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PR Newswire

Ajinomoto Althea, Inc. Launches Process and Analytical Development Services for Antibody Drug Conjugates (ADCs) Therapeutics

SAN DIEGO, Dec. 10, 2015 /PRNewswire/ — Ajinomoto Althea, Inc. (“Althea”), a leading provider of biopharmaceutical contract development and manufacturing services, recently announced it is expanding its existing biological drug product manufacturing operations to include highly active materials such as Antibody Drug Conjugates (ADCs). The new facility is located in close proximity to existing Althea operations in San Diego, CA.  Today Althea announced the first phase of its ADC and cytotoxic service offerings. Process and Analytical Development laboratories will be available for client programs in January 2016. These laboratories provide clients with services that support their early stage ADC product development efforts.  The Process Development labs are equipped to perform services such as bioconjugation, process development and optimization, ultrafiltration and diafiltration process development, as well as ADC material generation utilizing low Occupation Exposure Limit (OEL) payloads for pre-clinical studies. The Analytical Development labs will support process development services such as cleaning verification, raw material identification testing, ADC characterization assays, as well as necessary safety and potency assays.

Jason Brady, Ph.D., Sr. Director and Business Head, ADCs, states, “We are very excited to announce the implementation of this key first step of our ADC service offerings. Althea is very pleased with our progress towards offering ADC developers a simplified supply chain, including bioconjugation, fill and finish, and process and analytical development, all within a single US-based location.”

In addition to the development labs, Althea’s new state-of-the-art manufacturing facility will include areas dedicated to bioconjugation, formulation, purification, quality control, and aseptic fill finish including lyophilization. This 57,000 square foot facility will enable Althea to offer clients a simplified manufacturing supply chain service from a single United States based location. The facility has been designed for safe handling and manipulation of very low OEL compounds while maintaining aseptic conditions and GMP compliance. Client projects from early clinical phase through commercial launch and supply will be accommodated at this new facility.  

About Ajinomoto Althea, Inc.

Althea is a fully integrated, contract development and manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, analytical development, complex formulation, product release and ICH-compliant stability testing. Althea’s formulation technology platform includes Crystalomics®, a proprietary technology that offers a formulation solution for large molecule products that must be delivered at high concentrations or as sustained release formulations. Althea also has an innovative and proven recombinant protein expression technology called Corynex® technology. For more information visit us at www.altheaCMO.com

Logo – http://photos.prnewswire.com/prnh/20150126/171352LOGO

 

SOURCE Ajinomoto Althea, Inc.

[…]

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PR Newswire

Ajinomoto Althea, Inc. Launches Process and Analytical Development Services for Antibody Drug Conjugates (ADCs) Therapeutics

SAN DIEGO, Dec. 10, 2015 /PRNewswire/ — Ajinomoto Althea, Inc. (“Althea”), a leading provider of biopharmaceutical contract development and manufacturing services, recently announced it is expanding its existing biological drug product manufacturing operations to include highly active materials such as Antibody Drug Conjugates (ADCs). The new facility is located in close proximity to existing Althea operations in San Diego, CA.  Today Althea announced the first phase of its ADC and cytotoxic service offerings. Process and Analytical Development laboratories will be available for client programs in January 2016. These laboratories provide clients with services that support their early stage ADC product development efforts.  The Process Development labs are equipped to perform services such as bioconjugation, process development and optimization, ultrafiltration and diafiltration process development, as well as ADC material generation utilizing low Occupation Exposure Limit (OEL) payloads for pre-clinical studies. The Analytical Development labs will support process development services such as cleaning verification, raw material identification testing, ADC characterization assays, as well as necessary safety and potency assays.

Jason Brady, Ph.D., Sr. Director and Business Head, ADCs, states, “We are very excited to announce the implementation of this key first step of our ADC service offerings. Althea is very pleased with our progress towards offering ADC developers a simplified supply chain, including bioconjugation, fill and finish, and process and analytical development, all within a single US-based location.”

