Breaking News
March 19, 2018 - Vitamin B12 supplementation could postpone disease progression in Parkinson’s patients
March 19, 2018 - Study shows that omega-6 fatty acids could protect against premature death
March 19, 2018 - TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for TX-001HR
March 19, 2018 - Minorities More Sensitive To Pain? Pain Medicine News Report
March 19, 2018 - Low blood sugar poses unaddressed threat to people with type 2 diabetes
March 19, 2018 - ACEA goes live with exhaustive, searchable library of NovoCyte publications
March 19, 2018 - Consumption of low-calorie sweeteners could promote metabolic syndrome, increase diabetes risk
March 19, 2018 - Wearable medical patch shows promise for early detection of hypoglycemia in type 1 diabetes
March 19, 2018 - High-energy breakfast leads to better diabetes control and weight loss
March 19, 2018 - D.C. Week: Community Health Centers Get Azar’s Love
March 19, 2018 - Toothpaste alone does not prevent dental erosion or hypersensitivity
March 19, 2018 - Discovery aids understanding of amyotrophic lateral sclerosis
March 19, 2018 - Docs worry there’s ‘nowhere to send’ new and expectant moms with depression
March 19, 2018 - Obesity linked to increased DNA damage in breast epithelium of BRCA mutation carriers
March 19, 2018 - Heart rate increases with higher alcohol consumption
March 19, 2018 - Template produced for clinically validated DIY stethoscope
March 19, 2018 - Experts highlight nocturia as most common cause of poor night’s sleep
March 19, 2018 - Fit Middle-Aged Women May Fend Off Dementia Later
March 19, 2018 - Fake Insta Doc; Humana’s Weird Pay Bump Tax Trick; Few NPDB Searches
March 19, 2018 - Guidelines for fluoride intake—are they appropriate?
March 19, 2018 - Race and pre-pregnancy BMI may be key predictors of maternal weight gain
March 19, 2018 - Telediabetes program improves blood sugar control for veterans
March 19, 2018 - Research suggests breastfeeding as protective factor against obesity in high-birthweight infants
March 19, 2018 - Morning Break: House Nixes ‘Right-to-Try’ Bill; Purdue’s PR Makeover; Air in the Brain
March 19, 2018 - Heart researchers develop a new, promising imaging technique for cardiac arrhythmias
March 19, 2018 - Mice study shows how BPA exposure during pregnancy can lead to altered brain development
March 19, 2018 - Breastfeeding mothers who overeat may increase risk of health problems in offspring
March 19, 2018 - New mobile application can detect atrial fibrillation that causes strokes
March 19, 2018 - Study finds low rates of preconception counseling among women of childbearing age with diabetes
March 19, 2018 - Vitl Life Science Solutions announces launch of new Lu-mini at analytica 2018
March 19, 2018 - ObsEva SA Reports Positive Topline Results from IMPLANT2 Phase 3 Clinical Trial of Nolasiban in IVF
March 19, 2018 - D.C. Week: States Plead for Federal $$ in Opioid Fight
March 19, 2018 - Polycystic ovary syndrome – Genetics Home Reference
March 19, 2018 - Reducing co-payments improves patient, physician adherence to guideline-recommended treatment post-MI
March 19, 2018 - Normalizing estrogen levels can benefit female athletes with irregular menstrual periods
March 19, 2018 - Fitness trackers and virtual coaches motivate patients to exercise post cardiac rehab
March 19, 2018 - Atrial fibrillation patients could reduce risk of dementia by taking stroke prevention drugs
March 19, 2018 - Low sperm count more prevalent with other health problems finds study
March 19, 2018 - Male birth control pill taken once a day shows success
March 19, 2018 - AcelRx Announces Receipt of Type A FDA Meeting Minutes and Plans to Resubmit the DSUVIA New Drug Application in Q2 2018
March 19, 2018 - Eye Docs Adopt EHRs Despite Reservations
March 19, 2018 - CRISPR enhances cancer immunotherapy
March 19, 2018 - Study finds first evidence of delayed aging among Americans
March 19, 2018 - Aussies unaware of sun protection rules to prevent skin cancer
March 19, 2018 - Essential oils linked to abnormal breast development in boys
March 19, 2018 - ‘Tummy Tuck’ Relieved Postpartum Back Pain/Incontinence
March 19, 2018 - New biomarkers for neuroblastoma, a type of cancer in children
March 19, 2018 - Hookah Smoking Carries a Poisoning Risk
March 19, 2018 - Do Mood and Anxiety Affect MS Disability?
March 19, 2018 - Mean depth of ultrasonographic penetration greater in autism
March 19, 2018 - Platypus milk may help combat antibiotic resistance
March 19, 2018 - U.S. IDE study of THERMOCOOL SMARTTOUCH SF Catheter completes patient enrollment
March 18, 2018 - E-cigarette use exposes adolescents to potentially cancer-causing chemicals
March 18, 2018 - GOP Senator: Solve Opioid Crisis Through Community, Not Policy
March 18, 2018 - Why is ADHD more common in boys than girls?
March 18, 2018 - Measles alert after two passengers with the disease fly into US
March 18, 2018 - FDA looks to remove nicotine from cigarettes
March 18, 2018 - FDA moves to cut nicotine in cigarettes, helping smokers kick habit
March 18, 2018 - Athenex Announces Phase II Clinical Study Results for KX2-391 Ointment for the Treatment of Actinic Keratosis
March 18, 2018 - Surgery Tied to Better Outcomes in Kids with T2D
March 18, 2018 - Scientists use nanotechnology to detect molecular biomarker for osteoarthritis
March 18, 2018 - Research establishes use of chimeric cells as potential therapy for Duchenne muscular dystrophy
March 18, 2018 - Researcher working to develop improved endoscopic probe for colonoscopies
March 18, 2018 - Researchers develop way to sequence entire fetal genome by modifying prenatal testing method
March 18, 2018 - FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application
March 18, 2018 - P2Y12 Tx Subsidy Yields Positive Response from Docs, Patients
March 18, 2018 - Are Proteins in Formula Linked to Type 1 Diabetes?
March 18, 2018 - Exercise does not seem to increase bone marrow edema in healthy people
March 18, 2018 - Researchers delineate architecture of nuclear pore complex in yeast cells
March 18, 2018 - ‘It’s Just Ghetto-izing People’: What We Heard This Week
March 18, 2018 - Alzheimer’s disease: Neuronal loss very limited
March 18, 2018 - Study reveals impact of intense, changing work schedules experienced by medical interns
March 18, 2018 - Jobs That Keep the Mind Sharp … Even Into Retirement
March 18, 2018 - Facial Scarring Improved with Botulinum Toxin
March 18, 2018 - Data detectives shift suspicions in Alzheimer’s to inside villain
March 18, 2018 - Shorter Preventive TB Tx Effective for HIV+ Patients
March 18, 2018 - New technique for identifying alcoholism puts treatment options at patients’ and providers’ fingertips
March 18, 2018 - Researchers uncover four microRNAs as potential biomarkers for atrial fibrillation
March 18, 2018 - IRX Therapeutics Announces Initiation of Phase 2 Clinical Trial of IRX-2 in Squamous Cervical or Vulvar Intraepithelial Neoplasia 3
March 18, 2018 - OncoBreak: Learning from Silence; ‘Rigged’ Drug System; NCCN Guidelines Questioned
Study validates Xpresys Lung 2 for differential diagnosis of early stage lung cancer

