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IRVINE, Calif. & AMSTERDAM–(BUSINESS WIRE)–Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces the appointment of Gabriel N. Hortobagyi, MD, FACP, FASCO, as Chair of its Medical Advisory Board. Dr. Gabriel Hortobagyi is an internationally recognized expert in clinical and translational research of breast cancer and brings more than 35 years …

IRVINE, Calif. & AMSTERDAM–(BUSINESS WIRE)–Agendia, Inc., a world leader in personalized medicine and molecular
cancer diagnostics, announces the appointment of Gabriel N. Hortobagyi,
MD, FACP, FASCO, as Chair of its Medical Advisory Board. Dr. Gabriel
Hortobagyi is an internationally recognized expert in clinical and
translational research of breast cancer and brings more than 35 years of
experience as a Breast Medical Oncologist. He is Professor and Chair
Emeritus of the Department of Breast Medical Oncology at the MD Anderson
Cancer Center (MDACC) and is also the past President of the American
Society of Clinical Oncology (ASCO). He is currently the Chair of the
Southwest Oncology Group Breast Committee and a member of the Scientific
Advisory Board of The Breast Cancer Research Foundation.
“I am thrilled for the opportunity to advise one of the leading
molecular diagnostic companies in the industry,” said Dr. Hortobagyi.
“Their cancer diagnostic tests, including MammaPrint and BluePrint are
some of the most advanced in genomic testing field. In fact, with the
recent MINDACT trial results, MammaPrint now has the highest level of
evidence a breast cancer diagnostic test can achieve. The additional
clinical and genomic data from that trial has the potential to
significantly advance the field of breast cancer oncology even further.”
The company also announced that it will be presenting new prospective
data for the MammaPrint 70-gene assay at the 2016 American Society of
Clinical Oncology (ASCO) Annual Meeting, which takes place on June 3-7
in Chicago. The recently completed PROMIS study (PRospective
Study Of MammaPrint in Patients With an Intermediate
Recurrence Score
) evaluates the clinical impact of the
definitive MammaPrint result in 831 ER+, LN- (lymph node negative)
breast cancer patients, who were previously given an
indeterminate/intermediate result with the 21-gene assay OncotypeDx (RS
18-30 clinical range, 11-25 trial range for 39-67% of tested patients).
The PROMIS poster will be presented on Sunday, June 5 from 8 a.m. to
11:30 a.m. CT. Michaela Tsai, MD, one of the four principal
investigators of PROMIS, will present the study. Agendia will
also be exhibiting at ASCO in Exhibit Booth #22109, from June 4-6 during
Exhibit Hall hours (9 a.m. – 5 p.m.).
Session: Breast Cancer – HER2/ER
Session Title: The
70-gene signature to provide risk stratification and treatment guidance
for patients classified as intermediate by the 21-gene assay

Location:
Hall A, McCormick Place
Poster Session: Board #59 / Abstract
#571
Agendia, Inc., together with the European Organisation for Research and
Treatment of Cancer (EORTC) and Breast International Group (BIG),
presented results from the initial analysis of the primary objective of
the Microarray In Node-negative (and 1 to 3 positive lymph node) Disease
may Avoid ChemoTherapy (MINDACT) study at the American Association for
Cancer Research Annual
Meeting 2016
in New Orleans in April 2016. As a follow-up to the
primary analysis, scientific data reviews will be available at the
Agendia Exhibit Booth (#22109) at ASCO as well.
The MINDACT trial is the first prospective randomized controlled
clinical trial of a breast cancer recurrence genomic assay with level 1A
clinical evidence and the first prospective translational research study
of this magnitude in breast cancer to report the results of its primary
objective.
“The positive results of the MINDACT trial along with the new PROMIS
results, add further proof that the data evaluating the clinical value
of MammaPrint are the most robust in the industry,” said Mark Straley,
Chief Executive Officer at Agendia. “With our strong clinical trial
results, our robust pipeline of products, and the recent appointments of
Dr. Hortobagyi to our advisory board and Dr. Audeh as our new Chief
Medical Officer, we’re making exciting advances in our continued pursuit
to bring more effective, individualized treatments within reach of
cancer patients.”
MINDACT included 6,693 patients and is a phase III, prospective,
randomized controlled, clinical trial comparing the use of MammaPrint
70-gene assay with clinical-pathological criteria (current standard of
care) for selecting early breast cancer patients who should be treated
with adjuvant chemotherapy.
For more information on Dr. Hortobagyi, PROMIS or MINDACT, please visit
the Agendia newsroom: http://www.agendia.com/agendia-news-and-press-releases/.
About Agendia
Agendia is a privately held, leading molecular
diagnostics company that develops and markets FFPE-based genomic
diagnostic products, which help support physicians with their complex
treatment decisions. Agendia’s breast cancer and colorectal cancer tests
were developed using an unbiased gene selection by analyzing the
complete human genome. Our offerings include the FDA-cleared MammaPrint®
FFPE 70-gene assay as well as the BluePrint® 80-gene molecular subtyping
assay that provides deeper insight, leading to more clinically
actionable biology. These tests can help physicians assess a breast
cancer patient’s individual risk for metastasis – that is, which
patients are more sensitive to chemo, hormonal, or combination therapy,
and which patients may not require these treatments and which patients
may be treated with other, less arduous and costly methods.
In addition, Agendia has a pipeline of other genomic products in
development. The company collaborates with pharmaceutical companies,
leading cancer centers and academic groups to develop companion
diagnostic tests in the area of oncology. It is also a critical partner
in the ISPY-2, NBRST and the MINDACT trials. For more information, visit www.agendia.com.

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