MedRxiv

Lab Community "Extremely Concerned" About Patient Access to Testing If FDA Regulates Lab-Developed Tests

Retrieved on: 
Tuesday, March 5, 2024

"If labs cannot afford to comply with the proposed regulations, they will have to discontinue essential tests, and that harms patients."

Key Points: 
  • "If labs cannot afford to comply with the proposed regulations, they will have to discontinue essential tests, and that harms patients."
  • To better understand how clinical laboratorians perceive the proposed rule, ARUP Laboratories conducted a survey of the clinical laboratory community.
  • Most respondents identified themselves as lab managers, lab supervisors, lab directors, lab employees, medical directors, pathologists, physicians, clinicians, or PhD scientists.
  • Over a hundred thousand clinical laboratorians dedicate their professional lives to ensuring high-quality testing and patient care every day in the U.S.

PrognomiQ's Latest Research Demonstrates the Potential of its Multi-omics Liquid Biopsy Platform in Early-Stage Detection of Lung Cancer

Retrieved on: 
Monday, January 8, 2024

SAN MATEO, Calif., Jan. 8, 2024 /PRNewswire/ -- PrognomiQ – a healthcare company focused on harnessing the power of multi-omics data to transform the early detection, treatment selection and recurrence monitoring of cancer and other complex diseases – today announced promising results from the largest, deep multi-omics study conducted to date. The study, published online in medRxiv, focused on subjects at risk for lung cancer, demonstrating the power of multi-omics to deliver both high sensitivity and high specificity in the detection of early-stage lung cancer.

Key Points: 
  • The study, published online in medRxiv , focused on subjects at risk for lung cancer, demonstrating the power of multi-omics to deliver both high sensitivity and high specificity in the detection of early-stage lung cancer.
  • These encouraging data stem from a 2,513-subject case-control study which analyzed the molecular differences between the peripheral blood plasma of lung cancer subjects and non-cancer controls, many of whom were at high-risk for lung cancer.
  • Given the focus on high-risk populations in this study, the team focused on prioritizing high sensitivity, particularly for early-stage cancer.
  • These findings add to the body of research previously presented in 2023 on lung cancer detection at both the American College of Chest Physicians (CHEST) and the World Conference on Lung Cancer (WCLC), and on pancreatic cancer detection at the American Association of Cancer Research (AACR) annual conferences.

Cartesian Therapeutics Announces Positive Long-Term Follow-Up Data from Phase 2a Study of Lead mRNA Cell Therapy Candidate Descartes-08 in Patients with Myasthenia Gravis

Retrieved on: 
Monday, January 8, 2024

GAITHERSBURG, Md., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC), (“the Company”) a clinical-stage biotechnology company pioneering mRNA cell therapies for autoimmune diseases, today announced positive twelve-month follow-up data from its Phase 2a trial of Descartes-08 in patients with generalized myasthenia gravis (MG), a chronic autoimmune disorder that causes disabling muscle weakness and fatigue. The manuscript titled, “Twelve-Month Follow-Up of Patients With Generalized Myasthenia Gravis Receiving BCMA-Directed mRNA Cell Therapy,” has been submitted for peer-review and can be accessed on the online preprint server, medRxiv.

Key Points: 
  • The manuscript titled, “Twelve-Month Follow-Up of Patients With Generalized Myasthenia Gravis Receiving BCMA-Directed mRNA Cell Therapy,” has been submitted for peer-review and can be accessed on the online preprint server, medRxiv.
  • Descartes-08, Cartesian’s lead mRNA cell therapy candidate and a potential first-in-class mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T), is an autologous anti-B-cell maturation antigen (BCMA) mRNA CAR-T.
  • “Notably, most patients maintained robust, clinically meaningful improvements across all four standard MG severity scores approximately 10 months after the last infusion.
  • Enrollment is ongoing in a Phase 2b randomized, double-blind, placebo-controlled trial (NCT04146051) in patients with MG. Topline results are expected in mid-2024.

Researchers behind Netflix's new 'You Are What You Eat: A Twin Experiment' study give additional context to pro-vegan findings

Retrieved on: 
Friday, January 5, 2024

These algorithms use DNA methylation to quantify biological age, and many show association to disease risk and overall health, thus making them informative clinical tools to assess aging and health.

