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Archives for June 2013

Pathway Genomics to Launch Next-Generation Sequencing (NGS) Comprehensive Cancer Panel Including BRCA1 and BRCA2

Pathway Genomics, a genetic testing laboratory on the forefront of bringing physicians a broad genetic testing portfolio covering a wide range of diseases, announces the pending launch of its inherited cancer panel with BRCA1 and BRCA2.

Pathway Genomics’ Hereditary Cancer DNA Insight test utilizes next-generation sequencing (NGS) technology and will analyze genes related to a selection of hereditary cancers including breast, ovarian, colorectal and others. The company notes that it intends to introduce all their cancer panels in August 2013.

“I am delighted to see laboratories like Pathway offering genetic tests for inherited cancers,” said Linda Wasserman, M.D., Ph.D., former Director of the Clinical Cancer Genetics Care Unit at Moores UCSD Cancer Center. “Next-generation sequencing is a critical step in making actionable genetic information more accessible to the physician, ultimately benefitting the patient.”

Inherited BRCA gene mutations are responsible for approximately five percent of breast cancers and about 10-15% of ovarian cancers. Patients who have deleterious BRCA mutations may also have increased risk of other cancers.

Jim Plante, President and CEO of Pathway said, “Pathway is committed to innovation in health care and to improving the health of millions of patients with increased risk of developing cancer. We believe Pathway Genomics’ Hereditary Cancer DNA Insight is an important test in our genetic portfolio and it will enable the medical community to progress towards more personalized health care at an affordable price.”

Pathway Genomics’ genetic tests screen patient DNA using advanced technologies to provide scientifically-validated and actionable information for a wide range of genetic and inherited diseases including recessive diseases, traits that impact heart health, drug response and nutrition.

Source: Pathway Genomics

Regional Cancer Care Associates (RCCA) and GenPath Oncology Announce Diagnostic Laboratory Partnership to Benefit Nearly a Quarter Million NJ Cancer Patients

Regional Cancer Care Associates LLC (RCCA), one of the nation’s largest oncology physician groups, announced today it has partnered with GenPath Oncology (www.genpath.com), a business unit of BioReference Laboratories to bring advanced diagnostics to the practice’s more than 230,000 cancer patients.

RCCA and GenPath have joined together to create an advanced molecular laboratory on the grounds of the John Theurer Cancer Center in Hackensack, NJ. This initiative expands the group’s offered services into key diagnostic testing for their patient community. The first step in this multi-year partnership is the development of a physician-owned immunophenotyping service for hematological malignancies. In addition, GenPath will also be providing a significant amount of esoteric diagnostic testing to RCCA’s network of 92 oncology physicians in 27 locations.

The partnership with GenPath will strengthen RCCA’s mission to raise the standard of cancer care across the state, while remaining competitive in a changing healthcare environment where medical practices increasingly face declining reimbursements and rising administrative costs.
“We recognize that providers are forming larger practices to meet the challenges of a changing market. BioReference continues to adapt as our clients evolve. RCCA and BioReference both share a commitment to patient care and support scientific innovation for this purpose,” said Marc D. Grodman, M.D., President and CEO of BioReference Laboratories.

“RCCA was established to offer the highest quality and most comprehensive cancer care and our partnership with BioReference expands upon that goal. Through this relationship, RCCA is well positioned to offer the most innovative cancer diagnostics,” said Edward J. Licitra, M.D., Ph.D. and Board Chairman of RCCA.

RCCA is one of the nation’s largest oncology physician networks. As a group, RCCA is transforming healthcare, by providing a broad range of quality cancer services to patients while also controlling the cost of patient care through practice-management consistency, more competitive contractual rates and hospital privileges, resulting in long-term savings for payers. The new RCCA testing service, scheduled to begin in June, will focus on providing timely and clinically-relevant results for patient care in a cost effective manner.
According to Licitra, oncology is at a crossroads—increasing longevity in the population has the unintended effect of raising the incidence of cancer. “Oncology care is advancing, becoming more specialized and therefore getting more expensive. Over time, some cancer care may become unaffordable, and that would be tragic. We need to take steps now that allow us to modulate the growth of the cost of cancer care while maintaining quality,” he explained.

