Author Interviews, Biomarkers, Cancer Research, Science / 18.02.2021

MedicalResearch.com Interview with: [caption id="attachment_56720" align="alignleft" width="163"]Muhammed Murtaza M.B.B.S. (M.D.), Ph.D. Translational Genomics Research Institute Phoenix, AZ Dr. Murtaza[/caption] 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.
Author Interviews, Biomarkers, COVID -19 Coronavirus / 25.01.2021

MedicalResearch.com Interview with: [caption id="attachment_56468" align="alignleft" width="167"]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 Dr. Cano[/caption] 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.
Author Interviews, Biomarkers, Cancer Research / 07.10.2020

[caption id="attachment_55592" align="alignleft" width="133"]Padma Sundar, Senior Vice President of Commercial , OncocyteTM Padma Sundar[/caption] 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.
Author Interviews, Biomarkers, Cancer Research / 20.08.2020

MedicalResearch.com Interview with: [caption id="attachment_55158" align="alignleft" width="200"]Dr. Alexey Aleshin, M.D., MBA Senior Medical Director Natera Dr. Aleshin[/caption] 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.
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.
Author Interviews, Biomarkers, COVID -19 Coronavirus / 21.07.2020

MedicalResearch.com Interview with: [caption id="attachment_54906" align="alignleft" width="125"]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  Prof. Garnier[/caption] 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.
Author Interviews, Biomarkers, COVID -19 Coronavirus / 17.07.2020

MedicalResearch.com Interview with: [caption id="attachment_54883" align="alignleft" width="155"]Abdi Ghaffari, Ph.D. Associate Professor (adjunct) Dept. of Pathology and Molecular Medicine Queen’s University Dr. Ghaffari[/caption] 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. 
Author Interviews, Biomarkers, Cancer Research / 28.06.2020

MedicalResearch.com Interview with: [caption id="attachment_54740" align="alignleft" width="142"]Dr. Kathryn Lang VP, Outcomes and Evidence Guardant Health  Dr. Lang[/caption] 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.
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.
ASCO, Author Interviews, Biomarkers, Breast Cancer / 30.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54388" align="alignleft" width="200"]Francois-Clement Bidard, MD PhD Head of Breast Cancer Group, Institut Curie Professor of Med. Oncology, UVSQ/Paris  Dr. Clement Bidard[/caption] 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%).
AACR, Author Interviews, Biomarkers, Cancer Research, MD Anderson, Pharmaceutical Companies / 09.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54143" align="alignleft" width="140"]David S Hong, M.D Department of Investigational Cancer Therapeutics, Division of Cancer Medicine MD Anderson, University of Texas Dr. Hong[/caption] David S Hong, M.D MD Anderson Department of Investigational Cancer Therapeutics Division of Cancer Medicine University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated robust tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. In this analysis presented at AACR 2020, we sought to evaluate the outcomes in patients from the integrated data set based on different baseline characteristics, including prior lines of therapy and Eastern Cooperative Oncology Group (ECOG) performance status. ECOG measures how the disease impacts a patient. ECOG describes a patient’s level of functioning with a numbering scale (0-5) so physicians can uniformly describe a patient’s ability to care for themselves, daily activity and physical activity (selfcare, walking, working, etc).
Author Interviews, Biomarkers, Gastrointestinal Disease / 28.03.2020

MedicalResearch.com Interview with: [caption id="attachment_53680" align="alignleft" width="200"]Jean-Frederic Colombel MD The Henry D Janowitz Division of Gastroenterology Icahn School of Medicine at Mount Sina New York, NY 10029, USA Dr. Colombel[/caption] Jean-Frederic Colombel MD The Henry D Janowitz Division of Gastroenterology Icahn School of Medicine at Mount Sina New York, NY 10029, USA MedicalResearch.com: What is the background for this study? Response: The goals of therapy in Crohn’s disease have shifted from mere control of symptoms also called clinical remission towards combination of clinical and endoscopic remission also called deep remission which is now considered as the new therapeutic “target”. However it has yet to be proven that targeting deep remission instead of clinical remission is able to stop the progression of Crohn’s disease towards bowel damage, complications and hospitalizations. This study is a post-hoc analysis of the CALM trial that was published in The Lancet in 2018 where newly diagnosed patients were randomized to escalate therapy based on symptoms only (control arm) or based on a combination of symptoms and two biomarkers namely C-reactive protein in blood and calprotectin in stools (tight control arm).
Author Interviews, Biomarkers, Diabetes, Diabetes Care, Johns Hopkins / 26.03.2020