In addition to the development labs, Althea’s new state-of-the-art manufacturing facility will include areas dedicated to bioconjugation, formulation, purification, quality control, and aseptic fill finish including lyophilization. This 57,000 square foot facility will enable Althea to offer clients a simplified manufacturing supply chain service from a single United States based location. The facility has been designed for safe handling and manipulation of very low OEL compounds while maintaining aseptic conditions and GMP compliance. Client projects from early clinical phase through commercial launch and supply will be accommodated at this new facility.  

About Ajinomoto Althea, Inc.

Althea is a fully integrated, contract development and manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, analytical development, complex formulation, product release and ICH-compliant stability testing. Althea’s formulation technology platform includes Crystalomics®, a proprietary technology that offers a formulation solution for large molecule products that must be delivered at high concentrations or as sustained release formulations. Althea also has an innovative and proven recombinant protein expression technology called Corynex® technology. For more information visit us at www.altheaCMO.com

Logo – http://photos.prnewswire.com/prnh/20150126/171352LOGO

 

SOURCE Ajinomoto Althea, Inc.

[…]

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PR Newswire

goBalto Activate chosen by ICON for Global Site Activation, Automation and Process Improvement

ICON implements Activate to accelerate study startup by reducing manual processes

SAN FRANCISCO, Dec. 9, 2015 /PRNewswire/ — goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced today that ICON has chosen goBalto to further bolster ICON’s clinical study startup process on a worldwide basis.

ICON is using goBalto‘s flagship product, Activate, for all global studies spanning more than 50 countries. ICON is benefiting from Activate’s robust library of country-specific workflows and management-based approach to site activation and has already integrated Activate with its CTMS and data warehouse, and has plans to integrate with its eTMF system.

Combining ICON’s improved processes and practices with Activate allows ICON to streamline study startup, provide real-time status updates to the entire clinical study team, and eliminate “hidden” communications created by relying on email and manual spreadsheets. ICON engages collaboratively with investigator sites using Activate to improve the communication process and to ultimately minimize the time to obtain critical documents.

Now with access to at-a-glance critical path study and country level reports, ICON brings enhanced service to its pharmaceutical, biotechnology, and medical device clients.

ICON is also using goBalto‘s Analyze module for reporting and providing insight across multiple studies and regions. Along with Activate, Analyze provides real-time visibility into study startup, making it easier to quantify team performance and discover meaningful patterns in study startup data.

Marie Keegan, VP and Global Functional Head, Study Start Up at ICON stated, “Accelerating study startup timelines is a key component of our ICONIK Informatics Hub strategy which combines industry leading technologies with best practices to help our clients take time and cost from their development programs. Following a comprehensive review of our study startup activities, we adopted a range of new processes and procedures that have streamlined our site activation. We supplemented this with the capabilities of goBalto‘s Activate and Analyze to drive our study startup process, and are seeing significant positive impact on cycle time, quality and productivity as a result.”

“The life sciences industry has recognized study startup as one of the worst performing areas in clinical trials,” said Jae Chung, goBalto‘s founder and president. “ICON is taking the lead in automating a cumbersome industry process, with the goal of getting medicines to those in need faster.”

About ICON plc

ICON plc is a global provider of outsourced development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specializes in the strategic development, management and analysis of programs that support clinical development – from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently operates from 77 locations in 38 countries and has approximately 11,700 employees. Further information is available at www.iconplc.com.

About goBalto

goBalto develops next-generation solutions that simplify and accelerate clinical study startup in the pharmaceutical, biotechnology, and medical device industries. Our management team has over 100 years of combined experience in the life sciences industry and enterprise software implementation. Our team has worked for such companies as Amgen, Genentech, Quintiles, Roche, Johnson & Johnson, and Model N. With a proven commitment to customer success, disruption, and study startup optimization, we’re changing the way our leading global pharma and CRO customers approach their business processes. Based in San Francisco, California, we have satellite offices in Pennsylvania and Singapore. For more information, visit www.gobalto.com.

