Author Interviews, Biomarkers, Technology / 06.10.2023

MedicalResearch.com Interview with: HUANYU “LARRY” CHENG Ph.D. Associate Professor and Dorothy Quiggle Career Development Professor in Engineering James L. Henderson, Jr. Memorial Associate Professor of Engineering Science and Mechanics Penn State University MedicalResearch.com: What is the background for this study? Response: Although increasing efforts have been devoted to the development of non-invasive wearable electrochemical sweat sensors for monitoring physiological and metabolic information, most of them still suffer from poor stability and specificity over time and fluctuating pH and temperatures. laser-induced graphene is the low-cost platform for the early identification and continuous monitoring of different biomarkers for non-invasive disease diagnosis and treatment evaluation However, low sensitivity and limited surface area can limit the detection of ultra-low biomarker concentration in sweat or other fluids. As a result, a wide range of conductive nanomaterials has been incorporated into the porous structure of LIG to increase the available surface area, facilitate electron transfer, and enhance the electrocatalytic activity of the electrode but those nanomaterial modifications are hard to manufacture reproducibly, and they are not long-term stable. Therefore, it is highly desirable to develop a highly sensitive, selective, low-cost, and long-term stable flexible sensing platform for continuous and accurate healthcare monitoring. (more…)
Author Interviews, Biomarkers, Infections, Inflammation, Pediatrics / 18.08.2023

MedicalResearch.com Interview with: Myrsini Kaforou, PhD Senior Lecturer in Bioinformatics Department of Infectious Disease Imperial College London MedicalResearch.com: What is the background for this study? Response:  Children very often present to hospital and clinics with fever, but fever is a non-specific disease symptom. The identification of the cause of fever poses a great challenge for the clinical teams worldwide. The available diagnostic tests are neither quick or accurate enough to fully base decisions on, such as withholding or administering antibiotics. For example, cultures may take days or even weeks to provide a result. In our research group, we are working on novel approach; instead of trying to identify the causative pathogen, which is often inaccurate or impossible, we are studying the genes in the patient's blood that are "switched on" or "switched off" during the infection or the disease in general. Using computational/bioinformatics methods, we are able to identify out of thousands of genes, the combinations of genes, "the biosignatures" for each disease. In the past we had shown that this approach works to distinguish bacterial from viral infection, or tuberculosis disease from other conditions that mimic its symptoms. But with this work we have shown for the first time that a single set of genes, a "single gene panel" can be used to discriminate between 6 broad and/or 18 specific infectious or inflammatory conditions that cause fever in children. (more…)
Author Interviews, Biomarkers, Gastrointestinal Disease / 16.08.2023

MedicalResearch.com Interview with: Daniel L. Worthley MBBS (Hons), PhD, MPH, FRACP, AGAF Gastroenterologist Associate Professor University of Adelaide MedicalResearch.com: What is the background for this study? Response: Cells are revolutionising healthcare, from modern faecal microbial transplantation in the gut to CAR-T cells fighting cancers, life healing life. Some aspects of cellular care are so entrenched in medicine that they are almost overlooked for the miraculous cellular therapies that they are, such as stem cell transplantation to treat haematological malignancies and, of course, in vitro fertilization, life creating life. Modern medicine is slowly, but surely, pivoting from pills to cells. Professor Siddhartha Mukherjeee, oncologist, scientist, and author, provides a beautiful thesis of this in his book Song of the Cell and in his TED talk on the cellular revolution in medicine (https://youtu.be/qG_YmIPFO68?feature=shared). I was lucky enough to have trained with Sid as a post-doc at Columbia and this concept was really drummed into me. But, as a gastroenterologist, perhaps it was the bacterial cells, rather than the blood cells, that had most to offer in the management of bowel disorders? Around the same time, Professors Jeff Hasty, Tal Danino and Omar Din from UC San Diego had been inventing and publishing, in my opinion, the best bacterial engineering work that has ever been produced to specifically target cancer. I remember when we first reviewed their 2016 Nature paper in our lab meeting (https://www.nature.com/articles/nature18930#citeas), it was like – “We gotta meet these guys!”. Through Tal, who was by then, working at Columbia, I was introduced to Jeff and I attended his lab meeting back in 2019. That was where our project began after a lab meeting in La Jolla. Rob Cooper had presented his work on horizontal gene transfer. Everything that comes out of Jeff’s lab is both practical and reproducible but also beautiful. Beautiful in a scientific self-evident way that instantly communicates the purpose, approach and outcomes of an experiment. Rob’s presentation that day was a case-in-point. Rob was studying genes and gene transfer in bacteria (see part of Rob’s fascinating presentation here, https://youtu.be/5nBsRF-BsA8?feature=shared). Genes are the fundamental unit of heredity and gene transfer (or inheritance) the process by which genes are passed from one cell to another. Genes may be inherited vertically when one cell replicates its DNA and divides into two, now separate, cells (reproduction). Genes are the stuff, and vertical gene transfer is the process, by which you receive your mother’s laugh and your father’s eyebrows. Genes may also, however, be inherited horizontally when DNA is passed between unrelated cells, outside of parent to offspring inheritance. Horizontal gene transfer is quite common in the microbial world. Certain bacteria can salvage genes from cell-free DNA found within its environment. This sweeping up of cell-free DNA, into a cell, is called natural competence. So, competent bacteria can sample their nearby environment and, in doing so, acquire genes that may provide a selective advantage to that cell. Like cellular panning for flecks of gold in a stream. After Rob’s presentation, Jeff, Rob and I started to discuss the possibilities. If bacteria can take up DNA, and cancer is defined genetically by a change in its DNA then, theoretically, bacteria could be engineered to detect cancer. Colorectal cancer seemed a logical proof of concept as the colorectal lumen is full of microbes and, in the setting of cancer, full of tumour DNA.  When a biophysicist, a scientist and a gastroenterologist walk into a bar, after a lab meeting, this is what can happen! Professor Susi Woods and Dr Josephine Wright, superb cancer scientists from Adelaide, Australia, were quickly recruited in as essential founding members of the group. We all got to work. Australian and US grants, lots of experiments, early morning Zoom calls across the Pacific, inventing new animal models and approaches, i.e. a many year, iterative process of design-build-test-learn, that got us all to where we are now. (more…)
Author Interviews, Biomarkers, Cancer Research, Genetic Research, Ovarian Cancer / 07.08.2023

