Quantcast

Industry news that matters to you.  Learn more

Study Expands Use of Biomarker for Early Diagnosis of Acute Kidney Injury

A biomarker test developed initially to identify early acute kidney injury (AKI) after surgery has been shown to successfully detect AKI in emergency room patients with a variety of urgent health issues.

In a study published online Sept. 5 in the Clinical Journal of the American Society of Nephrology, the findings expand the overall utility and potential medical settings for using the test, according to researchers.

The test measures the protein neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker of early AKI. It was invented by researchers at Cincinnati Children’s Hospital Medical Center to detect AKI earlier than existing methods, and to more promptly begin treatment.

“The majority of our studies on NGAL have been performed in well controlled settings of hospital-acquired AKI, such as cardiac surgery, contrast administration or other critically ill patients,” said Prasad Devarajan, MD, senior author and director of Nephrology and Hypertension at Cincinnati Children’s. “The purpose of this study was to determine the biomarker’s accuracy in a diverse group of patients admitted from the emergency department, where patients with early signs of AKI are often misdiagnosed.”

The study involved patients admitted through the emergency room of Fernando Fonseca Hospital in Portugal, which also closely collaborated on the study. The findings demonstrate the NGAL test, which uses a single drop of blood and provides results within 15 minutes, was able to accurately distinguish AKI from reversible transient kidney dysfunction.

Of 616 patients who participated in the study, individuals who were subsequently diagnosed with true AKI had the highest levels of NGAL detected at the time of hospital admission. The study also identified a cutoff point in NGAL levels above which the risk of acute kidney injury increases tenfold.

Results of a study previously published in 2008 by Devarajan showed that the NGAL test predicted AKI in pediatric heart surgery patients within hours instead of days, allowing treatment that prevented serious damage to kidneys. Prior to the NGAL test, serum creatinine was the only reliable method for detecting kidney damage; however, the long wait for results often resulted in permanent kidney damage.

With a growing number of patients coming to emergency rooms with community-acquired AKI, Devarajan says having a rapid, reliable method of detecting kidney injury is increasingly important.

“This latest study showed that this simple laboratory test provides an accurate prediction of acute kidney injury and its severity in a diverse clinical setting,” said Devarajan. “The identification of biomarkers that differentiate intrinsic AKI from transient reversible forms of renal dysfunction and predict outcomes is a high priority.”

Study: Plasma NGAL for the Diagnosis of AKI in Patients Admitted from the Emergency Department Setting [Clinical Journal of the American Society of Nephrology]

Source: EurekAlert!

Study Identifies Fibroblast Growth Factor 18 as an Ovarian Cancer Biomarker

Ovarian cancer is one of the leading causes of cancer-related death in women and is often not detected until the later stages of disease, which contributes to poor prognosis. Biomarkers that can be used for early diagnosis and outcome have been identified; however, many of these have not been evaluated at the biological and clinical levels. In the current issue of the Journal of Clinical Investigation, Michael Birrer and colleagues at Massachusetts General Hospital identify fibroblast growth factor 18 (FGF18) as a predictive marker for poor overall survival in ovarian cancer patients. Overexpression of the gene encoding FGF18 was associated with enhanced tumor blood vessel formation and expression of cancer promoting cytokines. These data indicate that further studies on the predictive potential FGF18 and its use as a therapeutic target in ovarian cancer are warranted.

Study: FGF18 as a prognostic and therapeutic biomarker in ovarian cancer [The Journal of Clinical Investigation]

Source: EurekAlert!

Researchers to Identify Genetic Biomarkers for Aggressive Breast Cancer

The Avon Foundation for Women recently awarded a $300,000 grant to Dolores Di Vizio, MD, PhD, associate professor in the Department of Surgery and the Department of Pathology and Laboratory Medicine and a member of the Cancer Biology and Urologic Oncology Research Programs at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute to advance scientific research in aggressive breast cancer.

Di Vizio will collaborate with the Cedars-Sinai Women’s Cancer Program to investigate biomarkers in patient blood samples that may identify individuals with aggressive breast cancer. Biomarkers are genes or other molecules that can indicate a person’s predisposition to specific medical conditions.