Press contact:
Craig Morgan
415.671.4372
cmorgan@gobalto.com 

Logo – http://photos.prnewswire.com/prnh/20141118/159334LOGO

 

SOURCE goBalto, Inc.

[…]

No Picture
PR Newswire

goBalto Activate chosen by ICON for Global Site Activation, Automation and Process Improvement

ICON implements Activate to accelerate study startup by reducing manual processes

SAN FRANCISCO, Dec. 9, 2015 /PRNewswire/ — goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced today that ICON has chosen goBalto to further bolster ICON’s clinical study startup process on a worldwide basis.

ICON is using goBalto‘s flagship product, Activate, for all global studies spanning more than 50 countries. ICON is benefiting from Activate’s robust library of country-specific workflows and management-based approach to site activation and has already integrated Activate with its CTMS and data warehouse, and has plans to integrate with its eTMF system.

Combining ICON’s improved processes and practices with Activate allows ICON to streamline study startup, provide real-time status updates to the entire clinical study team, and eliminate “hidden” communications created by relying on email and manual spreadsheets. ICON engages collaboratively with investigator sites using Activate to improve the communication process and to ultimately minimize the time to obtain critical documents.

Now with access to at-a-glance critical path study and country level reports, ICON brings enhanced service to its pharmaceutical, biotechnology, and medical device clients.

ICON is also using goBalto‘s Analyze module for reporting and providing insight across multiple studies and regions. Along with Activate, Analyze provides real-time visibility into study startup, making it easier to quantify team performance and discover meaningful patterns in study startup data.

Marie Keegan, VP and Global Functional Head, Study Start Up at ICON stated, “Accelerating study startup timelines is a key component of our ICONIK Informatics Hub strategy which combines industry leading technologies with best practices to help our clients take time and cost from their development programs. Following a comprehensive review of our study startup activities, we adopted a range of new processes and procedures that have streamlined our site activation. We supplemented this with the capabilities of goBalto‘s Activate and Analyze to drive our study startup process, and are seeing significant positive impact on cycle time, quality and productivity as a result.”

“The life sciences industry has recognized study startup as one of the worst performing areas in clinical trials,” said Jae Chung, goBalto‘s founder and president. “ICON is taking the lead in automating a cumbersome industry process, with the goal of getting medicines to those in need faster.”

About ICON plc

ICON plc is a global provider of outsourced development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specializes in the strategic development, management and analysis of programs that support clinical development – from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently operates from 77 locations in 38 countries and has approximately 11,700 employees. Further information is available at www.iconplc.com.

About goBalto

goBalto develops next-generation solutions that simplify and accelerate clinical study startup in the pharmaceutical, biotechnology, and medical device industries. Our management team has over 100 years of combined experience in the life sciences industry and enterprise software implementation. Our team has worked for such companies as Amgen, Genentech, Quintiles, Roche, Johnson & Johnson, and Model N. With a proven commitment to customer success, disruption, and study startup optimization, we’re changing the way our leading global pharma and CRO customers approach their business processes. Based in San Francisco, California, we have satellite offices in Pennsylvania and Singapore. For more information, visit www.gobalto.com.

Press contact:
Craig Morgan
415.671.4372
cmorgan@gobalto.com 

Logo – http://photos.prnewswire.com/prnh/20141118/159334LOGO

 

SOURCE goBalto, Inc.

[…]

No Picture
PR Newswire

Genomic Health Announces Presentation of Eight Oncotype DX® Studies at the 2015 CTRC-AACR San Antonio Breast Cancer Symposium

New “Big Data” SEER Study Establishes Oncotype DX as the Only Multi-gene Breast Cancer Test with Industry-leading Level of Prospective Outcomes Evidence in Tens of Thousands of Patients

REDWOOD CITY, Calif., Dec. 9, 2015 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced that the company will present results from eight Oncotype DX® breast cancer test studies at the 38th CTRC-AACR San Antonio Breast Cancer Symposium (SABCS).  Presentations in invasive breast cancer, ductal carcinoma in situ (DCIS) and next-generation sequencing (NGS) include:

  • Prospective outcomes results from a large population observational study based on the Surveillance, Epidemiology, and End Results (SEER) registry program of the National Cancer Institute, the premier source of cancer statistics in the United States. The analysis provides important new insights into outcomes in more than 38,000 patients with node-negative and node-positive breast cancer treated prospectively with Oncotype DX Recurrence Score® results at diagnosis.
  • Single gene analysis from the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, one of the largest-ever adjuvant breast cancer treatment trials, which was designed and conducted by the ECOG-ACRIN Cancer Research Group under the sponsorship of the National Cancer Institute.  The first TAILORx results were recently published in The New England Journal of Medicine. The new analysis includes additional single gene results from patients with Recurrence Score results less than 11 who received hormonal therapy alone.
  • Prospective clinical outcomes results from a large, multi-center patient cohort from Clalit Health Services, the largest Health Maintenance Organization in Israel, where Oncotype DX was used to identify patients for treatment with hormonal therapy alone or with hormonal therapy plus chemotherapy since 2006.
  • A multi-center decision impact analysis evaluating the clinical utility of the Oncotype DX DCIS Score™ in driving radiation treatment recommendations by surgeons and radiation oncologists across 13 sites in the United States, providing a second independent study of the value of individualized risk estimates in personalizing treatment planning for patients with DCIS.
  • A gene discovery study conducted by the NCI cooperative group, SWOG, highlighting Genomic Health’s leadership in using NGS and bioinformatics tools to produce and analyze “big data” in gene discovery.

“We now have an unprecedented amount of prospective outcomes data from multiple independent studies that provide the highest level of evidence of the effectiveness of Oncotype DX in transforming breast cancer treatment decisions and outcomes, and look forward to sharing complete results in the coming days,” said Steven Shak, MD, chief scientific officer, Genomic Health.

Complete results from all of these studies will be announced next week in accordance with the SABCS embargo policy.  Following are details for each presentation (all times are in Central Standard Time):

Thursday, December 10

  • Abstract: P2-07-01
    Poster Session 2: “Association of TILs with clinical parameters, recurrence score, and prognosis in patients with early HER2-negative breast cancer (BC) – A translational analysis of the prospective WSG planB trial”
    Authors: Liedtke C, Gluz O, Heinisch F, Feuerhake F, Kreipe HH, Clemens M, Nuding B, Kraemer S, Reimer T, Svedman C, Shak S, Nitz U, Kates RE, Harbeck N, Christgen M.
    Location: Exhibit Halls A-B
    Time: 7:30 – 9 a.m.

 

  • Abstract: P2-08-01
    Poster Session 2: “Prospective trial of endocrine therapy alone in patients with estrogen receptor positive, HER2-negative, node-negative breast cancer: Results of the TAILORx low risk registry”
    Authors: Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer Jr CE, Dees EC, Perez EA, Olson Jr JA, Zujweski J, Keane MM, Gomez Moreno HL, Reddi RP, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Atkins JN, Berenberg JL, Sledge Jr GW.
    Location: Exhibit Halls A-B
    Time: 7:30 – 9 a.m.

 

  • Abstract: S3-02
    Oral Presentation in General Session 3: “Molecular predictors of outcome on adjuvant CAF plus tamoxifen (T) vs T in postmenopausal patients (pts) with ER+, node+ breast cancer – transcriptome expression analysis of the phase III trial SWOG-8814”
    Authors: Albain KS, Crager MR, Barlow WE, Baehner FL, Bergamaschi A, Rae JM, Ravdin PM, Tripathy D, Gralow JR, Livingston RB, Osborne CK, Ingle JN, Pritchard KI, Davidson NE, Carey LA, Cherbavaz DB, Sing AP, Shak S, Hortobagyi GN, Hayes DF.
    Location: Exhibit Hall D
    Time: 9:45 a.m.