MedicalResearch.com Interview with: [caption id="attachment_53641" align="alignleft" width="150"]Olive Tang, MD/PhD Student Johns Hopkins School of Medicine Olive Tang[/caption] Olive Tang, MD/PhD Student Johns Hopkins School of Medicine   [caption id="attachment_53642" align="alignleft" width="150"]Elizabeth Selvin, PhD, MPH Professor of Epidemiology & Medicine Director, Cardiovascular and Clinical Epidemiology  Department of Epidemiology Welch Center for Prevention, Epidemiology and Clinical Research and the Johns Hopkins Bloomberg School of Public Health Dr. Selvin[/caption] Elizabeth Selvin, PhD, MPH Professor of Epidemiology & Medicine Director, Cardiovascular and Clinical Epidemiology Department of Epidemiology Welch Center for Prevention, Epidemiology and Clinical Research and the Johns Hopkins Bloomberg School of Public Health MedicalResearch.com: What is the background for this study? Response: The best approach to diabetes management in older adults is unclear. A new blood test called high-sensitivity troponin can detect damage to the heart, even in people without any signs or symptoms of heart disease.
Author Interviews, Biomarkers, Lung Cancer, Stanford / 09.03.2020

MedicalResearch.com Interview with: [caption id="attachment_53410" align="alignleft" width="149"]Professor Dr. Andreas Keller Stanford University School of Medicine Office Department of Neurology and Neurological Sciences  Chair for Clinical Bioinformatics Saarbrücken, Germany Prof. Keller[/caption] Professor Dr. Andreas Keller Stanford University School of Medicine Office Department of Neurology and Neurological Sciences Chair for Clinical Bioinformatics Saarbrücken, Germany MedicalResearch.com: What is the background for this study? Response: Lung cancer is among the three most common cancers and the leading cause of cancer-related deaths worldwide. The overall low survival rate of patients with lung cancer calls for improved detection tools to enable better treatment options and improved patients’ outcomes. To detect lung tumors, liquid biopsy-based strategies are increasingly explored, that are biomarkers, which are identifiable in body fluids such as human blood. The clinical application of biomarkers is, however, largely hampered by the relatively small numbers of cases that have been analyzed in the majority of the preclinical studies including the studies on lung cancer. 
Alzheimer's - Dementia, Author Interviews, Biomarkers, Heart Disease / 25.02.2020

MedicalResearch.com Interview with: [caption id="attachment_53293" align="alignleft" width="200"]Prof. Konstantinos Stellos, MD, DM, MRCP, DSc, FAHA, FESC Professor of Medicine, Chair of Cardiovascular Medicine, Chair of Epitranscriptomics Lead, Vascular Biology & Medicine Theme Hon. Consultant Cardiologist, Newcastle Hospitals NHS Foundation Trust Biosciences Institute Faculty of Medical Sciences Newcastle University Prof. Stellos[/caption] Prof. Konstantinos Stellos, MD, DM, MRCP, DSc, FAHA, FESC Professor of Medicine, Chair of Cardiovascular Medicine, Chair of Epitranscriptomics Lead, Vascular Biology & Medicine Theme Hon. Consultant Cardiologist, Newcastle Hospitals NHS Foundation Trust Biosciences Institute Faculty of Medical Sciences Newcastle University MedicalResearch.com: What is the background for this seminar? Can you tell us a little about how amyloid is made and stored? Response: Patients are afraid that they may die due to a heart attack - a major cause of death worldwide- or if they live long they may get dementia compromising severely their quality of life in their last years of life. Many years ago we asked the question whether there is a link between these two ageing-associated diseases. For this reason we studied the clinical value of amyloid-beta peptides in patients with coronary heart disease. We chose to study the amyloid-beta peptides, which are the cleavage product of the beta- and gamma-secretases of the mother protein amyloid precursor protein, because amyloid-beta plaques in brain is the hallmark of Alzheimer's disease. Following amyloid precursor protein (APP) gene transcription, APP is cleaved in the nonamyloidogenic pathway (plasma membrane) by α- and γ- secretases or in the amyloidogenic pathway (endosomes) by β- and γ- secretases. The later pathway generates amyloid beta (Αβ) peptides that are released extracellularly. Αβ accumulation in blood or tissues may result from enhanced production/cleavage or by impaired degradation and/or clearance. The related mechanisms are depicted in Figure 2 of our publication in JACC: http://www.onlinejacc.org/content/75/8/952 
Author Interviews, Biomarkers, Heart Disease, JAMA, UCLA / 09.01.2020

