Polymerase chain reaction

U.S. Infectious Respiratory Disease Diagnostics Market Report 2023: High Prevalence Of Infectious Respiratory Diseases Bolsters Growth - ResearchAndMarkets.com

Retrieved on: 
Wednesday, April 12, 2023
Health, Infectious Diseases, EUA, Chapter Four, ELISPOT, Prevalence, Urinary tract infection, COVID-19, Infection, Immunoassay, American Thoracic Society, USD, COVID-19 testing, Chapter Three, Scope, Government, CDC, Incidence, PerkinElmer, RSV, Non-governmental organization, Investment, Patient, Tuberculosis, Laboratory, Polymerase chain reaction, Mass vaccination, Diagnosis, Latent tuberculosis, RT, Pneumonia, Automation, Disease, Medical device, Vaccine, Pharmaceutical industry

However, the U.S. infectious respiratory disease diagnostics market is expected to be driven by technological advancements, an increase in the prevalence of infectious respiratory diseases, and high R&D investments by the key players, government, & NGOs to develop novel & innovative products to address the increased market demand.

Key Points: 
  • However, the U.S. infectious respiratory disease diagnostics market is expected to be driven by technological advancements, an increase in the prevalence of infectious respiratory diseases, and high R&D investments by the key players, government, & NGOs to develop novel & innovative products to address the increased market demand.
  • The introduction of innovative products used for disease diagnosis is anticipated to fuel the U.S. respiratory infectious disease market growth.
  • Thus, the increasing incidence of respiratory infections is expected to drive the U.S. infectious respiratory disease diagnostics market during the study period.
  • However, its share is expected to decline to 69.97% by 2030 due to the mass vaccination drives being conducted in the U.S., which, in turn, will reduce the rate of diseases
    Chapter 3 U.S. Infectious Respiratory Disease Diagnostics Market Variables, Trends, And Scope
    3.3.1 High Prevalence Of Infectious Respiratory Diseases In U.S.
    Chapter 4 U.S. Infectious Respiratory Disease Diagnostics Market: Segment Analysis, By Product Type, 2018 - 2030 (USD Million)
    4.2 U.S. Infectious Respiratory Disease Diagnostics Market: Product Type Movement Analysis

Global Biomarker Technologies Market to 2027: Escalating Demand for Early and Effective Diagnosis Drives Growth

Retrieved on: 
Tuesday, April 11, 2023
DNA, Systemic disease, Infection, NGS, COVID-19, Cancer, Immunoassay, Research, DSM-IV codes, Biomarker, RNA, Developed country, Polymerase chain reaction, Machine learning, Drug discovery, Artificial intelligence, Diagnosis, Growth, R, PCR, Pharmaceutical industry, Medical imaging, Potash

This, coupled with the escalating demand for early and effective diagnosis, represents one of the key factors positively influencing the market.

Key Points: 
  • This, coupled with the escalating demand for early and effective diagnosis, represents one of the key factors positively influencing the market.
  • Key Questions Answered in This Report:
    How has the global biomarker technologies market performed so far and how will it perform in the coming years?
  • What has been the impact of COVID-19 on the global biomarker technologies market?
  • What is the structure of the global biomarker technologies market and who are the key players?

Molecular Designs releases their new Simplicity™ Gastrointestinal Pathogen Panel

Retrieved on: 
Tuesday, April 11, 2023
GMP, STEC, Yersinia enterocolitica, Clostridioides difficile, ISO, Molecular design software, ETEC, Research, Escherichia coli, Entamoeba histolytica, Rotavirus, Giardia duodenalis, Dicarboxylic acid, EIEC, Polymerase chain reaction, Laboratory, Adenoviridae, GI, PCR, Pharmaceutical industry, Campylobacter

BIRMINGHAM, Ala., April 11, 2023 /PRNewswire/ -- Molecular Designs, a developer and manufacturer of molecular infectious disease assays , announces the release of its new Simplicity™ Gastrointestinal Pathogen Panel for the detection of causative agents of gastrointestinal (GI) tract infections.

Key Points: 
  • BIRMINGHAM, Ala., April 11, 2023 /PRNewswire/ -- Molecular Designs, a developer and manufacturer of molecular infectious disease assays , announces the release of its new Simplicity™ Gastrointestinal Pathogen Panel for the detection of causative agents of gastrointestinal (GI) tract infections.
  • The GI panel is a multiplex PCR assay that identifies nucleic acids from 16 different organisms, from a single sample.
  • Molecular Designs assays are manufactured to GMP and ISO 13485:2016 standards and are compatible with most PCR platforms.
  • "Our Simplicity Gastrointestinal Pathogen Panel is available to reference and hospital laboratories," said Robert Crisp , Ph.D., Vice President of Research & Development at Molecular Designs.