Study validates Xpresys Lung 2 for differential diagnosis of early stage lung cancer

image_pdfDownload PDFimage_print

Integrated Diagnostics today announced the e-publication of full results of a large prospective clinical trial validating its Xpresys Lung 2® in the peer-reviewed medical journal CHEST¸ the official journal of the American College of Chest Physicians, titled: Assessment of Plasma Proteomics Biomarker’s Ability to Distinguish Benign From Malignant Lung Nodules: Results of the PANOPTIC (PulmonAry NOdule Plasma proTeomIc Classifier) trial.

Lung nodules are a diagnostic challenge with an estimated yearly incidence of 1.6 million in the United States.  The majority of these patients have benign lung nodules, however, there are significant costs, morbidity and mortality associated with the invasive biopsies needed to determine which nodules are cancerous. These avoidable procedures are most common in patients with nodules that are low to moderate risk for cancer.

“Integrated Diagnostics pioneered the liquid biopsy approach to lung nodules based on proteomic (protein) analyses of blood plasma samples from hundreds of patients with nodules,” stated CEO Dr. Albert Luderer. “This research resulted in the discovery of several lung cancer-associated changes in a patient’s plasma proteome.”  The original findings were published in Science Translational Medicine and the Journal of Thoracic Oncology, and collectively demonstrated that specific protein changes could be detected in early stage lung cancer and utilized to exclude cancer in patients with benign nodules.

The newly published clinical validation represents the performance of the second generation diagnostic test of Integrated Diagnostic’s original published work and is termed Xpresys Lung 2 (‘XL2’).  This new test combines five standard-of-care clinical factors such as patient age and nodule size in combination with the measurement of two proteins into a single risk assessment. The validation study confirmed the high accuracy of XL2 in identifying benign nodules in patients with a pretest probability of malignancy of 50% and less.

Co-authors Paul Kearney, PhD and Steven Springmeyer, MD commented that:

to establish a high level of evidence, we conducted two prospective studies, one for discovery and the other for validation that focused only on Stage 1A lung nodules. This is incredibly important as these are the lung nodules that are the hardest to assess. We integrated clinical risk factors and found that the proteomic signal was additive to the clinical risk factors. So in a real sense, XL2 is providing physicians with a molecular insight that they have never had before.

“The outcomes of the PANOPTIC prospective, multi-center, observational trial are significant as they validate a new approach leveraging the proteome –– to accurately distinguish between benign and malignant nodules to rule out early stage lung cancer,” added senior author Dr. Peter Mazzone, MD, MPH, Cleveland Clinic, Director of the Lung Cancer Program and Lung Cancer Screening Program for the Respiratory Institute. “Through this large-scale research, we have shown that this may provide the needed objective assessment of lung nodules to better determine the best treatment path forward, which could reduce or avoid invasive biopsy or surgery procedures and create improved patient outcomes.”

State-of-art instrumentation used multiple reaction monitoring mass spectrometry to measure the relative abundance of two plasma proteins, LG3BP and C163A.  These proteins were integrated into a ratio that is associated with the malignant condition – LG3BP is elevated and C163A is diminished.

The low to moderate risk subgroup of 178 patients with a clinician assessed pCA≤50% had a 16% prevalence of lung cancer. XL2 demonstrated a sensitivity of 97% (CI 82%-100%), a specificity of 44% (CI 36%-52%) and a negative predictive value (NPV) of 98% (CI 92%-100%) in distinguishing benign from malignant nodules. When XL2 performance was contrasted to other standard-of-care diagnostic modalities performed on these patients, the classifier performed better than all other modalities including positron emission tomography (PET), validated lung nodule risk models and physician estimated cancer probability  (p<0.001).  If the integrated classifier results were used to direct care, 40% fewer procedures would be performed on benign nodules while only 3% of malignant nodules would be misclassified. This low XL2 error rate contrasts dramatically to the trial’s observed standard of care misclassification of cancers (45%).


Tagged with:

About author

Related Articles