RT-PCR

Invivyd Announces Interim Exploratory Data on VYD222 from Ongoing CANOPY Clinical Trial

Retrieved on: 
Friday, March 22, 2024
Science, Risk, COVID-19, Patient, SARS-CoV-2, RT-PCR, Clinical trial, Vaccination, Safety, Collection, Vaccine

Exploratory data such as provided in today’s update are important for broad reflection as they represent some of the first data from a clinical trial conducted with a monoclonal antibody in a population that has acquired prior immune exposure from either vaccination or natural infection.

Key Points: 
  • Exploratory data such as provided in today’s update are important for broad reflection as they represent some of the first data from a clinical trial conducted with a monoclonal antibody in a population that has acquired prior immune exposure from either vaccination or natural infection.
  • Symptomatic COVID-19 event collection in the CANOPY clinical trial is a secondary exploratory endpoint designed to allow Invivyd to contemplate further discovery and development work only.
  • The CANOPY clinical trial enrolled participants in two cohorts.
  • Invivyd is now providing an update on the clinical cases of confirmed symptomatic COVID-19 through Day 90.

Zymo Research Receives 510(k) Clearance for its Saliva Self-Collection & Transport Device

Retrieved on: 
Wednesday, November 15, 2023
Saliva, SARS-CoV-2, IVD, COVID-19, Safety, RT-PCR, Food, Temperature, Research, COVID-19 testing, RNA, Transport, FDA, ITM, Medical device, Vaccine

IRVINE, Calif., Nov. 15, 2023 /PRNewswire/ -- Zymo Research announced today that the U.S. Food and Drug Administration (FDA) has cleared its DNA/RNA Shield™ SafeCollect™ Saliva Collection Kit as a Class II medical device for microbial nucleic acid storage and stabilization.

Key Points: 
  • IRVINE, Calif., Nov. 15, 2023 /PRNewswire/ -- Zymo Research announced today that the U.S. Food and Drug Administration (FDA) has cleared its DNA/RNA Shield™ SafeCollect™ Saliva Collection Kit as a Class II medical device for microbial nucleic acid storage and stabilization.
  • The FDA's 510(k) clearance allows the product to be used as an In-vitro Diagnostic (IVD) device for saliva collection and transport.
  • Specifically granted for COVID-19 testing, the SafeCollect™ Saliva Collection Kit utilizes DNA/RNA Shield™ - the first FDA-cleared inactivating transport medium (ITM) to demonstrate inactivation and preservation of the SARS-CoV-2 RNA virus.
  • "This 510(k) clearance highlights the FDA's initiative in bringing enabling technologies to the maturing molecular diagnostic space."

Molecular Designs releases their new Candida auris PCR Simplicity Panel™

Retrieved on: 
Thursday, November 9, 2023
Simplicity, Research, GMP, Candida auris, Immunodeficiency, Patient, RT-PCR, Molecular design software, PCR, ISO, Laboratory, Workflow, Infection, Health care, Hospital, Vaccine, Candida

BIRMINGHAM, Ala., Nov. 9, 2023 /PRNewswire/ -- Molecular Designs, a leading provider of molecular infectious disease assays, has released its latest product, the Candida auris Simplicity Panel™.

Key Points: 
  • BIRMINGHAM, Ala., Nov. 9, 2023 /PRNewswire/ -- Molecular Designs, a leading provider of molecular infectious disease assays, has released its latest product, the Candida auris Simplicity Panel™.
  • It aims to improve the workflow for clinical and research laboratories with the advances they've achieved with their Simplicity Panel ™ technology.
  • The Candida auris Simplicity Panel™ is an in-vitro multiplex real-time polymerase chain reaction (RT-PCR) assay for qualitatively identifying this fungal pathogen.
  • In so doing, Molecular Designs aims to help laboratories respond to the challenge posed by Candida auris.

Peer-Reviewed Independent Study Published in Microbiology Spectrum Finds Cue Health’s Molecular COVID-19 Test is as Accurate as a Lab-Based PCR Test

Retrieved on: 
Wednesday, October 4, 2023
Biotechnology, Health, COVID-19, Clinical Trials, Infection, Microbiology, De novo, RNS, Landing slot, ISO, American Society for Microbiology, RT-PCR, FH, COVID-19 testing, Trial of the century, Viral load, Immunodeficiency, FDA, RT, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Cue, PCR, Food, Pharmaceutical industry, Nursing, Vaccine, Microbiology Spectrum

The study, published in Microbiology Spectrum, a journal produced by the American Society for Microbiology, presents findings from a head-to-head comparison of the Cue COVID-19 test against lab-based RT-PCR on paired samples from 3,037 individuals.