FDA Converts to Full Approval Indication for KEYTRUDA® (pembrolizumab) for Certain Adult and Pediatric Patients With Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors

Retrieved on: 
Wednesday, March 29, 2023
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Histology, Hepatocellular carcinoma, Cohort, DOR, RECIST, Carcinoma, Head, Vaginal cancer, Patient, Division, Mesothelioma, Immunohistochemistry, NYSE, Prostate cancer, MMR, Glomus tumor, Oxaliplatin, MRK, Toxicity, Research, Brain, Nephritis, Merck & Co., Sarcoma, HIV disease progression rates, Cervical cancer, Polymerase chain reaction, MSI, Memorial Sloan Kettering Cancer Center, MSI-H, Pancreatic cancer, Hepatitis, Vulvar cancer, Cancer, Pneumonitis, Bladder cancer, Cholangiocarcinoma, Immunotherapy, Autoimmune disease, Irinotecan, Testicular cancer, Ovarian cancer, Thyroid cancer, ORR, Hematopoietic stem cell transplantation, Anal cancer, Colitis, Endometrial cancer, Immunosuppression, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Breast cancer, Pharmaceutical industry, Vaccine, Merck

This marks the first full approval for an immunotherapy based on a predictive biomarker, regardless of solid tumor type.

Key Points: 
  • This marks the first full approval for an immunotherapy based on a predictive biomarker, regardless of solid tumor type.
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • Patients were either prospectively enrolled with MSI-H/dMMR tumors (Cohort K) or retrospectively identified in one of 10 solid tumor cohorts (Cohorts A-J).
  • In KEYNOTE-158 and KEYNOTE-164, the median duration of exposure to KEYTRUDA was 6.2 months (range, 1 day to 53.5 months).

JOURNAL OF MEDICAL INTERNET RESEARCH | CAN ARTIFICIAL INTELLIGENCE BE USED TO DIAGNOSE INFLUENZA?

Retrieved on: 
Tuesday, March 28, 2023
Telehealth, Medicine, Use, Pharynx, Journal of Medical Internet Research, Disease, Deep learning, COVID-19, Research, Publication, Epidemic, Report, Pandemic, Hospital, Journal, MD, Patient, Polymerase chain reaction, Physician, Risk, Diagnosis, AI, PCR, Global Burden of Disease Study, Vaccine, Medical imaging, Medical device

TORONTO and PHILADELPHIA, March 28, 2023 /PRNewswire/ -- JMIR Publications published "Examining the Use of an Artificial Intelligence Model to Diagnose Influenza: Development and Validation Study" in the Journal of Medical Internet Research, which reported that it may be possible to diagnose influenza infection by applying deep learning to pharyngeal images given that influenza primarily infects the upper respiratory system.

Key Points: 
  • These authors aimed to develop a deep learning model to diagnose influenza infection using pharyngeal images and clinical information.
  • In the training stage, the authors developed a diagnostic prediction artificial intelligence (AI) model based on deep learning to predict polymerase chain reaction (PCR)-confirmed influenza from pharyngeal images and clinical information.
  • This process led to the development of the first AI model that can accurately diagnose influenza.
  • Dr Okiyama and the research team concluded in their JMIR Publications Research Article , "we developed the first AI-assisted diagnostic camera for influenza and prospectively validated its high performance.

AmoyDx® Pan Lung Cancer PCR Panel Approved in Japan as a Companion Diagnostic for selpercatinib RET fusion positive NSCLC

Retrieved on: 
Monday, March 27, 2023
KRAS, MHLW, Personalized medicine, BRAF, Lung cancer, Patient, Polymerase chain reaction, EGFR, ROS1, MET, Gene, PCR, RET, ALK, Health, NSCLC

The AmoyDx® PLC Panel is based on polymerase chain reaction (PCR) technology and can simultaneously evaluate the presence of activation alterations in 11 driver genes (EGFR/ ALK/ ROS1/ KRAS/ BRAF/ HER2/ RET/ MET/ NTRK1/ NTRK2/ NTRK3 genes) when all genes on the panel are approved as companion diagnostics.

Key Points: 
  • The AmoyDx® PLC Panel is based on polymerase chain reaction (PCR) technology and can simultaneously evaluate the presence of activation alterations in 11 driver genes (EGFR/ ALK/ ROS1/ KRAS/ BRAF/ HER2/ RET/ MET/ NTRK1/ NTRK2/ NTRK3 genes) when all genes on the panel are approved as companion diagnostics.
  • The AmoyDx® PLC Panel has received approval for the identification of activating alterations in seven driver genes (EGFR, ALK, ROS1, BRAF, MET exon 14 skipping, KRAS, and RET) for twelve (12) associated targeted therapies in NSCLC.
  • With its high sensitivity and short turnaround time, the AmoyDx® PLC Panel is expected to be an important clinical diagnostic in guiding treatment opportunities for NSCLC patients.
  • “With this approval, the AmoyDx® PLC Panel can now be used to identify RET fusion-positive NSCLC patients for treatment with selpercatinib, thereby expanding their therapeutic options.