MedicalResearch.com Interview with: Pei Wang, PhD Professor, Department of Genetics and Genomic Sciences Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA Michael J. Birrer MD PhD Director, Winthrop P. Rockefeller Cancer Institute University of Arkansas for Medical Sciences Little Rock, AR 72205 Amanda G. Paulovich MD PhD Translational Science and Therapeutics Division Fred Hutchinson Cancer Center Seattle WA 98109 MedicalResearch.com: What is the background for this study? How common is serous ovarian cancer? Response: Epithelial ovarian cancer accounts for >185,000 deaths/year worldwide. The most common subtype, high-grade serous ovarian cancer (HGSOC), accounts for 60% of deaths. Despite improvements in surgical and chemotherapeutic approaches, HGSOC mortality has not changed in decades. Five-year survival remains ~30% for the majority of patients. Standard of care involves surgical debulking combined with adjuvant or neoadjuvant chemotherapy with carbo- or cisplatin in combination with a taxane. At diagnosis, HGSOC is among the most chemo-sensitive of all epithelial malignancies, with initial response rates of ~85%, presumably related to DNA repair defects. Platinum is thought primarily to drive the response rate, due to the lower single-agent response rate for taxanes. Unfortunately, 10-20% of HGSOC patients have treatment-refractory disease at diagnosis, fail to respond to initial chemotherapy, and have a dismal prognosis. The poor response to subsequent therapy and median overall survival of ~12 months for these patients has not changed in 40 years. Despite >30 years of literature studying platinum resistance in cancer, there currently is no way to distinguish refractory from sensitive HGSOCs prior to therapy. Consequently, patients with refractory disease experience the toxicity of platinum-based chemotherapy without benefit. Due to their rapid progression, they are commonly excluded from participating in clinical trials. Consequently, there is no ongoing clinical research that could identify effective therapeutic agents for these patients or provide insights into molecular mechanisms of refractory disease.  “Right now, we can’t identify drug-resistant ovarian cancer patients up front,” said co-senior author Michael Birrer, MD, PhD, who directs UAMS’ Winthrop J. Rockefeller Cancer Institute. “We find them by default: They get sick and pass away so quickly that they can’t even be put on new clinical trials.” To address this unmet clinical need, we performed proteogenomic analysis of treatment-naïve HGSOCs (chemo-sensitive and chemo-refractory) to identify molecular signatures of refractory HGSOC and to identify potential treatment targets. (more…)
Author Interviews, Biomarkers, Brigham & Women's - Harvard, Diabetes, Endocrinology / 26.06.2023