MedicalResearch.com Interview with: [caption id="attachment_52737" align="alignleft" width="191"]Olujimi A. Ajijola, MD, PhD Neurocardiology Research Center of Excellence Cardiac Arrhythmia Center University of California, Los Angeles Olujimi A. Ajijola, MD, PhD[/caption] Olujimi A. Ajijola, MD, PhD Neurocardiology Research Center of Excellence Cardiac Arrhythmia Center University of California, Los Angeles MedicalResearch.com: What is the background for this study? Response: It hadn’t been understood why some people with basic heart failure might live longer than others despite receiving the same medications and medical device therapy. Through this research we set out to determine whether a biomarker of the nervous system could help explain the difference. This study revealed a biomarker that can specifically predict which patients with “stable” heart failure have a higher risk of dying within one to three years.
Annals Internal Medicine, Author Interviews, Biomarkers, Heart Disease / 23.12.2019

MedicalResearch.com Interview with: [caption id="attachment_52542" align="alignleft" width="150"]Dr. PJ Devereaux MD, PhD, FRCP(C) Director of the Division of Cardiology Scientific Leader, Anesthesiology, Perioperative Medicine, and Surgical Research Group Population Health Research Institute McMaster University Dr. Devereaux[/caption] Dr. PJ Devereaux MD, PhD, FRCP(C) Director of the Division of Cardiology Scientific Leader Anesthesiology, Perioperative Medicine, and Surgical Research Group Population Health Research Institute McMaster University  MedicalResearch.com: What is the background for this study? Response: There is an ethical obligation to provide patients with an accurate estimation of the potential benefits of surgery and the potential risks, to facilitate informed decision making about the appropriateness of surgery.  There are two common approaches to risk estimation. First, physicians commonly use clinical risk indices.  Based upon a patient’s clinical history (e.g., history of prior heart attack or stroke) an estimate of perioperative risk is determined.  Research demonstrates that these clinical risk indices have suboptimal risk discrimination capabilities, and they will underestimate risk in many patients. The second approach that has commonly been used is to have patients undergo an expensive and time consuming non-invasive cardiac test (e.g., stress nuclear cardiac study).  Although these non-invasive cardiac tests can enhance risk estimation in some patients who will have a perioperative cardiac event, these tests more commonly exaggerate risk in patients who will not have a complication.
Author Interviews, Biomarkers, Cancer Research / 21.12.2019

MedicalResearch.com Interview with: https://www.kariusdx.com/ Dr. Asim Ahmed MD co-author of the study Senior medical director at Karius  MedicalResearch.com: What is the background for this study? Would you briefly explain the basis of the Karius Test? Response: The Karius Test is a non-invasive blood test that uses next-generation sequencing of microbial cell-free DNA to rapidly detect over 1,400 bacteria, DNA viruses, fungi, and other pathogens. Doctors primarily use the test to detect specific causative pathogens, complicated pneumonia, cardiovascular infections, and infections in immunocompromised hosts. The Karius Test is transforming how doctors diagnose infectious diseases by helping doctors identify the precise pathogens infecting patients. The Karius Test offers a higher diagnostic yield and faster time-to-diagnosis than conventional tests - with the potential to eliminate invasive diagnostic procedures like biopsies.
Author Interviews, Biomarkers, Hematology, Transplantation / 09.12.2019