GENOMADIX ANNOUNCES FDA CLEARANCE TO MARKET THE GENOMADIX CUBE CYP2C19 SYSTEM

Retrieved on: 
Wednesday, March 22, 2023
US Foods, CYP2C19, Allele, Stroke, CE marking, CYP450, Infection, PCR, Patient, Polymerase chain reaction, Physician, Medicine, Cardiology, FDA, Cube, Food, Medical device, Pharmaceutical industry

OTTAWA, ON, March 22, 2023 /PRNewswire/ - Genomadix, based in Ottawa, Canada, announced today the US Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing of its "Genomadix CubeTM CYP2C19 System" (Cube CYP2C19 test), an automated sample-to-result PCR test.

Key Points: 
  • OTTAWA, ON, March 22, 2023 /PRNewswire/ - Genomadix, based in Ottawa, Canada, announced today the US Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing of its "Genomadix CubeTM CYP2C19 System" (Cube CYP2C19 test), an automated sample-to-result PCR test.
  • The Cube CYP2C19 test can be used to aid clinicians in determining therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway.
  • Genomadix Cube CYP2C19 System identifies the CYP2C19 *2, *3, and *17 alleles, if present, directly from buccal swab in about an hour.
  • The Genomadix Cube CYP2C19 System is commercially distributed in Europe, as well as all countries recognizing the CE Mark (CE-IVD).

Marker Therapeutics Reports Fiscal Year 2022 Corporate and Financial Results

Retrieved on: 
Wednesday, March 22, 2023
Lymphoma, Pancreatic cancer, Marker, D, ARTEMIS, Data monitoring committee, Non-Hodgkin lymphoma, Food and Drug Administration, Clinical trial, Cell, HSCT, MRD, AML, Cancer, Patient, Polymerase chain reaction, Flow cytometry, Cytarabine, IND Culver Line, Research, FDA, Therapy, IND, Death, PCR, Hematopoietic stem cell transplantation, Food, Safety, Disease, Bone marrow, Pharmaceutical industry, Vaccine, Medical imaging, Nursing, Dentistry, Cryptocurrency

HOUSTON, March 22, 2023 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today reported fiscal year 2022 financial results and provided updates for its clinical development programs.

Key Points: 
  • Cash Position and Guidance: At December 31, 2022, Marker had cash and cash equivalents of $11.8 million.
  • R&D Expenses: Research and development expenses were $26.1 million for the year ended December 31, 2022, compared to $27.8 million for the year ended December 31, 2021.
  • G&A Expenses: General and administrative expenses were $12.8 million for the year ended December 31, 2022, compared to $12.9 million for the year ended December 31, 2021.
  • Net Loss: Marker reported a net loss of $29.9 million for the year ended December 31, 2022, compared to a net loss of $41.9 million for the year ended December 31, 2021.

Visby Medical™ Receives FDA Clearance and CLIA Waiver for Second Generation Sexual Health Test for Women

Retrieved on: 
Tuesday, March 14, 2023
SAN, Pharmacy, Patient, Korea Disease Control and Prevention Agency, Food, Visby, STI, Associate, Neisseria gonorrhoeae, PCR, Gonorrhea, Trichomonas vaginalis, Risk, Prevention, Polymerase chain reaction, Woman, Workflow, Education, Health, Chlamydia trachomatis, MD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Diagnosis, CLIA, POC, Stanford University, Pelvic inflammatory disease, Pharmaceutical industry, Birth control, Operation, Medicine, Neisseria, Trichomonas, Chlamydia

The Visby Medical Sexual Health test is a fast, polymerase chain reaction (PCR) diagnostic test for the detection of sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in women.

Key Points: 
  • The Visby Medical Sexual Health test is a fast, polymerase chain reaction (PCR) diagnostic test for the detection of sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in women.
  • The CLIA-waived, Sexual Health POC test provides accurate results in under 30 minutes, enabling clinicians to test, talk and accurately treat with confidence in a single patient visit.
  • "The Visby Sexual Health Test has been a game changer for us.
  • The Visby test is a win-win, helping fight antibiotic resistance as well as the spread of untreated infection, while empowering patients to engage health services with greater confidence."

QIAGEN and Servier Partner to Develop Companion Diagnostic for Acute Myeloid Leukemia (AML) Therapy Drug

Retrieved on: 
Thursday, March 9, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Medical Devices, US Food Sovereignty Alliance, Bone marrow, Polymerase chain reaction, PCR, NYSE, Blood, QGEN, Leukemia, Precision diagnostics, Biomarker, SRL Diagnostics, Helix, AML, IDH1, DSM-IV codes, Partnership, Patient, European, Disease, Medicine, QIAGEN, Nested polymerase chain reaction, NGS, Vaccine, Laboratoires Servier

The companion diagnostic will run on the QIAGEN Rotor-Gene Q MDx device, which is widely used by labs worldwide.

Key Points: 
  • The companion diagnostic will run on the QIAGEN Rotor-Gene Q MDx device, which is widely used by labs worldwide.
  • QIAGEN’s experienced regulatory teams will support clinical validation of the companion diagnostic and its approval in the US, the European Union and Japan.
  • QIAGEN is a pioneer in precision medicine and the leader in collaborating with pharmaceutical and biotechnology companies to develop companion diagnostics.
  • Furthermore, the company announced collaborations with Neuron23 and Helix to develop companion diagnostics in disease areas outside oncology.