MedicalResearch.com Interview with: Dr. Bita Zahedi MD MA Endocrinologist Massachusetts General Hospital MedicalResearch.com: What is the background for this study? Response: The purpose of this study was to develop and validate a measure of dietary advanced glycation end-products (AGEs) to investigate the role of dietary AGEs in diabetic disease processes.  AGEs are a group of highly reactive compounds involved in the pathophysiology of diabetic complications, such as microvascular disease, cardiomyopathy, and possibly bone health. AGEs form through a nonenzymatic reaction between reducing sugars and free amino groups of proteins, lipids, and nucleic acids, also known as a Maillard or browning reaction. Endogenous AGE formation and accumulation is a normal part of metabolism and aging, however the process of glycation can be enhanced by hyperglycemia, hyperlipidemia, and increased oxidative stress. Additionally, AGEs can be absorbed from exogenous sources via consumption of various food items. Prior studies demonstrate that skin AGEs are predictive of Dietary AGEs (dAGEs) which are naturally present in certain uncooked foods, mainly animal-derived products, furthermore the method of food preparation can result in significant AGE formation. Considering the ubiquitous intake of dAGEs, it is possible that the consumption of exogenous AGEs contribute to AGE-induced oxidative stress, inflammation, and its subsequent detrimental sequalae. (more…)
Author Interviews, Biomarkers, Nature, Prostate Cancer, UCSF / 12.06.2023

MedicalResearch.com Interview with: Rebecca E. Graff, ScD Assistant Professor University of California, San Francisco Department of Epidemiology & Biostatistics Mission Hall: Global Health & Clinical Sciences Building San Francisco, CA 94158 MedicalResearch.com: What is the background for this study? Response: PSA screening for prostate cancer has long been controversial. While it does seem to reduce mortality attributable to prostate cancer, it also results in the diagnosis of many cancers that never otherwise would have presented symptomatically. In addition, PSA levels are affected by factors other than prostate tumors (e.g., age, prostatic inflammation, and genetics), such that men with high PSA values are often referred for biopsy but do not end up having cancer. We hypothesized that accounting for the genetic component of PSA could yield adjusted values that better distinguish who should get a prostate biopsy. (more…)
Alzheimer's - Dementia, Author Interviews, Biomarkers, University of Pittsburgh / 31.05.2023

MedicalResearch.com Interview with: Bruna Bellaver PhD Postdoctoral associate Department of Psychiatry University of Pittsburgh Tharick Pascoal, MD, Ph.D. Neurologist and assistant professor of Neurology and Psychiatry University of Pittsburgh School of Medicine. MedicalResearch.com: What is the background for this study? Response: Amyloid-β (Aβ) deposition is considered one of the markers of Alzheimer’s disease pathology in the brain. The sequential order of this cascade includes the development of tau pathology and consequent cognitive decline. However, many people with Aβ deposition in the brain do not progress in the disease, suggesting that other biological processes are playing a role in these pathological events. In vitro evidence suggests that reactive astrocytes unleash Aβ effects in pathological tau phosphorylation. We found that, in cognitively healthy individuals, Aβ is associated with tau pathology only in individuals with increased astrocyte reactivity. (more…)
Alzheimer's - Dementia, Author Interviews, Biomarkers, JAMA, MRI / 22.05.2023

MedicalResearch.com Interview with: Ruben Smith MD, PhD Associate professor at Clinical Memory Research Division of Neurology Lund University   MedicalResearch.com: What is the background for this study? Response: Since a few years it has become possible to visualize tau pathology in Alzheimer’s Disease (AD) using positron emission tomography (PET). The tau-PET radiotracer Flortaucipir (Tauvid) was recently approved by the US Food and Drug Administration as an AD diagnostic tool. Since PET imaging is costly and exposes the patient to radioactivity we wanted to study the added clinical value of tau-PET in the diagnostic work-up of patients with cognitive symptoms, before widespread implementation in clinical practice. (more…)
Author Interviews, Biomarkers, Cancer Research, Genetic Research / 27.03.2023

MedicalResearch.com Interview with: Florence Le Calvez-Kelm, Ph.D. Genomic Epidemiology Branch International Agency for Research on Cancer Lyon, France and Trevor Levin Ph.D. Founder and CEO of Convergent Genomics that produces the Uroamp assay San Francisco, CA     MedicalResearch.com: What is the background for this study? Response: Bladder cancer is one of the most expensive and challenging to diagnose and treat. Therefore, identifying cost-effective urine bladder cancer biomarkers to complement or replace the gold-standard invasive and costly cystoscopy for the early detection and monitoring of this highly recurrent disease is crucial. At the international Agency for research on Cancer (IARC-WHO), we have developed a simple urine-based assay TERT promoter mutations, the most common mutations in bladder cancer, and showed that the urine biomarker could detect bladder cancer patients at diagnosis but many years prior to clinical diagnosis. However, in this study, we wanted to see whether a more comprehensive genomic profiling of urine samples collected years prior to clinical diagnosis of bladder cancer could identify even more patients before they develop any symptoms. The study was based on the UroAmp test, a general urine test that identifies mutations in 60 genes, developed by the Oregon Health Science University spin out company, Convergent Genomics. Drawing on previous research to identify genetic mutations linked to bladder cancer, the research team narrowed the new test down to focus on mutations within just ten genes. Working with colleagues from the Tehran University of Medical Sciences in Iran, they trialled the potential new test using samples from the Golestan Cohort Study, which has tracked the health of more than 50,000 participants over ten years, all of whom provided urine samples at recruitment. Forty people within the study developed bladder cancer during that decade, and the team were able to test urine samples from twenty-nine of them, along with samples from 98 other similar participants as controls. (more…)
Author Interviews, Biomarkers, Gender Differences, Kidney Disease, NEJM, Race/Ethnic Diversity / 26.01.2023