MedicalResearch.com Interview with: [caption id="attachment_52340" align="alignleft" width="163"]Hrishikesh Srinagesh MD The Tisch Cancer Institute at Mount Sinai Dr. Srinagesh[/caption] Hrishikesh Srinagesh MD The Tisch Cancer Institute at Mount Sinai MedicalResearch.com: What is the background for this study? Response: Graft-versus-host disease (GVHD) is the leading cause of non-relapse mortality (NRM) after allogeneic hematopoietic cell transplantation (HCT). Acute GVHD occurs in approximately 50% of HCT patients and targets the skin, liver, and gastrointestinal tract primarily. The change in clinical symptoms (e.g. reduction in volume of diarrhea) is used as the primary endpoint in most trials of acute GVHD treatment, but more accurate metrics are needed to predict long-term survival. Over the past decade, the Mount Sinai Acute GVHD International Consortium (MAGIC) has studied two biomarkers important in GVHD pathogenesis: suppressor of tumorigenesis 2 (ST2) and regenerating islet-derived 3 alpha (REG3). These proteins are shed into the bloodstream when the gastrointestinal tract is damaged during GVHD, the most lethal form of acute GVHD. The concentrations of ST2 and REG3 can be used generate an individual’s estimated probability of 6 month NRM known as the MAGIC Algorithm Probability (MAP). Our study evaluated whether the MAP measured at the start of GVHD treatment and four weeks later could predict long-term survival and we compared the MAP to clinical response after four weeks, the gold standard of response. 
Author Interviews, Biomarkers, Prostate Cancer / 02.12.2019

MedicalResearch.com Interview with: Dr Jeremy Clark University of East Anglia Norwich Medical School MedicalResearch.com: What is the background for this study? Response: Earlier this year we published our pilot study which showed how useful we have found urine to be for diagnosing prostate cancer and predicting which cancers will get bigger and nastier up to 5 years later (Connell et al 2019). – Our PUR (Prostate Urine Risk) signatures separated men with low-risk cancer into two groups one of which had 8-times the rate of future development of aggressive cancer that the other. There is nothing in clinical use at present that can do this. The new development is our At-Home Urine collection system which means that we can now send out a urine collection kit to a man at home, he fills up a small pot with his first wee of the day and posts it back to us for PUR analysis. This makes the whole system so much less stressful for the patient. The idea behind it is as follows: the prostate lays just below the bladder, it is a secretory organ and these secretions carry cells and molecules from all over the prostate to the urethra which then get flushed out of the body on urination. If a cancer is present then tiny bits of the tumour are also carried with the secretions and we can detect these in the urine. As the prostate is constantly secreting the levels of biomarkers in the urethra will build up with time. Collecting from the first wee of the day means that overnight secretions can be collected which makes the analysis more sensitive and more robust.
Author Interviews, Biomarkers, Melanoma, Ophthalmology / 15.11.2019

MedicalResearch.com Interview with: [caption id="attachment_52167" align="alignleft" width="200"]Dr Mitchell Stark, B.App.Sc (Hons), PhD NHMRC Research Fellow The University of Queensland Diamantina Institute Woolloongabba, QLD  Dr. Stark[/caption] Dr. Mitchell Stark, B.App.Sc (Hons), PhD NHMRC Research Fellow The University of Queensland Diamantina Institute Woolloongabba, QLD MedicalResearch.com: What is the background for this study? Response: Uveal nevi (moles) mimic the appearance of uveal melanoma and their transformation potential cannot be definitively determined without a biopsy. Moles or naevi in the eye are common but can be difficult to monitor because changes to their shape or colouring can’t always be seen as easily as on the skin. As naevi are difficult to biopsy, they are usually “monitored” at regular intervals. If there is a melanoma in the eye, then outcomes are poor for people if their cancer spreads to the liver. This study aimed to identify a “biomarker” that could be measured in patients’ blood that could be used as an early indicator of melanoma formation (from a mole) or progression to other body sites. 
Author Interviews, Biomarkers, Schizophrenia / 29.10.2019