Friday, December 11

  • Abstract: P5-17-03
    Poster Session 5: “The 12-gene DCIS Score assay: Impact on radiation treatment (XRT) recommendations utility”
    Authors: Manders JB, Kuerer HM, Smith BD, McCluskey C, Farrar WB, Frazier TG, Li L, Leonard CE, Carter DL, Chawla S, Medeiros LE, Guenther JM, Castellini LE, Buchholz DJ, Mamounas EP, Wapnir IL, Horst KC, Chagpar A, Evans SB, Riker AI, Vali FS, Solin LJ, Jablon L, Recht A, Sharma R, Lu R, Sing AP, Hwang ES, White J.
    Location: Exhibit Halls A-B
    Time: 5 – 7 p.m.

 

  • Abstract: P5-13-03
    Poster Session 5: “Fulvestrant plus anastrozole as neoadjuvant therapy in postmenopausal women with hormone receptor positive early breast cancer”
    Authors: Khan QJ, Barr JA, Britt AS, Kimler BF, Connor CS, McGinness M, Mammen JMV, Wagner JL, Amin A, Springer M, Baccaray S, Fabian CJ, Sing AP, Sharma P.
    Location: Exhibit Halls A-B
    Time: 5 – 7 p.m.

 

  • Abstract: P5-07-01
    Poster Session 5: “Successful whole transcriptome analysis of 25-year-old breast tumor samples from the phase III trial SWOG-8814 by next generation sequencing (NGS): Standardized analytical methods for exploratory and validation studies”
    Authors: Cherbavaz DB, Hayes DF, Qu K, Crager MR, Barlow WR, Goddard AD, Beasley EM, Jeong J, Collin F, Liu M-L, Rae JM, Ravdin PM, Tripathy D, Gralow JR, Livingston RB, Osborne CK, Ingle JN, Pritchard KI, Davidson NE, Carey LA, Sing AP, Baehner FL, Hortobagyi GN, Shak S, Albain KS.
    Location: Exhibit Halls A-B
    Time: 5 – 7 p.m.

 

  • Abstract: P5-08-02
    Poster Session 5: “Real-life analysis evaluating 1594 N0/Nmic breast cancer patients for whom treatment decisions incorporated the 21-gene Recurrence Score result”
    Authors: Stemmer SM, Steiner M, Rizel S, Soussan-Gutman L, Geffen DB, Nisenbaum B, Ben-Baruch N, Isaacs K, Fried G, Rosengarten O, Uziely B, Svedman C, Rothney M, Klang SH, Ryvo L, Kaufman B, Evron E, Zidan J, Shak S, Liebermann N.
    Location: Exhibit Halls A-B
    Time: 5 – 7 p.m.

 

  • Abstract: P5-15-01
    Poster Session 5: “Breast Cancer Specific Survival in 38,568 Patients with Node Negative Hormone Receptor Positive Invasive Breast Cancer and Oncotype DX Recurrence Score Results in the SEER Database”
    Authors: Shak S, Petkov VI, Miller DP, Howlader N, Gliner N, Howe W, Schussler N, Cronin K, Baehner FL, Penberthy L.
    Location: Exhibit Halls A-B
    Time: 5 – 7 p.m.

About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. With half a million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX breast cancer tests, visit: www.OncotypeDX.com or www.mybreastcancertreatment.org.

About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the world’s leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early-stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient’s journey, from diagnosis to treatment selection and monitoring. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealthFacebookYouTube and LinkedIn.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the benefits of the test to physicians, patients and payors. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the ability of test results to change treatment decisions; the risks and uncertainties associated with the regulation of the company’s tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; and the other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s quarterly report on Form 10-Q for the quarter ended September 30, 2015. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

Logo – http://photos.prnewswire.com/prnh/20130425/SF01493LOGO

 

SOURCE Genomic Health, Inc.