MedicalResearch.com Interview with: Prof. dr. Hans Pottel KU Leuven Kulak Department of Public Health and Primary Care Belgium MedicalResearch.com: What is the background for this study? Response:  The glomerular filtration rate (GFR) is used to diagnose patients with chronic kidney disease and is also used to adjust the dose of drugs that are eliminated by the kidneys. An accurate estimation of GFR is considered of importance in the management of kidney health in patients. In 2021 we published a new serum creatinine based equation, called the European Kidney Function Consortium (EKFC) equation (Pottel H. et al, Development and Validation of a Modified Full Age Spectrum Creatinine-Based Equation to Estimate Glomerular Filtration Rate : A Cross-sectional Analysis of Pooled Data. Ann Intern Med (2021) 174: 183-191): EKFC-eGFR = 107.3 / [Biomarker/Q]a x [0.990(Age – 40) if age > 40 years] With a = 0.322 if Biomarker/Q is less than 1, and a = 1.132 if Biomarker/Q is 1 or more. The equation can easily be interpreted: the leading coefficient equals the glomerular filtration rate (GFR) of 107.3 mL/min/1.73m², which is the average GFR in healthy children (aged > 2 years), adolescents and young adults. The average healthy GFR remains constant until the age of 40 years, and starts decreasing beyond that age. The GFR is inversely related to the ‘rescaled’ biomarker. The rescaling factor (Q) is the average biomarker value for healthy people of a specific population (e.g. children, adult men, adult women, white people, black people, …). Biomarker/Q equals ‘1’ for the average healthy person, corresponding with eGFR = 107.3 mL/min/1.73m² (up to 40 years of age). It should be noted that for serum creatinine, the Q-value depends on sex and race. Our hypothesis was that the above equation is valid for any renal biomarker, on the condition that the biomarker is appropriately scaled. We showed that the same equation was able to estimate GFR from 2 years to oldest ages. In the current study we tested and validated our hypothesis by applying the above formula for appropriately ‘rescaled’ cystatin C. (more…)
Author Interviews, Biomarkers, Heart Disease, JACC, University of Michigan / 21.12.2022

MedicalResearch.com Interview with: Salim S. Hayek MD Assistant Professor Medical Director of the Frankel Cardiovascular Center Clinics University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Essentially, immune checkpoint myocarditis is a rare but deadly complication of immune checkpoint inhibitors – amazing drugs that are increasingly used for the treatment of various cancers. Most patients present late, and when they do, they’re very ill and have a 50% chance of death. Diagnosing ICI myocarditis is challenging, given there is no one test that can differentiate it from other causes of cardiac injury. It is important to diagnose it fast, early and accurately in order to start immunosuppressive therapy as soon as possible. What we did in this study was look at commonly measured biomarkers in all patients receiving ICI at the University of Michigan. What we found was that patients who developed ICI myocarditis had early signs of muscle destruction (rise in CPK) levels and hepatitis (rise in AST, ALT), and that all patients who had myocarditis with bad outcomes had rises in all of the aforementioned biomarkers. Creatinine phosphokinase was the most sensitive. (more…)
Author Interviews, Biomarkers, JAMA, Tobacco Research / 09.11.2022

MedicalResearch.com Interview with: Dr. Hongying Daisy Dai, PhD Professor and Associate Dean of Research The College of Public Health University of Nebraska Medical Center. MedicalResearch.com: What is the background for this study? Response: Tobacco use landscape has been changing in the United States with fewer combustible cigarette smokers and more e-cigarette and other emerging tobacco users. Nicotine concentration level is a key product characteristic of modern e-cigarette products and high-nicotine vaping devices have recently become available. This study seeks to examine whether biomarkers of exposure to tobacco-related toxicants have changed since 2013 among adult nicotine e-cigarette users, non-nicotine e-cigarette users, and cigarette smokers. (more…)
Author Interviews, Biomarkers, Cancer Research, Hepatitis - Liver Disease / 18.05.2022