[caption id="attachment_51978" align="alignleft" width="200"]Dr.  Takeo Yoshikawa MD PhD RIKEN Center for Brain Science Japan Dr. Yoshikawa[/caption] MedicalResearch.com Interview with: Dr.  Takeo Yoshikawa MD PhD RIKEN Center for Brain Science Japan MedicalResearch.com: What is the background for this study? What are the main findings?
  • Currently available drugs for schizophrenia are the dopamine D2 receptor blockers. These compounds were serendipitously discovered over half-century ago. But about 30% of schizophrenia are resistant to the dopamine D2 receptor blockers. In spite of these conditions, pharmaceutical companies have abandoned the development of new drugs. This is because we do not know the principle of drug design.
  • Therefore, we need to understand the molecular underpinning of as-yet unknown schizophrenia pathophysiology. Schizophrenia is diagnosed by only patients’ symptoms, not by biological examination. To search for biological underpinning for schizophrenia using experimental animals, we thought that we should examine an endophenotype (biological trait) relevant to schizophrenia. Then we targeted prepulse (PPI) performance.
  • Here, dampened PPI is considered as a biological marker of psychiatric disorders, typically of schizophrenia. Importantly, PPI can be measured using the same behavioral paradigm between experimental animals and human.
  • C57BL/6 (B6) inbred mouse shows higher (better) prepulse inhibition (PPI) performance, while C3H/He (C3H) inbred mouse shows lowered (worse ) PPI. We premised that C3H mouse is “schizophrenia-prone” and B6 is not. To know the molecular basis for differential PPI levels between the two inbred mouse strains, we performed comprehensive protein expression level analysis (proteomics analysis) using the brains of B6 and C3H mice.
  • The expression levels of Mpst, a hydrogen sulfide (H2S)-producing enzyme, is elevated in C3H mouse compared to B6 mouse. Biochemical analysis also supported the elevated H2S production in C3H mouse compared to B6.
  • The examination of human samples including postmortem brains, iPS-derived neural stem cells (neurospheres) and hair follicle cells, gave evidence that H2S production system is indeed up-regulated in schizophrenia.
Author Interviews, Biomarkers, JAMA, Pediatrics / 09.09.2019

MedicalResearch.com Interview with: [caption id="attachment_28740" align="alignleft" width="200"]Elizabeth D. Kantor, PhD MPH Department of Epidemiology and Biostatistics Memorial Sloan Kettering Cancer Center NY, NY Dr. Elizabeth D. Kantor[/caption] Elizabeth D. Kantor, PhD MPH Department of Epidemiology and Biostatistics Memorial Sloan Kettering Cancer Center NY, NY MedicalResearch.com: What is the background for this study? Response: There has been recent interest in understanding how exposures in childhood and adolescence relate to later-life health outcomes. Although inflammation is thought to play a role in the etiology of various diseases, little is known about the long-term implications of inflammation in early life. We therefore sought to evaluate how erythrocyte sedimentation rate (ESR), a marker of inflammation, measured among ostensibly healthy men in late adolescence, relates to subsequent cause-specific mortality. We found that men with high inflammation in late adolescence experienced increased mortality due to cancer and cardiovascular disease.
Author Interviews, Biomarkers, Brain Injury, Emergency Care, Pediatrics / 31.08.2019

MedicalResearch.com Interview with: [caption id="attachment_51109" align="alignleft" width="160"]Linda Papa, MD Emergency Physicians of Central Florida Orlando Health Orlando, Florida Dr. Papa[/caption] Linda Papa, MD Emergency Physicians of Central Florida Orlando Health Orlando, Florida  MedicalResearch.com: What is the background for this study? Response: In 2018 serum biomarkers Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal hydrolase (UCH-L1) were FDA-approved in adults to detect abnormalities on CT scan in mild to moderate traumatic brain injury. However, they have not been approved to detect concussion and they have not been approved for use in children. Previous studies have focused on detecting lesions on CT in more severely injured patients. However, not having brain lesions on a CT scan does not mean there is no brain injury or concussion. Therefore, this study focused on patients with concussion who looked well and likely had normal-appearing CT scans of the brain. This study includes THREE groups of trauma patients:
  • 1) those with concussion,
  • 2) those who hit their head but had no symptoms (subconcussive), and
  • 3) those who injured their bones but did not hit their head (no concussion).
There is a group of individuals with head trauma who have been significantly understudied, and in whom biomarkers are rarely, if at all, examined. These are people who experience head trauma without symptoms of concussion. They may be classified as having “no injury” or they may represent milder forms of concussion that do not elicit the typical signs or symptoms associated with concussion and are referred to as “subconcussive” injuries. 
Author Interviews, Biomarkers, Cancer Research / 05.08.2019