Key Points: 
  • The study, published in Microbiology Spectrum, a journal produced by the American Society for Microbiology, presents findings from a head-to-head comparison of the Cue COVID-19 test against lab-based RT-PCR on paired samples from 3,037 individuals.
  • The findings from paired testing revealed a 99.4% match between results from Cue’s test and the reference PCR tests with 100% clinical sensitivity to detect positive cases, yielding no false negatives.
  • To further expand its diagnostic test menu for at-home and point-of-care use, Cue has made a number of other submissions with the FDA.
  • Cue did not provide funding or any other support of the study.

Introducing Anbio's Molecular RT-PCR Solution: Empowering Precision Diagnostics Across Diverse Clinical Applications

Retrieved on: 
Tuesday, July 25, 2023
MDX, Infection, RT-PCR, Hospital, RT, Fungal infection, Toxicity, PCR, Virology, Medical imaging

Anbio molecular diagnostic test menu spans multiple clinical applications including healthcare-associated infections, critical infectious disease, sexual health, virology, pharmacogenomics, and oncology.

Key Points: 
  • Anbio molecular diagnostic test menu spans multiple clinical applications including healthcare-associated infections, critical infectious disease, sexual health, virology, pharmacogenomics, and oncology.
  • Anbio molecular diagnostic tests can be employed in institutions of any size, from small medical clinics to high-volume reference laboratories and hospitals, to access the speed and accuracy of molecular diagnostics.
  • Our approach to molecular diagnostics (MDx) simplifies the challenges associated with RT-PCR, catering to the requirements of both novice and experienced users in quantitative reverse transcriptase PCR (qRT-PCR).
  • To learn more about our RT-PCR solution and Anbio's range of innovative diagnostic solutions, please visit www.anbio.com .

Gencurix Obtains Approval for Companion Diagnostic of Digital PCR-based EGFR Mutation Test

Retrieved on: 
Wednesday, June 14, 2023
KRAS, CE, AACR, Takeda, Severance Hospital, ESR1, NGS, RT-PCR, Cancer, Business, BRAF, Janssen, Mutation, Research, PIK3CA, Certification, Strategy, MRD, Plasma, Korean Ministry of Culture, Bio-Rad Laboratories, Hospital, Acquisition, Patient, European, EGFR, Colorectal cancer, IVD, Samsung Medical Center, Amivantamab, POLE, Recurrence, PCR, Mobocertinib, Medical device, NSCLC, Food

SEOUL, South Korea, June 13, 2023 /PRNewswire/ -- Gencurix , a leading cancer molecular diagnostics company, has obtained approval from the Korean Ministry of Food and Drug Safety for its Droplex EGFR Mutation Test v2.

Key Points: 
  • SEOUL, South Korea, June 13, 2023 /PRNewswire/ -- Gencurix , a leading cancer molecular diagnostics company, has obtained approval from the Korean Ministry of Food and Drug Safety for its Droplex EGFR Mutation Test v2.
  • This product is a companion diagnostic test designed to detect EGFR mutations commonly found in NSCLC patients and guide the selection of appropriate targeted anticancer therapies based on the test results.
  • Compared to existing EGFR mutation tests using RT-PCR, this product demonstrates significantly higher sensitivity.
  • This is the second EGFR mutation test for which Gencurix has obtained approval.

Wave Life Sciences Provides Positive Update on Proof-of-Concept Study for WVE-N531 in Duchenne Muscular Dystrophy

Retrieved on: 
Monday, December 19, 2022
Clinical trial, Duchenne muscular dystrophy, MD, DMD, COVID-19, Dystrophin, MBA, Degenerative disease, PN, Pharmacology, Half-life, Plasma, BLQ, Webcast, Adverse, Human, RNA editing, Doctor of Philosophy, RNA, RT-PCR, Q&A, Vaccine, Wave

High muscle concentrations of WVE-N531 and exon skipping were observed six weeks after initiating biweekly multidosing at 10 mg/kg, achieving proof-of-concept in the study.

Key Points: 
  • High muscle concentrations of WVE-N531 and exon skipping were observed six weeks after initiating biweekly multidosing at 10 mg/kg, achieving proof-of-concept in the study.
  • “These data provide early evidence that WVE-N531 is working as intended, leading to substantial exon skipping after just three consecutive doses.
  • This is the earliest timepoint at which exon skipping has been reported in a clinical trial of boys with DMD,” said Anne-Marie Li-Kwai-Cheung, Chief Development Officer of Wave Life Sciences.
  • Following the live event, an archived version of the webcast will be available on the Wave Life Sciences website.