Research findings have the potential to create a novel standard of care and a new source of biomarkers. The possible new source of biomarkers, known as large oncosomes, are tumor-derived vesicles that transmit signaling complexes between cell compartments, providing valuable insight into the progression of disease. Findings may also help researchers and clinicians predict the aggressiveness of breast cancer earlier in the diagnostic process.

“This kind of research is the essential foundation to get us to our real goal, which is to improve diagnostic and prognostic capabilities and find effective treatments for breast cancer,” said Di Vizio. “With this study, we hope to identify previously unrecognized large oncosomes as potential biomarkers in advanced tumors that can be visualized, quantified and isolated using methods easily translatable to the clinic.”

Funding from the Avon Foundation for Women, a nonprofit organization and longtime supporter of Cedars-Sinai, will provide an opportunity for researchers to further spearhead new technologies, therapies and surgical interventions that may provide better patient outcomes, beginning at diagnosis.

Working with Di Vizio to provide these advancements is collaborator Beth Y. Karlan, MD, director of the Women’s Cancer Program, director of the Division of Gynecologic Oncology in the Department of Obstetrics and Gynecology, the Cedars-Sinai Board of Governors Chair in Gynecologic Oncology and the director of the Cedars-Sinai Gilda Radner Hereditary Cancer Program.

“I’m excited to be a collaborator on this research study, as it holds promise to provide tangible improvements in earlier diagnostics and detection in aggressive breast cancer and is perfectly aligned with the program goals of the Cedars-Sinai Women’s Cancer Program,” said Karlan. “This Avon Foundation for Women grant will further our program’s commitment to studying cancer biology, developing new approaches to early detection and preventing and improving cancer survival for all patients.”

This is the first study on large oncosomes analyses in patients with breast cancer. Pilot funding for this grant is supported by the Martz Breast Cancer Discovery Fund.

Source: EurekAlert!

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

Researchers Develop Specific Tests to Identify Cancer Biomarkers in Dermatomyositis

Researchers from major universities in the U.S. have developed specific tests to identify cancer biomarkers in patients with dermatomyositis—a systemic inflammatory disease associated with increased risk of malignancy. According to study findings published in the American College of Rheumatology (ACR) journal, Arthritis & Rheumatism, the assays detect antibodies against anti-transcriptional intermediary factor-1 (TIF-1γ) and nuclear matrix protein NXP-2.

Patients with dermatomyositis experience muscle weakness, skin inflammation, and sometimes inflammation of the lung. Most patients with dermatomyositis have auto-antibodies circulating in their bodies that cause distinct clinical disease features. Medical evidence suggests that these auto-antibodies in dermatomyositis patients stem from specific immune responses that shape various characteristics (phenotypes). In addition, up to 20% of those with dermatomyositis are at increased risk of malignancies.

“For the physician treating patients with dermatomyositis, identifying those at higher risk for cancer is a top priority,” explains Dr. David Fiorentino from Stanford University in Redwood City, Cal. “Our team focused on creating specific tests to detect antibodies against two specific proteins and then testing if those antibodies can identify dermatomyositis patients at higher risk of cancer.”

The team used both immunoblotting and immunoprecipitation techniques to detect antibodies against TIF-1γ and NXP-2 proteins. Blood analysis was performed on 111 patients from Stanford University Dermatology Clinic and 102 patients from the Johns Hopkins University (JHU) Myositis Center. Both groups were similar in gender and age at diagnosis.

Results show that 17% and 38% of subjects in the two cohorts combined had antibodies against NXP-2 and TIF-1γ, respectively. Using the specific assays, researchers found 83% of dermatomyositis patients with cancer had a reaction to NXP-2 or TIF-1γ. Further analysis indicates that cancer, older age, and male gender were linked to NXP-2 or TIF-1γ antibodies, with anti-NXP-2 specifically associated with cancer in men.

“Our findings confirm the link between cancer and age in dermatomyositis, with a sharp increase in frequency at roughly 60 years of age.” concludes Dr. Fiorentino. “By determining the presence or absence of NXP-2 and TIF-1γ antibodies, we believe that this will aid clinicians in identifying those with the highest cancer risk.”

Study: Most patients with cancer-associated dermatomyositis have antibodies to nuclear matrix protein NXP-2 or transcription intermediary factor 1-gamma [Arthritis & Rheumatism]

Source: EurekAlert!