MedicalResearch.com Interview with: [caption id="attachment_50542" align="alignleft" width="158"]Emeritus Professor Attila Lorincz, PhD Centre for Cancer Prevention Queen Mary University of London Dr. Lorincz[/caption] Emeritus Professor Attila Lorincz, PhD Centre for Cancer Prevention Queen Mary University of London  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The vast majority of women with cervical lesions are not at risk for cancer, however, because there is no way to accurately identify the very small proportion of women at risk of cervical cancer a recommendation for treatment is commonly given by doctors. Surgery on women with cervical lesions is risky for future pregnancies and can cause harm to the baby. Occasionally there are also problems in physical recovery and the mental well-being of the treated women. We wanted to see if the S5 DNA methylation test could identify the women who need treatment. We ran a two-year follow-up study on 149 young women with moderate dysplasia in Finland. Our results showed that the S5 test was by far the best method to reveal which women needed treatment. 
Author Interviews, Biomarkers, Heart Disease, JACC / 17.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50312" align="alignleft" width="100"]Dr. Fred Apple, PhD, DABCC Medical director,Clinical Laboratories, Clinical Chemistry, Clinical and Forensic Toxicology and Point of Care Testing, Hennepin HealthCare Principal investigator, Minneapolis Medical Research Foundation Professor, Department of Laboratory Medicine and Pathology University of Minnesota Dr. Apple[/caption] Dr. Fred Apple, PhD, DABCC Medical director,Clinical Laboratories, Clinical Chemistry, Clinical and Forensic Toxicology and Point of Care Testing, Hennepin HealthCare Principal investigator, Minneapolis Medical Research Foundation Professor, Department of Laboratory Medicine and Pathology University of Minnesota  MedicalResearch.com: What is the background for this study? Response: Few studies have addressed the role of high sensitivity cardiac troponin (hs-cTn) assays in ruling out myocardial infarction (MI) based on the measurement of a single baseline specimen in US patients presenting to the emergency department with symptoms suggestive of ischemia. Most studies have been published predicated on patients in Europe, Australia, and New Zealand. As US emergency departments have different ordering practices for using cTn in triaging patients, it is important to validate the role of hs-cTn assays in US practices to assure providers of appropriate utilization. We have published two papers using the Abbott ARCHITECT hs-cTnI assay, the same one used outside the US in clinical practice (as this assay is not yet FDA cleared) in a US cohort (clinicialtrials.gov trial: UTROPIA - Sandoval Y, Smith SW, Shah ASV, Anand A, Chapman AR, Love SA, Schulz K, Cao J, Mills NL, Apple FS. Rapid rule-out of acute myocardial injury using a single high-sensitivity cardiac troponin I measurement. Clin Chem 2017;63:369-76. Sandoval Y, Smith SW, Love SA,  Sexter A, Schulz K, Apple FS. Single high-sensitivity cardiac troponin I to rule out myocardial infarction. Am J Med 2017;130:1076-1083) that have shown similar rule out capacities predicated on clinical presentation, a normal ECG and the role of hs-cTnI testing.
Author Interviews, Biomarkers, NEJM, Pulmonary Disease / 11.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50147" align="alignleft" width="200"]Dr. Chris Butler,, BA MBChB DCH CCH MD FRCGP (Hon)FFPH FMedSci Professor of Primary Care Nuffield Department of Primary Care Health Sciences, Professorial Fellow at Trinity College Clinical Director Primary Care Clinical Trials Unit University of Oxford Dr. Butler[/caption] Dr. Chris Butler,, BA MBChB DCH CCH MD FRCGP (Hon)FFPH FMedSci Professor of Primary Care Nuffield Department of Primary Care Health Sciences, Professorial Fellow at Trinity College Clinical Director Primary Care Clinical Trials Unit University of Oxford  MedicalResearch.com: What is the background for this study? Response: More than a million people in the UK have COPD, which is a lung condition associated with smoking and other environmental pollutants. People living with the condition often experience exacerbations, or flare-ups, and when this happens, three out of four are prescribed antibiotics. However, two-thirds of these flare-ups are not caused by bacterial infections and antibiotics often do not benefit patients. A simple finger-prick blood test could help prevent unnecessary prescribing of antibiotics for people with the lung condition chronic obstructive pulmonary disease (COPD).  The finger-prick test measures the amount of C- reactive protein (CRP) - a marker of inflammation that rises rapidly in the blood in response to serious infections. People with a COPD flare-up who have a low CRP level in the blood appear to receive little benefit from antibiotic treatment. The General Practitioner (GP) use of a C-Reactive Protein (CRP) Point of Care Test (POCT) to help target antibiotic prescribing to patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) who are most likely to benefit (The PACE Study) determined whether the using a POCT CRP to guide antibiotic treatment decisions for acute exacerbations of COPD reduced antibiotic use without harming patients.
Author Interviews, Biomarkers, Geriatrics, Heart Disease, JACC / 02.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50008" align="alignleft" width="149"]Martin Bødtker Mortensen, læge PhD Afdelingen for Hjertesygdomme Aarhus Universitetshospital Danmark Dr. Mortensen[/caption] Martin Bødtker Mortensen, læge PhD Afdelingen for Hjertesygdomme Aarhus Universitetshospital Danmark  MedicalResearch.com: What is the background for this study?   Response: The background for the study is a combination of two things: First, the proportion and number of elderly people 65 years of age or older are increasing fast worldwide. Second, given the dominant impact of age on estimated risk for cardiovascular disease, nearly all elderly individuals eventually become statin eligible under current guidelines – just because of aging alone. Thus, to limit overtreatment of elderly individuals, we wanted to find “negative” risk markers that can be used to identify elderly individuals at truly low cardiovascular risk who are less likely to benefit from statin therapy despite advancing age.
ALS, Alzheimer's - Dementia, Author Interviews, Biomarkers, JAMA, Multiple Sclerosis / 27.06.2019

