Quantcast

Industry news that matters to you.  Learn more

Study Published Showing Advantages of the PAM50 Gene Signature, the Basis for Prosigna, in Helping to Estimate Risk of Late Distant Recurrence in Postmenopausal Estrogen Receptor Positive Breast Cancer Patients

NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, recently announced that a study published online in the Journal of the National Cancer Institute demonstrated that the PAM50 gene signature, which is the basis for the Prosigna™ Breast Cancer Prognostic Gene Signature Assay, provides important information to help estimate the risk of late distant recurrence in postmenopausal women with estrogen receptor positive (ER+) early-stage breast cancer. After comparing the PAM50 gene signature, the Oncotype DX® Breast Cancer Assay and the IHC4 score, the authors concluded that the PAM50 gene signature provided the strongest prognostic information regarding risk of distant recurrence five to 10 years following diagnosis in postmenopausal ER+ early-stage breast cancer patients treated with five years of endocrine therapy.

Joint Assurex Health and Mayo Clinic Study Demonstrates Clinical Utility of Assurex Health’s Pharmacogenomic Test to Guide Treatment of Major Depressive Disorders

Assurex Health, a personalized medicine company focused on pharmacogenomics for neuropsychiatric disorders, recently announced the publication of a joint clinical study conducted by Assurex and Mayo Clinic which provides additional evidence for the effectiveness of the GeneSight pharmacogenomic test over the current method for selecting psychotropic medications. The study results were published on July 24, 2013 in Pharmacogenetics and Genomics. The primary outcome of the study showed a substantially greater baseline to endpoint decrease in depressive symptoms with higher rates of response and remission in the guided GeneSight group over empiric prescribing, which is the current standard of care. These results reinforce the benefit of GeneSight in providing more objective, evidence-based support for clinicians in selecting medications for patients with psychiatric disorders.

The prospective clinical trial, involving 227 participants divided into pharmacogenomic-guided treatment and treatment-as-usual groups, utilized the GeneSight interpretive report to categorize 26 antidepressants and antipsychotics into color-coded green, yellow, and red “bins” based on each participant’s genetic information and pharmacology of the medications. Significantly greater reductions in symptoms were observed for the GeneSight-guided group using multiple symptom rating scales completed by both clinicians and patients. Participants in the GeneSight-guided group experienced an overall greater than 2-fold improvement in both symptoms and likelihood to achieve remission.

Overall, results with GeneSight-guided treatment were superior to unguided treatment-as-usual. The study showed the ability of GeneSight to identify individuals who are likely to have a favorable outcome with specific pharmacotherapies, supporting the clinical utility of the GeneSight test. A four-fold greater improvement in depressive symptoms was observed in the GeneSight-guided group among participants who entered the study on medications most discordant (red-bin) with their pharmacogenomic profile.

Physicians for nearly 94% of patients in the GeneSight-guided group used the report to either switch participants off medications discordant with their genetics to medications in the green bin or to adjust medication dosages according to the participant’s GeneSight report.

These findings replicate and expand on the magnitude of the effect observed in a previous prospective joint clinical study from Assurex and Mayo Clinic published in Translational Psychiatry (Oct. 2012). This smaller study compared GeneSight-guided prescribing versus treatment-as-usual in adult patients with a primary diagnosis of a major depressive disorder over an 8 week period. Furthermore, a one-year blinded retrospective study of adult patients with a diagnosis of depressive or anxiety disorder published in Translational Psychiatry (Mar. 2013) demonstrated that patients taking discordant red bin medications based on the GeneSight report had substantially higher rates of medical utilization, 3-fold greater medical absence days, and 4-fold greater medical disability claims than patients on non-red bin medications.

“Multiple clinical studies have now demonstrated the clinical validity and clinical utility of our integrated, GeneSight combinatorial pharmacogenomic testing platform,” according to Bryan M. Dechairo, Ph.D., Senior Vice President, Medical Affairs & Clinical Development at Assurex Health. “Prescribing a medication regimen that is more likely to succeed because it is tailored to an individual patient’s genetic profile can help clinicians better manage each patient’s disorder and improve clinical outcomes.”

