.
Why do men have nipples ?August 12th, 2009 There are lots of speculation about it, it is true that though women are having a logical purpose but why do men having nipples, some thought that it is the sign of being a mammal, some believe males are failed female, all unborn creature having a tendency to be shape up as a female but due to some reason they failed to be so and turned out as male. According to medical science male breast can also produce milk and can develop female breast diseases like breast cancer.