GenPath, headquartered in Elmwood Park, was selected from among the largest cancer laboratories in the nation, due to its scientific expertise and longstanding relationships with many of RCCA’s physicians. GenPath offers oncology providers a single source for cancer patient management, including bone marrow morphology, solid tumor diagnosis, molecular genetics for personalized medicine, and even routine clinical testing specific for cancer patients. In addition, GenPath offers two innovative proprietary testing modalities, OnkoMatch, a tumor genotyping test that covers more than 100 possible mutations in 14 clinically targetable oncogenes, and GenArray which scans a patient’s entire genome for chromosomal abnormalities, offering superior coverage over conventional methods such as FISH and cytogenetics.

Source: PR Newswire

Development of New Technologies Spurs Molecular Diagnostic Test Volumes in Asia-Pacific, Finds Frost & Sullivan

The Asia-Pacific molecular diagnostics market is poised for rapid growth owing to the high prevalence of diseases, increase in the aged population, economic development, and the rising need for better healthcare services. Although several challenges related to cost, regulations and reimbursement policies exist, the market offers immense opportunities for molecular diagnostics vendors.

New analysis from Frost & Sullivan (http://www.lifesciences.frost.com), Analysis of the Asia-Pacific Molecular Diagnostics Market, finds that the market earned revenues of more than US$846.5 million in 2012 and estimates this to reach US$2,528.1 million in 2019.

Public awareness on new, cutting-edge technologies and preventive medicine is increasing in several Asia-Pacific countries. Recognition that molecular diagnostics tests are more accurate, cost-effective, and short turnaround time compare to conventional diagnostics has spurred market growth.

“Newer, automated technologies such as microarrays, Real time PCR technology, mass spectrometric proteomic analyses and protein chips have transformed the way physicians detect and diagnose cancers and genetic diseases at an early stage,” said Frost & Sullivan Healthcare Industry Analyst Gulifeiya Abuduxike. “This has also paved the way for personalized medicine, which can identify the predisposition of a patient to a disease based on genetic variants, and target therapy at the right time.”

While these advanced, automated and integrated technologies widen the application scope of molecular diagnostics, they also lead to high test costs, which a huge section of patients in Asia-Pacific are unable to afford.

The lack of healthcare insurance and reimbursement schemes for diagnostics, usually not considered as important as drugs, further limits adoption in the region. The shortage of skilled technicians and insufficient infrastructure adds to the challenge.

Therefore, clinicians and patients must be educated on the medical value and benefit of molecular diagnostics as well as the need for early detection and preventive medicine. Governments need to establish reimbursements for molecular tests to boost test volumes as well as to reduce the treatment costs.

“Expanding testing menus and application areas, as well as developing automated instruments through research and development are also crucial,” noted Gulifeiya. “Molecular diagnostic companies must look to enhance the accuracy of test results and reduce time consumption.”

As focus shifts to oncology testing, pharmacogenomics and the co-development of companion diagnostics will be key business strategies for Asia-Pacific pharmaceutical companies to maximize the cost-effectiveness of cancer drugs.

If you are interested in more information on this research, please send an e-mail to Donna Jeremiah, Corporate Communications, at djeremiah@frost.com, with your full name, company name, job title, telephone number, company e-mail address, company website, city, state and country.

Analysis of the Asia-Pacific Molecular Diagnostics Market is part of the Life Sciences Growth Partnership Service program. All research services included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.

Source: Frost & Sullivan

Rosetta Genomics Announces Acceptance for Publication by Molecular Cancer of Rosetta Cancer Origin Test Manuscript

Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that a manuscript reporting data validating the clinical utility of the Rosetta Cancer Origin Test™ (formerly miRview® mets2) to identify the tumor of origin in Cancer of Unknown or Uncertain Primary (CUP) has been accepted for publication in the peer-reviewed on-line journal Molecular Cancer. The article, titled “Novel microRNA-based assay demonstrates 92% agreement with diagnosis based on clinicopathologic and management data in a cohort of patients with carcinoma of unknown primary,” represents the seventh peer-reviewed publication relating to our CUP assays, and the fifth peer-reviewed publication relating to post market validation studies demonstrating the Cancer Origin Test’s ability to identify tumor origin in CUP with 92% concordance, the highest level of accuracy of any similar study published to date.

The manuscript discusses the performance of the Cancer Origin Test, an assay utilizing 64 microRNAs to identify 42 tumor types, in formalin-fixed paraffin-embedded (FFPE) samples from 84 CUP patients The results showed concordance with the final diagnosis in 92% of patients; representing an improvement in agreement of 22 percentage points from presentation diagnosis to final diagnosis, which final diagnosis was achieved after more precise clinical and pathological data was added to the data relied upon for the patient’s initial assessment.