Source: PR Newswire

NICE Recommends Genomic Health’s Oncotype DX® Test To Guide Chemotherapy Treatment Decisions For Qualified Early-Stage Invasive Breast Cancer Patients

Genomic Health, Inc. recently announced that the National Institute for Health and Care Excellence (NICE) in the United Kingdom has issued its final guidance recommending Oncotype DX® as the only multi-gene breast cancer test for use in clinical practice to guide chemotherapy treatment decisions for patients with early-stage, hormone receptor-positive, invasive breast cancer. Consistent with leading international breast cancer treatment guidelines, including ASCO®, NCCN®, ESMO® and St. Gallen, NICE’s recommendation recognizes the unparalleled evidence of the clinical validity of the Oncotype DX test and its ability to enable physicians and their patients to make more informed, individualized decisions.

“It is encouraging to see growing recognition of the value of genomic testing. Its provision has enhanced the care of breast cancer patients around the world and it will now be available as an option in the UK,” said David Miles, M.D., medical oncologist at Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom. “NICE’s recommendation for the use of Oncotype DX in the UK is an important step forward, enabling physicians and patients to make better-informed treatment decisions based on the biology of an individual patient’s breast cancer.”

To date, more than 1,500 women in the UK have utilized the Oncotype DX test to help guide their treatment decisions. Breast cancer is the most commonly diagnosed cancer in women, with almost 50,000 people diagnosed each year in the UK. Most of these patients are diagnosed with early-stage, invasive breast cancer and a significant number of them could benefit from this test under the NICE recommendation.

“The decision of whether or not to undergo chemotherapy is an extremely important and difficult one for patients, not only due to the many side effects associated with treatment, but also due to the hardship for the patient and her family and the loss of income due to days off work. Allowing patients and their physicians to make more personalized treatment decisions can help improve outcomes for the rising number of early-stage breast cancer patients in Europe,” said Kathi Apostolidis, vice president, European Cancer Patient Coalition, Brussels, Belgium, and a two-time breast cancer survivor, commenting on the NICE announcement. “We hope NICE’s decision will also inspire other European countries to provide broader access to novel diagnostics such as Oncotype DX, which allows informed decision making for sparing the burden of chemotherapy from those who do not need it.”

With data showing that only four out of 100 early-stage invasive breast cancer patients benefit from chemotherapy, the Oncotype DX test helps improve patient outcomes by personalizing treatment decisions through assessment of the risk of cancer recurrence and chemotherapy benefit.

“Given NICE’s rigorous review process and its influence throughout the region, we believe this decision brings us an important step closer to achieving our mission to improve the quality of treatment decisions for cancer patients across Europe and around the world,” said Steven Shak, M.D., executive vice president of research and development, Genomic Health. “Our extensive body of clinical evidence highlights the unique ability of our test to play a critical role in breast cancer treatment, while providing a positive impact on health systems worldwide. Based on NICE’s recommendation, we will work with NHS healthcare providers and commissioners to provide broad access to the Oncotype DX test for UK patients.”

The robust body of evidence supporting Oncotype DX includes 15 clinical studies in more than 6,000 patients; 18 decision impact studies from 10 countries, which consistently demonstrate an approximate 30 percent change in treatment recommendations; and more than 20 studies from nine countries, showing that the use of the test is cost-effective in all health systems analyzed.

Source: PR Newswire

Assurex Health Appoints Veteran P&G Consumer Products Executive Virginia Coleman Drosos President to Lead Personalized Medicine Growth

Assurex Health, a personalized medicine company specializing in pharmacogenomics for neuropsychiatric and other disorders, recently announced that Procter & Gamble veteran Virginia “Gina” Coleman Drosos has joined its leadership team in the role of President.

Drosos joins Assurex Health with more than 25 years of global business leadership, innovation, operations and consumer marketing expertise. During her 25 year career at The Procter & Gamble Company (PG), Gina held positions of increasing responsibility in the United States and internationally delivering strong proven results. She most recently served P&G as Group President for Global Beauty Care, a $6 billion global business unit with over 6,000 employees in 120 countries. 