IDENTIFYSENSORS BIOLOGICS REACHES BREAKTHROUGH SENSITIVITY LEVELS WITH NEW DIGITAL DIAGNOSTICS PLATFORM

Retrieved on: 
Wednesday, December 7, 2022
Genome, Stomach, HIV, RT-PCR, Lyme disease, Mobile, Rotavirus, Hepatitis, Patient, COVID, Gonorrhea, Research, Digital, PCR, Food, FDA, Yellow fever, COVID-19, RSV, Infection, MRSA, Vaccine, Pharmaceutical industry, Adenoviridae, Herpes simplex, Chlamydia, Dengue fever, Norovirus

CLEVELAND, Dec. 7, 2022 /PRNewswire/ -- IdentifySensors Biologics has completed preliminary clinical tests of positive COVID-19 samples using new graphene digital sensors, which demonstrate level-of-detection capabilities four times more sensitive than PCR tests.

Key Points: 
  • The samples were then diluted to the preliminary limit of detection of 200 copies per milliliter and retested using Check4.
  • The research demonstrates that infections, such as COVID, RSV and influenza, can soon be diagnosed well before patients develop symptoms, said IdentifySensors Biologics Cofounder and CEO Gregory Hummer M.D.
  • Digital graphene sensors inside the cartridges target conserved regions of the genome allowing for high sensitivity and specificity.
  • The company's technology has expanded into multiple industries and applications, such as pathogen diagnostics and testing for food contamination.

Exact Sciences Highlights the Impact of Precision Oncology Portfolio on Breast Cancer Treatment with 10 New Data Presentations at SABCS® 2022

Retrieved on: 
Wednesday, December 7, 2022
Recurrence, Poster, MDM, Breast cancer, ESR1, National Cancer Institute, Research, Cancer, Woman, Guideline, Database, Gene, Risk, Precision, Physician, Prognosis, Trial, Ageing, Stemmer, Treatment, Lymph, BRCA2, Genomic Health, White, NCI, Oncotype (Denmark), Security (finance), Exact Sciences (company), RT-PCR, MD, Diagnosis, DNA, The New England Journal of Medicine, Exact sciences, Radiation, MRD, RNA, Mutation, Breast, Electric Bond and Share Company v. Securities and Exchange Commission, CT, Patient, Annual report, ER, News, Intron, Health, Mount Sinai Health System, Birth control, Pharmaceutical industry, Medical imaging, Vaccine, Silviculture, Wood drying

"The breadth of evidence presented at SABCS 2022 showcases Exact Sciences' growing Precision Oncology portfolio and commitment to personalizing cancer care and potentially enabling better outcomes at every step," said Rick Baehner, M.D., chief medical officer of Precision Oncology.

Key Points: 
  • "The breadth of evidence presented at SABCS 2022 showcases Exact Sciences' growing Precision Oncology portfolio and commitment to personalizing cancer care and potentially enabling better outcomes at every step," said Rick Baehner, M.D., chief medical officer of Precision Oncology.
  • In breast cancer, the Oncotype DX Breast Recurrence Scoretest is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer.
  • The Oncotype DX test is recognized as a standard of care and is included in all major breast cancer treatment guidelines.
  • For more information, please visit the company's website at exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.

Exact Sciences Highlights the Impact of Precision Oncology Portfolio on Breast Cancer Treatment with 10 New Data Presentations at SABCS® 2022

Retrieved on: 
Tuesday, December 6, 2022
Recurrence, Poster, MDM, Breast cancer, ESR1, National Cancer Institute, Research, Cancer, Woman, Guideline, Database, Gene, Risk, Precision, Physician, Prognosis, Trial, Ageing, Stemmer, Treatment, Lymph, BRCA2, Genomic Health, White, NCI, Oncotype (Denmark), Security (finance), Exact Sciences (company), RT-PCR, MD, Diagnosis, DNA, The New England Journal of Medicine, Exact sciences, Radiation, MRD, RNA, Mutation, Breast, Electric Bond and Share Company v. Securities and Exchange Commission, CT, Patient, Annual report, ER, News, Intron, Health, Mount Sinai Health System, Birth control, Pharmaceutical industry, Medical imaging, Vaccine, Silviculture, Wood drying

"The breadth of evidence presented at SABCS 2022 showcases Exact Sciences' growing Precision Oncology portfolio and commitment to personalizing cancer care and potentially enabling better outcomes at every step," said Rick Baehner, M.D., chief medical officer of Precision Oncology.

Key Points: 
  • "The breadth of evidence presented at SABCS 2022 showcases Exact Sciences' growing Precision Oncology portfolio and commitment to personalizing cancer care and potentially enabling better outcomes at every step," said Rick Baehner, M.D., chief medical officer of Precision Oncology.
  • In breast cancer, the Oncotype DX Breast Recurrence Scoretest is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer.
  • The Oncotype DX test is recognized as a standard of care and is included in all major breast cancer treatment guidelines.
  • For more information, please visit the company's website at exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.