MedicalResearch.com Interview with: Yujin Hoshida, MD, PhD Director, Liver Tumor Translational Research Program CPRIT Scholar in Cancer Research Harold C. Simmons Comprehensive Cancer Center Professor of Internal Medicine Division of Digestive and Liver Diseases, Department of Internal Medicine University of Texas Southwestern Medical Center MedicalResearch.com:  What is the background for this study?  Response: Liver cancer is the fastest rising cause of cancer-related death in the U.S. with the sharply growing epidemic of obesity and non-alcoholic fatty liver disease. Late diagnosis at advanced stage is the main reason for the poor survival of liver cancer patients. Therefore, professional societies recommend semi-annual liver cancer screening for early diagnosis. However, it's practically infeasible due to the vast size of patient population (estimated to affect one-fourth of population). Thus, we urgently need tools to identify a small subset of patients with elevated liver cancer risk, on which we can concentrate our effort of screening. (more…)
Author Interviews, Biomarkers, Cancer Research, Colon Cancer / 18.05.2022

MedicalResearch.com Interview with: AmirAli Talasaz Ph.D. co-CEO, Guardant Health MedicalResearch.com:  What is the background for this announcement? Response: On May 2, Guardant Health announced the availability of Shield™, our first blood-based test for the detection of early-stage colorectal cancer (CRC). Colorectal cancer is the second-leading cause of cancer deaths in the U.S., so this announcement represents a tremendous public health opportunity. Here’s why: This new test will help people identify more CRC at its earliest stages, when it is most treatable. It offers an accurate, easy-to-complete, blood-based approach to CRC screening. It can be completed with a convenient blood draw during any healthcare provider visit.  (more…)
Author Interviews, Biomarkers, BMJ, Gastrointestinal Disease, Pancreatic / 09.03.2022

MedicalResearch.com Interview with: Ece Kartal, PhD Postdoctoral Fellow Saez-Rodriguez Group Universitätsklinikum Heidelberg Institute for Computational Biomedicine Heidelberg MedicalResearch.com:  What is the background for this study?    Response: Pancreatic cancer is one of the deadliest types of cancer: although incidence rates are relatively low (only few people develop pancreatic cancer in their lifetimes), it has a high lethality, with a five year survival rate of less than ~5%. Pancreatic cancer symptoms are generally unspecific so that the disease is usually detected very late which further  limits therapeutic options. In light of this, earlier detection of pancreatic cancer could dramatically improve prognosis, but there are currently no affordable and non-invasive tests available in the clinic. For pancreatic ductal adenocarcinoma (PDAC),the most common form of pancreatic cancer, it was previously found that the oral, gut and pancreatic microbiome are risk factors and may affect prognosis . (more…)
Author Interviews, Biomarkers, Heart Disease, NEJM / 03.03.2022

MedicalResearch.com Interview with: PJ Devereaux MD PhD Professor of Medicine, and of Health Research Methods, Evidence and Impact McMaster University President of the Society of Perioperative Research and Care  MedicalResearch.com:  What is the background for this study?  Response: More than 1 million patients undergo cardiac surgery in the United States and Europe annually. Although cardiac surgery has the potential to improve and prolong a patient’s quality and duration of life, it is associated with complications. Prognostically important heart injury – detected by an elevated blood concentration of either cardiac troponin or creatine kinase myocardial MB isoform (CK-MB) – is one of the most common complications after cardiac surgery and is associated with increased mortality. Although elevated CK-MB was historically used to define heart injury after cardiac surgery, this assay is no longer available in many hospitals worldwide, and consensus statements have recommended high-sensitivity cardiac troponin assays as the preferred biomarker. Based on expert opinion, the Fourth Universal Definition of Myocardial Infarction suggested that a cardiac troponin concentration >10 times the upper reference limit, in patients with a normal baseline measurement, should be the threshold used in the diagnosis of heart attack along with evidence of ischemia (e.g., ischemic ST changes on an ECG) in the first 48 hours after coronary artery bypass grafting (CABG). Although the Academic Research Consortium-2 Consensus stated there was no evidence-based threshold for cardiac troponin after CABG, they endorsed a threshold for the diagnosis of heart attack of ≥35 times the upper reference limit together with new evidence of ischemia, based on expert opinion. They also defined a threshold of ≥70 times the upper reference limit as a stand-alone criterion for clinically important periprocedural myocardial injury. Globally, many hospitals now use high-sensitivity cardiac troponin assays; however, limited data are available to define a prognostically important degree of myocardial injury after cardiac surgery based on these assays. We undertook the Vascular Events in Surgery Patients Cohort Evaluation (VISION) Cardiac Surgery Study to examine clinical outcomes after cardiac surgery. A primary objective was to determine the relationship between postoperative levels of high-sensitivity cardiac troponin I and the risk of death 30 days after cardiac surgery.  (more…)
Alzheimer's - Dementia, Author Interviews, Biomarkers / 11.11.2021