MedicalResearch.com Interview with: [caption id="attachment_50018" align="alignleft" width="200"]Charlotte E. Teunissen, Prof. Teunissen[/caption] Charlotte E. Teunissen, PhD Neurochemistry Laboratory, Department of Clinical Chemistry VU University Medical Centre, Neuroscience Campus Amsterdam Amsterdam, the Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: Several reports have shown increased in NfL in various neurological disorders, separately. We wanted to know how the levels are in these disorders relative to each other. Moreover, some reports showed absence of age effects in Multiple Sclerosis (MS) patients, which is normally present in controls. So, we thought that it would be good to study age effects in a large group of controls, and if these effects are absent in other diseases, similarly as in MS.
ASCO, Author Interviews, Biomarkers, Colon Cancer / 24.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49962" align="alignleft" width="132"]Lawrence LaPointe, Ph.D. Chief Innovation Officer Clinical Genomics Bridgewater, New Jersey  Dr. LaPointe[/caption] Lawrence LaPointe, Ph.D. Chief Innovation Officer Clinical Genomics Bridgewater, New Jersey  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Colorectal cancer is a cancer of the colon and the rectum. The American Cancer Society estimates that about 1 in 21 men and 1 in 23 women in the United States will develop colorectal cancer during their lifetime. This disease is the second leading cause of cancer death in women, and the third for men. Colorectal cancer has a high 5-year recurrence rate and most likely is spread to the liver and lungs. Clinical Genomics has two decades of experience striving to save lives and reduce costs by developing easy-to-use tests for the detection of colorectal cancer. With breakthrough diagnostic tools, the company aims to offer affordable and accurate tests, supporting physicians and patients with potential life-saving knowledge about colorectal cancer. On June 3, 2019, Clinical Genomics presented research detailing breakthrough methods of colorectal cancer recurrence monitoring at the American Society of Clinical Oncology (ASCO) annual meeting in the McCormick Place Convention Center, Chicago.