“MicroRNAs are particularly well-suited as biomarkers for identifying tumor origin as their expression levels and profile reflects tissue origin. Importantly, microRNAs have been shown to be highly stable in tissue blocks, the most common and readily available specimen type in pathology. Profiling microRNA from FFPE tissue has been described to be superior to mRNA profiling, since the latter are prone to extensive degradation in FFPE samples,” stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. “These data are important as they continue to confirm the clinical utility and extremely high level of concordance with the final diagnosis in real-world CUP patients. The availability and accuracy of our Cancer Origin Test underscores why the uncertainty of CUP is no longer acceptable.”

According to E. Robert Wassman, MD, FAAP, FACMG, Rosetta Genomics’ Chief Medical Officer, “CUP presents clinicians with a diagnostic as well as a management challenge. The identification of tumor origin in metastatic patients is crucial for planning patient management and care, since many oncology treatments include cancer-specific therapies. Moreover, these specific therapies and related targeted therapies have been shown to lead to increased survival of patients with advanced cancers of known origin. Consequently, it is not a matter of whether to use microRNA profiling, but when to use it.”

Source: PR Newswire

Article Highlights the Value of PreDx Testing of Prediabetic Patients in the Primary Care Setting

An article published in Clinical Diabetes describes the clinical value of PreDx testing for more effective management of prediabetes patients in the primary care practice setting. The PreDx test is a predictive multi-biomarker fasting blood test developed by Tethys Bioscience, Inc., that stratifies adult patients with prediabetes into low, moderate or high risk categories for developing type 2 diabetes within 5 years. In addition to enabling the more cost‐efficient allocation of healthcare resources toward those prediabetes patients at highest risk of progression, PreDx has also been shown to be an effective tool for monitoring the impact of lifestyle interventions in reducing the likelihood of developing the disease.

Authored by primary care practitioners Paul Rich, MD and Charles Shaefer, MD, endocrinologist Steven Edelman, MD, and Chris G. Parkin, MS, the article discusses how PreDx testing helps health care providers overcome two important obstacles that hinder more effective diabetes prevention efforts in the primary care setting – the inability of current assessment tools to differentiate prediabetes patients based on risk of progression, and the constraints on physician time and resources. A review of published literature regarding the clinical validity of PreDx for the risk-based stratification of prediabetes patients and the monitoring of their response to interventions is accompanied by case studies that illustrate the authors’ experiences with the test in their practices, and concludes with a four-step process to help clinicians effectively integrate the PreDx test into their prediabetes management protocols.

The authors summarized their experiences with PreDx testing as follows:

Paul Rich, MD: “Our experience with PreDx testing has illustrated its value as a practical means to achieve greater success in diabetes prevention at the primary care level. Unlike other lab tests that give us more numbers to consider, PreDx interprets those results for us, generating a predictive score that identifies our most vulnerable prediabetes patients, and helps guide our management strategies for those patients. That saves us time, optimizes how we use our resources, and gives our patients a better chance of avoiding a very bad disease. No other test does that.”

Charles Shaefer, MD: “The insights we get with PreDx, in terms of who to treat more intensively and how well they’re responding to those interventions, have enabled us to make more-informed treatment decisions that produce better outcomes, as demonstrated by the results achieved in our case studies.”

Steven Edelman, MD: “An added advantage of PreDx is the motivational impact their score has on patients who have resisted dealing with their diabetes risk despite previous warnings. Somehow, a personalized numerical score, that presents their risk on a scale of 1 to 10, gets through to them, and prompts them to take action to lower their risk by making healthier lifestyle choices.”

Juan Frias, MD, Chief Medical Officer for Tethys Bioscience and a practicing endocrinologist, commented on how the review article could help enhance the use of the PreDx test, especially given the recent launch of a fingerstick option for blood collection. “PreDx is a valuable clinical tool that, until recently, has only been accessible to practices with in-practice phlebotomy capabilities. The flexibility to perform the test with either venous or capillary blood means that many more practices will be able to offer PreDx to their prediabetes patients, and benefit from the unique clinical utilities it offers.”

Study: Using a Quantitative Measure of Diabetes Risk in Clinical Practice to Target and Maximize Diabetes Prevention Interventions

Source: PR Newswire