MedicalResearch.com Interview with: Joshua D. Grill, PhD Professor, Psychiatry & Human Behavior School of Medicine Professor, Neurobiology and Behavior School of Biological Sciences University of California, Irvine MedicalResearch.com: What is the background for this study? Response: Alzheimer’s disease is a major public health challenge. More than 6 million Americans have the disease, which causes cognitive problems and eventual dependence on others for daily function. Scientists understand that the disease begins in the brain years before memory and other thinking problems begin and the AHEAD Study aims to intervene in this window of time, to see if a drug that targets these brain changes can delay or prevent symptoms of the disease.   (more…)
Author Interviews, Biomarkers, Heart Disease, JAMA, Technology / 05.10.2021

MedicalResearch.com Interview with: Pinar Zorlutuna, PhD Sheehan Family Collegiate Professor of Engineering Aerospace and Mechanical Engineering Chemical and Biomolecular Engineering (Concurrent) Bioengineering Graduate Program University of Notre Dame  MedicalResearch.com: What is the background for this study? Response: Acute myocardial infarction (AMI) is the primary cause of death among cardiovascular diseases. The current clinical standard of diagnosis combines echocardiogram (ECG) and several circulating protein biomarkers from plasma. In their current state, both are incapable of distinguishing between patients with and without complete coronary occlusion, unless additional invasive testing is implemented, and both have significant false positive rates. MicroRNAs (miRNAs) have shown great potential as rapid and discriminating biomarkers for acute myocardial infarction (AMI) diagnosis. (more…)
Author Interviews, Biomarkers, COVID -19 Coronavirus, JAMA / 28.08.2021

MedicalResearch.com Interview with: Laura Holberger, PhD Vice President, Strategic Partnerships Biolabs MedicalResearch.com: What is the background for this study? Response: Dr. Laura Holberger is the lead author of a JNO article published today describing the results of a research study done on behalf of BioLabs, a global network of coworking laboratory spaces, and the Cambridge Consortium for Rapid COVID Tests (CCRCT). BioLabs co-sponsored the study which helped validate a high-frequency testing protocol using an antigen test for COVID-19 under development by E25Bio Inc., a biotechnology company that develops rapid tests for infectious diseases.  The study involved twice-weekly testing of members and affiliates working in person at coworking laboratories in Cambridge and Boston, Massachusetts from September 2020 through March 2021. (more…)
ASCO, Author Interviews, Biomarkers, Breast Cancer / 18.06.2021

MedicalResearch.com Interview with: Dr. Frank Vicini, MD, FACR, FASTRO Principal Investigator Radiation Oncologist at GenesisCare Member of NRG Oncology MedicalResearch.com: Would you briefly explain what is meant by DCIS? Response: DCIS stands for ductal carcinoma in situ and indicates the presence of abnormal cells inside a milk duct in one or both breasts. Sometimes referred to as Stage 0 (zero), it is considered the earliest form of breast cancer and is noninvasive. The tumor has not yet left the duct-- a passageway that transports milk from the breast lobules to the nipple-- and begun to invade the healthy tissue surrounding it. Standard treatment options for DCIS include surgery, radiation therapy and hormonal therapy. (more…)
Author Interviews, Biomarkers, Cancer Research, Science / 18.02.2021

MedicalResearch.com Interview with: Muhammed Murtaza M.B.B.S. (M.D.), Ph.D. Translational Genomics Research Institute Phoenix, AZ MedicalResearch.com: What is the background for this study? Response: Liquid biopsies and cell-free DNA analysis using blood samples have transformed cancer diagnostics in recent years. We started this project wondering whether cell-free DNA in urine is a viable alternative to blood, since urine could be collected completed non-invasively. Our very first experiment showed the lengths of DNA fragments in urine very similar across healthy individuals, leading us to wonder whether urine was actually as randomly degraded as we had previously thought. (more…)
Author Interviews, Biomarkers, COVID -19 Coronavirus / 25.01.2021

MedicalResearch.com Interview with: Marlene Cano MD. PhD. Post-Doctoral Research Fellow in Pulmonary Transplant Immunology Division of Pulmonary and Critical Care Department of Medicine Washington University/Barnes-Jewish Hospital Saint Louis, MO MedicalResearch.com: What is the background for this study? How does this test differ from other tests for COVID-19?   Response: We know COVID-19 causes a wide spectrum of disease, and that while many develop only mild uncomplicated illness, others develop severe respiratory failure, multi-organ failure and death. These patients often require prolonged hospitalization, ICU level care and even mechanical intubation for respiratory support. However, we still do not have a great way to identify which patients are likely to develop severe disease. We felt it was important to have a test that could act as sort of a ‘biomarker’ that we could measure early in COVID-19 patients and would help predict which patients would develop severe disease. From prior work, we knew that mitochondrial DNA, which are proinflammatory molecules that are released into the circulation from damaged organs could be this such ‘biomarker’. So, we measured the levels of mitochondrial DNA circulating in the plasma of patients with COVID-19 at the time they first presented to the hospital. Then we investigated if higher levels of mitochondrial DNA indeed predict the development of more severe disease. Currently there are no ‘biomarker’ tests specific for COVID-19. We do currently measure levels of other markers in the hospital that we feel might help us assess overall how sick patients may be, but these are very non-specific and assess only level of inflammation. This test instead can measure level of tissue injury. (more…)
Author Interviews, Biomarkers, Cancer Research / 07.10.2020