[…]

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PR Newswire

Genomic Health Announces Presentation of Eight Oncotype DX® Studies at the 2015 CTRC-AACR San Antonio Breast Cancer Symposium

New “Big Data” SEER Study Establishes Oncotype DX as the Only Multi-gene Breast Cancer Test with Industry-leading Level of Prospective Outcomes Evidence in Tens of Thousands of Patients

REDWOOD CITY, Calif., Dec. 9, 2015 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced that the company will present results from eight Oncotype DX® breast cancer test studies at the 38th CTRC-AACR San Antonio Breast Cancer Symposium (SABCS).  Presentations in invasive breast cancer, ductal carcinoma in situ (DCIS) and next-generation sequencing (NGS) include:

  • Prospective outcomes results from a large population observational study based on the Surveillance, Epidemiology, and End Results (SEER) registry program of the National Cancer Institute, the premier source of cancer statistics in the United States. The analysis provides important new insights into outcomes in more than 38,000 patients with node-negative and node-positive breast cancer treated prospectively with Oncotype DX Recurrence Score® results at diagnosis.
  • Single gene analysis from the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, one of the largest-ever adjuvant breast cancer treatment trials, which was designed and conducted by the ECOG-ACRIN Cancer Research Group under the sponsorship of the National Cancer Institute.  The first TAILORx results were recently published in The New England Journal of Medicine. The new analysis includes additional single gene results from patients with Recurrence Score results less than 11 who received hormonal therapy alone.
  • Prospective clinical outcomes results from a large, multi-center patient cohort from Clalit Health Services, the largest Health Maintenance Organization in Israel, where Oncotype DX was used to identify patients for treatment with hormonal therapy alone or with hormonal therapy plus chemotherapy since 2006.
  • A multi-center decision impact analysis evaluating the clinical utility of the Oncotype DX DCIS Score™ in driving radiation treatment recommendations by surgeons and radiation oncologists across 13 sites in the United States, providing a second independent study of the value of individualized risk estimates in personalizing treatment planning for patients with DCIS.
  • A gene discovery study conducted by the NCI cooperative group, SWOG, highlighting Genomic Health’s leadership in using NGS and bioinformatics tools to produce and analyze “big data” in gene discovery.

“We now have an unprecedented amount of prospective outcomes data from multiple independent studies that provide the highest level of evidence of the effectiveness of Oncotype DX in transforming breast cancer treatment decisions and outcomes, and look forward to sharing complete results in the coming days,” said Steven Shak, MD, chief scientific officer, Genomic Health.

Complete results from all of these studies will be announced next week in accordance with the SABCS embargo policy.  Following are details for each presentation (all times are in Central Standard Time):

Thursday, December 10

  • Abstract: P2-07-01
    Poster Session 2: “Association of TILs with clinical parameters, recurrence score, and prognosis in patients with early HER2-negative breast cancer (BC) – A translational analysis of the prospective WSG planB trial”
    Authors: Liedtke C, Gluz O, Heinisch F, Feuerhake F, Kreipe HH, Clemens M, Nuding B, Kraemer S, Reimer T, Svedman C, Shak S, Nitz U, Kates RE, Harbeck N, Christgen M.
    Location: Exhibit Halls A-B
    Time: 7:30 – 9 a.m.

 

  • Abstract: P2-08-01
    Poster Session 2: “Prospective trial of endocrine therapy alone in patients with estrogen receptor positive, HER2-negative, node-negative breast cancer: Results of the TAILORx low risk registry”
    Authors: Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer Jr CE, Dees EC, Perez EA, Olson Jr JA, Zujweski J, Keane MM, Gomez Moreno HL, Reddi RP, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Atkins JN, Berenberg JL, Sledge Jr GW.
    Location: Exhibit Halls A-B
    Time: 7:30 – 9 a.m.

 

  • Abstract: S3-02
    Oral Presentation in General Session 3: “Molecular predictors of outcome on adjuvant CAF plus tamoxifen (T) vs T in postmenopausal patients (pts) with ER+, node+ breast cancer – transcriptome expression analysis of the phase III trial SWOG-8814”
    Authors: Albain KS, Crager MR, Barlow WE, Baehner FL, Bergamaschi A, Rae JM, Ravdin PM, Tripathy D, Gralow JR, Livingston RB, Osborne CK, Ingle JN, Pritchard KI, Davidson NE, Carey LA, Cherbavaz DB, Sing AP, Shak S, Hortobagyi GN, Hayes DF.
    Location: Exhibit Hall D
    Time: 9:45 a.m.

