Quantcast

Industry news that matters to you.  Learn more

Critical Diagnostics Launches a Rapid Point-of-care Test for its Cardiac Biomarker ST2

At Critical Diagnostics’ annual European Distributor-Partners Meeting held in Rome last month, the company unveiled its Aspect-LF™ ST2 test, a point-of-care version of the company’s lab-based Presage® ST2 Assay. Aspect-LF will be made available throughout Europe and select Asia-Pacific countries later this year.

Mount Sinai Launches First-ever Genetic Testing Program in the Primary Care Setting

The Icahn School of Medicine at Mount Sinai is partnering with the Institute for Family Health to launch the first-ever genetic testing program in the primary care setting to identify genetic risk for kidney disease in patients with hypertension.

The program will be funded through a $3.7 million grant from the National Human Genome Research Institute of the National Institutes of Health. Primary-care providers will use patients’ genomic information at the point-of-care to individualize treatment, testing and monitoring with Mount Sinai’s Clinical Implementation of Personalized Medicine through Electronic Health Records and Genomic Program, or CLIPMERGE, a novel clinical-decision support engine for delivering guidelines with genetic variants of clinical significance to enhance treatment.

Recent research has shown that one in eight African Americans have two copies of a version of the APOL1 gene, putting them at four to five times greater risk for developing chronic kidney disease or end-stage kidney disease if they have hypertension, or high blood pressure.

“Many patients do not have their blood pressure adequately controlled,” said Erwin Bottinger, MD, Director of the Charles Bronfman Institute for Personalized Medicine at the Icahn School of Medicine at Mount Sinai, and one of two principal investigators of the grant. “We believe that with genomic information made available to doctors through a patient’s electronic health record, we will be able to achieve better and stricter control of blood pressure and targeted use of medications that inhibit the renin angiotensin system, which are recommended in hypertensive patients at risk for kidney disease. More comprehensive tracking will also help ensure that optimal tests will be performed to stop progression of kidney disease.”

A cluster-randomized controlled trial will be conducted at 12 primary care sites in New York, including practices at The Mount Sinai Medical Center and the Institute for Family Health, which operates an independent network of community health centers in Manhattan and the Bronx.

“Genes are another piece of the puzzle that may help explain why people of African descent have poorer health outcomes than people of European descent,” said Carol Horowitz, MD, MPH, co-principal investigator and co-director of the Icahn School of Medicine at Mount Sinai’s new Center for Health Equity and Community Engaged Research. “We look forward to engaging with and helping educate our multicultural community partners, providers, and patients about the emerging role genetic testing will play in improving health.”

Neil Calman, MD, President and Chief Executive Officer of the Institute for Family Health, and Professor and Chair of Family Medicine and Community Health at Mount Sinai said, “Community-based primary care physicians have had little opportunity to incorporate genomics into the care of patients, and this grant offers us a tremendous opportunity. We hope to screen patients, identify those with increased genetic risk and work with them to prevent kidney disease. We will also train community-based primary care providers in how to discuss genetic risk with patients and their families and how to use genetic-based information in the electronic health record.”

Source: EurekAlert!

ApoCell Announces Delivery of First Prototypes of ApoStream Circulating Tumor Cell (CTC) Isolation Technology to National Cancer Institute

ApoCell, Inc. recently announced that the first prototypes of its ApoStream™ circulating tumor cell (CTC) isolation system have been delivered to select investigator sites including SAIC-Frederick Inc. (SAIC-F) in support of the National Cancer Institute (NCI). The delivery is part of a $2.9 million subcontract awarded to ApoCell in Q1-2011 by SAIC-F to develop a device capable of isolating live cancer cells from small volumes of blood. While ApoStream™ has been used in ApoCell’s laboratories since 2010; this first external placement of the technology is a significant milestone in the company’s plan to commercially offer the device as a vital tool in the development of targeted therapies for the prevention and treatment of cancer.

“The NCI research environment has provided an ideal first external placement for ApoStream™ and the performance of the device to date has been consistent with our own findings,” said Darren Davis , ApoCell president and CEO, adding that results were presented at the Molecular Medicine Triconference on February 15, 2013. ApoCell has shipped four ApoStream™ prototypes to NCI and will deliver a total of 12 by year end, Davis said.

ApoCell has incorporated ApoStream™ into a number of ongoing early and late stage clinical trials as part of the company’s service offering. The recent external placement of ApoStream™ prototypes enables the company to begin its beta-testing program for third party validation of the technology. ApoCell is now looking to place ApoStream™ prototypes at additional investigator sites around the world as part of the beta testing phase. The company plans to commercially launch the technology for research-use-only in 2014.