MedicalResearch.com Interview with: Padma Sundar, Senior Vice President of Commercial , OncocyteTM oncocyte.com MedicalResearch.com:  What is the background for this announcement? How common is Stage I-IIA non-squamous NSCLC?  DetermaRxTM is a treatment stratification test to identify patients with Stage I-IIA non-squamous NSCLC who may benefit from adjuvant chemotherapy.
  • Stage I-IIA non-squamous NSCLC represents ~20% of the lung cancer population and 40,000 patients annually in the U.S.1
  • Patients with this diagnosis usually undergo surgical resection and are presumed “cured”. While these patients are presumed “cured”, the recurrence rate in early-stage NSCLC of 30-50%. Usually, these recurrences happen within the first two years after surgery and are likely due to the presence of occult distant metastasis at the time of surgery.2
  • Until now, there has not been a validated means of identifying which early-stage patients are at a higher risk of disease recurrence and require adjuvant chemotherapy, versus those patients that are likely cured by surgery alone.
(more…)
Author Interviews, Biomarkers, Cancer Research / 20.08.2020

MedicalResearch.com Interview with: Dr. Alexey Aleshin, M.D., MBA Senior Medical Director Natera MedicalResearch.com: What is the background for this study? Response: Checkpoint inhibitor-based immunotherapies (ICI)  have changed the management of a range of cancers of diverse histologies. While these therapies are well tolerated and efficacious, only a minority (<20%) of patients respond to treatment or derive durable clinical benefit from them, highlighting the need for a pan-cancer biomarker that can predict response prior to, or shortly after, treatment initiation. With immune checkpoint inhibitors (ICIs) rapidly becoming a cornerstone of cancer therapy, early determination of response to ICI treatment can optimize patient benefit and minimize the risk of toxicities, while potentially reducing unnecessary treatment and costs to patients and payers. Additionally, due to the nature of immune checkpoint inhibition, atypical patterns of response have emerged. For instance, tumor pseudoprogression — a transient increase in tumor size due to the infiltration of immune cells, followed by delayed shrinkage — has been reported in as much as 10% of patients receiving ICI therapy. Distinguishing pseudoprogression from true progression is clinically important to avoid premature discontinuation of a treatment that may have future benefit, or delay the initiation of an alternative line of therapy. However, they are hard to differentiate using current imaging techniques. Our study published in Nature Cancer earlier this month, demonstrates that bespoke circulating tumor DNA (ctDNA) testing may be a valuable tool that sheds light on both of these issues. (more…)
Author Interviews, Biomarkers, Lymphoma / 14.08.2020

MedicalResearch.com Interview with: Dr. Ivana Špaková Pavol Jozef Šafárik University Košice, Slovakia MedicalResearch.com: What is the background for this study? Response:  The background is the plenty of space for studying "waste metabolites" which tell us more about the metabolism of the whole body as well as about the metabolism of the smallest compartment - cell. So we decided to study what is the difference in urine spectra (absorbance, excitation, and emission spectra) in patients with malignant melanoma and healthy subjects without positive cancer history. MedicalResearch.com: What are the main findings? Response: The main findings are "discovery" (it is not true discovery because the target molecules or metabolites are known for decades) of molecules{metabolites which together describe the stage of malignant melanoma. These findings could be used for future tracking the patient's response for treatment or for tracking the previously treated patients for malignant melanoma and are healthy at the moment of sampling. (more…)
Author Interviews, Biomarkers, COVID -19 Coronavirus / 21.07.2020

MedicalResearch.com Interview with: Gil Garnier PhD Director and Professor Bioresource Processing Research Institute of Australia (BioPRIA) PALS ARC Industry Transformation Research Hub Department of Chemical Engineering Monash University MedicalResearch.com: What is the background for this study? Response: We wanted to develop a test that would be: 1) Reliable and fast to perform, 2) Easy and fast to manufacture, 3) Easy and fast to distribute and be adopted by the Health care community. We also wanted to capitalize on our vast expertise and experience from developing novel blood typing tests. Our strategy was to develop a serology COVID test using the current Gel card technology available in most hospital and blood laboratories throughout the world. Equipment and expertise are already available from point of care setting to high throughput/automated systems measuring 100-200 test/ h. Also, these cards are currently produced by many companies all over and these can be shipped all international. (more…)
Author Interviews, Biomarkers, COVID -19 Coronavirus / 17.07.2020