“Gina brings extensive leadership and strong results on global consumer-driven businesses,” said James S. Burns, CEO of Assurex Health. “I’m particularly excited about Gina joining the team because health care is rapidly moving into an era of patient-empowerment, leading a shift to consumer-enabled personalized medicine. In bringing neuropsychiatric pharmacogenomics to a market of 40+ million patients in the U.S. alone, Assurex will benefit from Gina’s experience in creating awareness and cultivating a huge base of patients/consumers/caregivers, 80% of whom are women as the primary medical decision maker.”

Assurex Health’s pharmacogenomic technology is a breakthrough in personalized medicine. Based on each patient’s personal genetic profile, GeneSight tests help clinicians determine the right treatment medications for patients with depression, ADHD, chronic pain and other neuropsychiatric disorders. “Eliminating today’s typical trial and error process for selecting medications can help people reclaim their lives and reduces healthcare costs,” said Drosos. “I look forward to applying my experience leading in the consumer space to help make personalized medicine a standard of care in the industry. With exciting new innovations in the pipeline and our technology-information-consumer platform, I’m confident Assurex will help more physicians and practitioners determine the best treatment options and lead the movement toward consumer-enabled personalized medicine.”

Drosos also serves on the Board of Directors for several major corporations including Signet Jewelers Ltd. (SIG) and American Financial Group (AFG). Drosos earned a Bachelor of Business Administration in Finance from the University of Georgia, a Master of Business Administration from The Wharton School, University of Pennsylvania, and was recognized as one of Fortune’s 50 Most Powerful Women in Business in 2010 and 2011.

Source: PR Newswire

Sanguine BioSciences Signs Agreements with More than 200 Partners to Enable Efficient Personalized Medicine Research

Sanguine BioSciences, a biotechnology company enabling personalized medicine research, today announced that it has signed commercial agreements with, and received orders from, more than 200 biomedical researchers at academic, biotechnology and pharmaceutical companies, to enable more efficient personalized medicine research. Ongoing agreements are in place with a wide range of organizations, ranging from startups, such as Inhibrx, to contract research organizations, such as Applied Immunology, and major drug developers, such as Vertex Pharmaceuticals.

Sanguine directly engages patients diagnosed with severe and chronic diseases to collect and de-identify biospecimen, medical history and other data that can be used in biomarker research. Traditional methods are to obtain biospecimen through hospitals, but this process can result in months of delays as the focus for physicians and staff is on diagnosis and treatment, not facilitating research efforts. By engaging patients directly, Sanguine can meet the needs of researchers and offer timely turnaround of biospecimen and medical data with diverse ranges for age, race, disease state, gender and treatments underway. The patient engagement tactics used by the company have led to a 95 percent retention rate, which also allow for follow-up draws for longitudinal studies.

“In a very short amount of time, and with only recently hiring our first few sales executives, our company has established agreements with ten of the largest drug developers in the world and continues to see high demand for our offering,” said Brian Neman, founder and chief executive officer of Sanguine. “Researchers have specific needs to complete studies in early discovery work, sometimes run with blood samples drawn the same day and other times requiring follow-up draws on exact time schedules, but traditional strategies to obtain these add months to the timeline. Our commitment to patient engagement, transparency and advocacy removes much of this wait time – accelerating the research and increasing the efficiency of the process overall.”

Sanguine is able to meet, review disclosures and collect blood samples in a patient’s home with its own phlebotomists in multiple major U.S. cities. Patients are also able to track how their de-identified biospecimen and data are used through the donor web portal. The company is able to collect and process blood from patients with any disease and has already built large libraries in multiple chronic and severe conditions, including Huntington’s disease, rheumatoid arthritis, systemic lupus erythematosus, Crohn’s disease, ulcerative colitis and others.

In order to maintain appropriate confidentiality, all samples are de-identified immediately upon collection. Sanguine maintains and reviews internal ethical guidelines for the procedures under high scrutiny from an independent review board.

Source: PR Newswire