Friday, December 11

  • Abstract: P5-17-03
    Poster Session 5: “The 12-gene DCIS Score assay: Impact on radiation treatment (XRT) recommendations utility”
    Authors: Manders JB, Kuerer HM, Smith BD, McCluskey C, Farrar WB, Frazier TG, Li L, Leonard CE, Carter DL, Chawla S, Medeiros LE, Guenther JM, Castellini LE, Buchholz DJ, Mamounas EP, Wapnir IL, Horst KC, Chagpar A, Evans SB, Riker AI, Vali FS, Solin LJ, Jablon L, Recht A, Sharma R, Lu R, Sing AP, Hwang ES, White J.
    Location: Exhibit Halls A-B
    Time: 5 – 7 p.m.

 

  • Abstract: P5-13-03
    Poster Session 5: “Fulvestrant plus anastrozole as neoadjuvant therapy in postmenopausal women with hormone receptor positive early breast cancer”
    Authors: Khan QJ, Barr JA, Britt AS, Kimler BF, Connor CS, McGinness M, Mammen JMV, Wagner JL, Amin A, Springer M, Baccaray S, Fabian CJ, Sing AP, Sharma P.
    Location: Exhibit Halls A-B
    Time: 5 – 7 p.m.

 

  • Abstract: P5-07-01
    Poster Session 5: “Successful whole transcriptome analysis of 25-year-old breast tumor samples from the phase III trial SWOG-8814 by next generation sequencing (NGS): Standardized analytical methods for exploratory and validation studies”
    Authors: Cherbavaz DB, Hayes DF, Qu K, Crager MR, Barlow WR, Goddard AD, Beasley EM, Jeong J, Collin F, Liu M-L, Rae JM, Ravdin PM, Tripathy D, Gralow JR, Livingston RB, Osborne CK, Ingle JN, Pritchard KI, Davidson NE, Carey LA, Sing AP, Baehner FL, Hortobagyi GN, Shak S, Albain KS.
    Location: Exhibit Halls A-B
    Time: 5 – 7 p.m.

 

  • Abstract: P5-08-02
    Poster Session 5: “Real-life analysis evaluating 1594 N0/Nmic breast cancer patients for whom treatment decisions incorporated the 21-gene Recurrence Score result”
    Authors: Stemmer SM, Steiner M, Rizel S, Soussan-Gutman L, Geffen DB, Nisenbaum B, Ben-Baruch N, Isaacs K, Fried G, Rosengarten O, Uziely B, Svedman C, Rothney M, Klang SH, Ryvo L, Kaufman B, Evron E, Zidan J, Shak S, Liebermann N.
    Location: Exhibit Halls A-B
    Time: 5 – 7 p.m.

 

  • Abstract: P5-15-01
    Poster Session 5: “Breast Cancer Specific Survival in 38,568 Patients with Node Negative Hormone Receptor Positive Invasive Breast Cancer and Oncotype DX Recurrence Score Results in the SEER Database”
    Authors: Shak S, Petkov VI, Miller DP, Howlader N, Gliner N, Howe W, Schussler N, Cronin K, Baehner FL, Penberthy L.
    Location: Exhibit Halls A-B
    Time: 5 – 7 p.m.

About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. With half a million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX breast cancer tests, visit: www.OncotypeDX.com or www.mybreastcancertreatment.org.

About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the world’s leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early-stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient’s journey, from diagnosis to treatment selection and monitoring. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealthFacebookYouTube and LinkedIn.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the benefits of the test to physicians, patients and payors. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the ability of test results to change treatment decisions; the risks and uncertainties associated with the regulation of the company’s tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; and the other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s quarterly report on Form 10-Q for the quarter ended September 30, 2015. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

Logo – http://photos.prnewswire.com/prnh/20130425/SF01493LOGO

 

SOURCE Genomic Health, Inc.

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