MedicalResearch.com Interview with: Abdi Ghaffari, Ph.D. Associate Professor (adjunct) Dept. of Pathology and Molecular Medicine Queen’s University MedicalResearch.com: What is the background for this study? Response: SARS-CoV-2 virus has infected millions and changed our way of life by placing nearly 3 billion people under lockdown or some form of physical isolation. In the absence of a vaccine or reliable treatment, diagnostic testing must be a pillar of public health policy to control further spread of the virus and to guide gradual removal of lockdown measures. COVID-19 antibody diagnostic tests are being increasingly used to assess the protective immunity status in the population. There are over 100 different COVID-19 antibody tests developed by companies worldwide in an effort to address this need. However, companies’ reported performance data are not always in line with the actual performance of these diagnostic tests in the real-world. In this work, we conducted a systemic review of independent studies (sponsored by academic or government institutions) that aimed to validate the performance of currently available COVID-19 antibody tests on the market.  (more…)
Author Interviews, Biomarkers, Cancer Research / 28.06.2020

MedicalResearch.com Interview with: Dr. Kathryn Lang VP, Outcomes and Evidence Guardant Health  MedicalResearch.com: What is the background for this study? Response: Despite a wide variety of screening methods available and increasing public awareness of the value of early detection, colorectal cancer (CRC) remains a leading cause of cancer-related deaths.  However nearly 1 in 3 adults in the United States  is not compliant with screening recommendations, with most citing that current screening methods are time consuming, unpleasant (stool-based testing), and in the case of colonoscopy, invasive. A blood-based CRC screening test could improve compliance rates by providing physicians with an opportunistic, in-office screening modality. However, demonstrating the clinical utility of blood-based cell-free circulating tumor DNA (ctDNA) fractions  for the detection of cancer in asymptomatic individuals has thus far been challenged by the failure to achieve clinically meaningful sensitivity and specificity thresholds due to significantly lower tumor cell-free free DNA  fractions and the increasing relevance of biological confounders. The multi-modal approach of Guardant Health’s LUNAR-2 assay (genomics, methylation and fragmentomics) coupled with advanced bioinformatic analysis and a focused approach of honing in on the unique signals of CRC  has been shown in previously reported cohorts to perform with sensitivity and specificity which satisfies the needs of clinicians in screening for CRC. (more…)
AACR, Author Interviews, Biomarkers, Cancer Research, Colon Cancer / 26.06.2020

MedicalResearch.com Interview with: Guardant HealthVan Morris, M.D. Department of Gastrointestinal Medical Oncology Division of Cancer Medicine MD Anderson Center MedicalResearch.com: What is the background for this study? Response: Stage II colon cancer is diagnosed in approximately 25% of all colon cancer cases.  Oncologists do not have a reliable biomarker to identify patients who do or do benefit from adjuvant chemotherapy for this population of patients.  Circulating tumor DNA is shed by tumor cells as they die and harbors somatic mutations which distinguish its DNA from that of normal cells. Recently, circulating tumor DNA has shown great promise in distinguishing patients with colon cancer (as well as other solid tumors) that do or do not recur after surgery.  Here, patients who have detectable circulating tumor DNA - a surrogate for the presence of microscopic, minimal residual disease – inevitably recur, whereas the likelihood of recurrence is much lower for patients who do not have detectable ctDNA. (more…)
ASCO, Author Interviews, Biomarkers, Breast Cancer / 30.05.2020

MedicalResearch.com Interview with: Francois-Clement Bidard, MD PhD Head of Breast Cancer Group, Institut Curie Professor of Med. Oncology, UVSQ/Paris MedicalResearch.com: What is the background for this study? Response: A timely question is how to optimize the endocrine therapy of ER+ HER2- metastatic breast cancers? Aromatase inhibitors (AI) are currently the standard of care in first line, in combination with CDK4/6 inhibitors. Mutations in the estrogen receptor gene (ESR1) can be detected in up to 40% of AI-resistant metastatic breast cancers, but no data was available in the current first line setting (AI combined to CDK4/6 inhibitor). This exploratory study of the first line PADA-1 study reports on the detection rate of ESR1 mutations in cell-free DNA from an “AI-sensitive” population (with no metastatic relapse during adjuvant AI therapy), before the start of therapy (at inclusion). As expected, we found a low prevalence of 3.2% in the general population (N=1,017 patients included). The prevalence of ESR1 mutations among subgroups appeared primarily driven by the type of adjuvant endocrine therapy: patients with prior exposure to adjuvant therapy with AI displayed the highest prevalence of ESR1 mutations (7.1%), followed by patients with no prior adjuvant endocrine therapy (mostly de novo stage IV; ESR1 mutation prevalence: 2.4%). Patients who received adjuvant endocrine therapy with no AI (e.g. tamoxifen only) had the lowest ESR1 mutation prevalence (1.2%). (more…)