CTCs have long been known to exist in cancer patients’ blood and clinical correlations have been established between CTC counts and disease progression. These circulating cells represent an attractive target for clinicians seeking to assess a patient’s disease state; however the clinical promise of using CTCs to select appropriate treatments and monitor effectiveness has yet to be fully realized. One reason is that CTCs are extremely rare and difficult to isolate using the commercially available technologies, many of which rely on antibodies that attach to specific cancer cell antigens such as EpCAM.

ApoStream™ is antibody independent and utilizes a process known as dielectrophoresis (DEP) field-flow assist. The technology employs a non-uniform electrical field at specific frequencies to separate viable cancer cells from normal blood cells by relying on a cancer cell’s unique form and structure rather than surface antigen expression. ApoStream™ has been shown to detect significant quantities of intact CTCs from a wide range of cancer types, enabling more robust downstream analysis for greater understanding of each patient’s disease.

After the commercial launch of the research-use-only instrument, Davis said ApoCell plans to continue developing ApoStream™ technology for a clinical point-of-care device that would provide oncologists with more effective monitoring of targeted therapies for various cancer types. The company’s goal is to launch a clinical instrument in 2016.

“We believe ApoStream can play a significant role in the evolution of personalized cancer treatment,” Davis said.

Source: PR Newswire

New Study Proves Univfy IVF Prediction Tests More Accurate in Predicting IVF Success

Univfy Inc., a pioneer in predictive technology for health care and fertility, recently announced the publication of new research findings in Fertility & Sterility, validating the company’s Univfy PreIVF prediction tests as 1,000-times (likelihood scale) more powerful in predicting the probability of live birth in the first in vitro fertilization (IVF) treatment compared to estimates based on a woman’s age.

The peer-reviewed paper, “Personalized Prediction of First-Cycle In Vitro Fertilization Success,” shows that 86 percent of cases analyzed had significantly different probabilities of success compared to age-based estimates, and nearly 60 percent had a higher probability of live birth based on an analysis of the patients’ complete reproductive profiles. In fact, using the Univfy PreIVF prediction model, 42 percent of patients were found to have a personalized predicted success rate greater than 45 percent, while the age-control model could not differentiate these patients from others in the population.

Proven Accuracy Based on Personalized Prediction

The study is the first to validate that patient data available prior to starting IVF can be used to predict a patient’s chance of success to help her decide whether to pursue a first IVF treatment. The Univfy PreIVF test is an online data test that analyzes each individual’s fertility profile (including age, Body Mass Index (BMI), Day 3 FSH, semen analysis, and prior fertility and medical history) and compares it against data from thousands of IVF cycles to instantly deliver personalized prognosis of IVF success. The retrospective validation study analyzed anonymized IVF data aggregated from more than 13,000 first IVF cycles from three university-affiliated outpatient IVF clinics in the U.S., Canada and Spain.

Personalized Prediction of IVF Success Helps Patients

“Our research findings allow us to use known clinical predictors with much greater predictive power to support patients who are considering IVF for the first time,” said Mylene Yao, M.D., CEO and co-founder of Univfy. “Not knowing their personal chances of IVF success may cause many women to be missing out on a treatment that could be highly effective for them.”

While a higher likelihood of success is welcome news for many couples, the study also suggests predictions based on age alone, or age plus a few factors, could falsely reassure a small percentage of patients. Based on the predicted probability, the Univfy PreIVF test also reports the percentile of a patient’s chances of success, which provides a more balanced perspective to the patient and her doctor.

“An accurate prognosis is equally important for those whose likelihood of success is quite high and for those whose chances are much lower than age-based predictions,” Dr. James Grifo, Program Director of the New York University Fertility Center and Director of the Division of Reproductive Endocrinology and Professor of Obstetrics and Gynecology at the NYU School of Medicine. “Predicting the chances of IVF success for each patient may also support physicians in refining clinical protocols to improve care.”

“More accurate personalized prognoses of potential live birth outcomes with IVF can guide both patients and their physicians with treatment decisions,” said Dr. Gedis Grudzinskas, Consultant in Infertility and Gynaecology at 92 Harley Street, London Bridge Hospital, Princess Grace Hospital and Woodlands Health Centre, London, UK, and Editor of Reproductive Biomedicine Online, an international journal devoted to biomedical research on human reproduction.

Enhancing Care through Predictive Analytics

Previously, advanced predictive modeling that is rigorously validated was not accessible to patients and the broader medical community. Univfy has integrated these research processes with proprietary, analytics-powered platforms to deliver scientifically validated predictive information via a user-friendly interface to patients and providers. The Univfy platforms can also serve point-of-care prognostics or administrative needs in other areas of healthcare, outside of reproductive medicine.

Univfy offers complimentary and confidential analysis to any clinic interested in learning how closely their patient-specific success rates compare to the Univfy PreIVF model. This analysis is feasible even for small or mid-size fertility clinics.

Based on its proven model, Univfy offers two prediction tests for consumers: the Univfy PreIVF for women considering IVF for the first time, and the Univfy PredictIVF for women who have had IVF and are considering another IVF treatment. Both are online tests that patients complete in the privacy of their own home by simply entering their own individual health data. The tests are also available for use in physician offices via Univfy’s clinic platform through a business-to-business model. Semi-customization of prediction tests is also available upon request.

Study: Personalized prediction of first-cycle in vitro fertilization success

Source: Univfy

CollabRx Forms Pan Cancer Molecular Oncology Editorial Board

CollabRx, Inc. (NASDAQ: CLRX), a data analytics company focused on informing clinical decision making in molecular medicine, recently announced the formation of a Pan Cancer (biomarker-focused) molecular oncology editorial board to be led by Razelle Kurzrock, M.D., who will serve as Chief Editor.

Dr. Kurzrock is Director of the Center for Personalized Therapy at UC San Diego Moores Cancer Center, Vice Chief of the Hematology-Oncology Division in the UC San Diego School of Medicine and Senior Deputy Center Director, Clinical Science, for UC San Diego Moores Cancer Center. Previously, Dr. Kurzrock developed one of the largest Phase 1 clinical trials programs in the nation at the MD Anderson Cancer Center. A central theme of that program was a personalized medicine strategy that utilized advanced molecular technologies to match patients with targeted cancer treatments that optimized chances for response.

Dr. Kurzrock leads a distinguished group of physicians from UC San Diego, MD Anderson Cancer Center, and other institutions both in the US and abroad. Background about the complete editorial board can be found on the company’s website (http://www.collabrx.com/expert-affiliations/cancer-specific-editorial-boards/pan-cancer/).

The newly formed Pan Cancer board is the most recent addition among CollabRx’s existing editorial boards, which identify clinically actionable biomarkers in the context of individual cancer types such as lung cancer or melanoma. The Pan Cancer editorial board is differentiated in that it will apply a broad molecular oncology perspective in the identification of biomarkers that are clinically actionable in any cancer type. Both types of editorial boards link biomarkers to therapy considerations including drugs and clinical trials. This complementary approach supports the emerging view in personalized oncology that cancers are defined not just by their tissue of origin (e.g., lung cancer), but also by the molecular aberrations they harbor (e.g., EGFR mutations) that can be targeted by specific drugs or combinations of drugs (e.g., EGFR inhibitors).

“It is with great pleasure and anticipation that I assume my new role as Chief Editor of the Pan Cancer editorial board,” said Dr. Kurzrock. “I look forward to working with my board and CollabRx staff to provide our physician colleagues with a high-level understanding of how tumor genetics are being leveraged in therapy development and to develop a best-in-class online educational resource for understanding how to use tumor genetic profiles to inform treatment planning for cancer patients.”

The Pan Cancer board’s initial activities will focus on the development of a Web-based application that will associate specific biomarkers with expert-vetted and clinically relevant information on drugs and clinical trials. The application functionality will be extended in stages and at launch will address sequencing-based biomarkers such as gene mutations, insertions/deletions, fusions and other aberrations. CollabRx will make a version of this application freely available online for physicians and researchers to learn about clinically actionable biomarkers in any cancer type. Subsequently, pathologists and oncologists will be able to use the application at the point of care to annotate their own data generated on any next-generation sequencing platform or sequencing-based test results obtained from any laboratory.

“The formation of a Pan Cancer editorial board illustrates our company’s strategy of developing products and services for pathologists and laboratories, and it represents a significant step forward in our commitment to provide a best-in-class, expert-vetted interpretation to next-generation clinical cancer sequencing panels,” said Thomas Mika, Chairman, President & Chief Executive Officer of CollabRx. “We are honored that Dr. Kurzrock and her board members are joining our large and growing expert advisory network and are working with us to assist physicians in matching patients to targeted agents based on actionable genetic aberrations.”

Source: CollabRx