Key Points: 
  • These algorithms use DNA methylation to quantify biological age, and many show association to disease risk and overall health, thus making them informative clinical tools to assess aging and health.
  • "These groundbreaking findings underscore the potential of epigenetic clocks as real-time biomarkers, offering valuable insights into physiological changes, exemplified by weight loss in this study," explains Dr. Lucia Aronica of Stanford University.
  • "However, it is crucial to stress that a vegan diet lacks essential nutrients for optimal epigenetic processes.
  • The discrepancy between the seemingly pro-vegan results, and long term impacts to epigenetic, biological aging rests in the study's short-term nature, spanning only two months for twin participants.

Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics’ ARCT-154, the First Self-Amplifying mRNA Vaccine Approved for COVID in Adults

Retrieved on: 
Tuesday, November 28, 2023

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older.

Key Points: 
  • Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older.
  • Initial study results have been published in MedRxiv and are expected to be published in a peer-reviewed journal by the end of the year.
  • "This approval for the sa-mRNA COVID-19 vaccine is a major achievement, and we are excited to embark on future endeavors that utilize our innovative sa-mRNA vaccine platform alongside our global exclusive partner, CSL."
  • CSL's vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, partnered exclusively with Meiji Seika Pharma for distribution of the sa-mRNA COVID vaccine, ARCT 154, in Japan.

Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the first Self-Amplifying mRNA vaccine approved for COVID in adults

Retrieved on: 
Tuesday, November 28, 2023

KING OF PRUSSIA, Pa. and SAN DIEGO, Nov. 27, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older. 

Key Points: 
  • With the approval of ARCT-154, CSL now offers an even more comprehensive portfolio of innovative vaccines that combat respiratory viral diseases.
  • "We are committed to working with health authorities around the world to ensure this important vaccine technology will be available to people at risk for COVID-19."
  • "This approval for the sa-mRNA COVID-19 vaccine is a major achievement, and we are excited to embark on future endeavors that utilize our innovative sa-mRNA vaccine platform alongside our global exclusive partner, CSL."
  • CSL's vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, partnered exclusively with Meiji Seika Pharma for distribution of the sa-mRNA COVID vaccine, ARCT 154, in Japan.

Lucid Diagnostics Announces PREVENT and PREVENT-FF Registries of EsoGuard® Esophageal Precancer Detection

Retrieved on: 
Tuesday, October 31, 2023

NEW YORK, Oct. 31, 2023 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), today announced two longitudinal clinical registries which are collecting real-world clinical utility and clinical validity data on EsoGuard® Esophageal DNA testing for the detection of esophageal precancer. The Prospective REView of Esophageal Precancer DetectioN in AT-Risk Patients (PREVENT) Registry collects data on EsoGuard testing in the general at-risk population, while the PREVENT-FF Registry focuses exclusively on at-risk firefighters. The Company released positive clinical utility data from an initial combined analysis of patients from both registries.

Key Points: 
  • The Prospective REView of Esophageal Precancer DetectioN in AT-Risk Patients (PREVENT) Registry collects data on EsoGuard testing in the general at-risk population, while the PREVENT-FF Registry focuses exclusively on at-risk firefighters.
  • The PREVENT Registry prospectively enrolls patients with well-established esophageal precancer risk-factors referred by a physician to Lucid for EsoGuard testing.
  • Lucid clinical personnel perform esophageal cell collection using the EsoCheck® Cell Collection Device and Lucid's CLIA-certified laboratory then performs the EsoGuard test on the sample.
  • The PREVENT-FF Registry prospectively enrolls firefighters with additional esophageal precancer risk factors referred for EsoGuard testing who participate in one of Lucid's #CheckYourFoodTube Precancer Testing Events.

Elixirgen Therapeutics Announces Promising Phase 1/2 Data on EXG-5003, a Controllable Self-Replicating RNA (c-srRNA) Vaccine Against SARS-CoV-2

Retrieved on: 
Monday, October 16, 2023

BALTIMORE, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Elixirgen Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery, development and commercialization of therapies using its mRNA platforms, today announced promising data from a Phase 1/2 trial (NCT04863131) evaluating EXG-5003, a SARS-CoV-2 vaccine developed with the Company’s temperature controllable self-replicating RNA (c-srRNA) technology. The data, published on medRxiv, demonstrate no safety concerns with EXG-5003 and induction of cellular (T cell-mediated) immunity. With clinical evidence that the c-srRNA platform is safe and can produce a T cell-mediated response, the Company is exploring its potential for the development of vaccines, cell therapies and immunotherapies for several indications.

Key Points: 
  • The data, published on medRxiv , demonstrate no safety concerns with EXG-5003 and induction of cellular (T cell-mediated) immunity.
  • The results from this trial suggest a priming effect by EXG-5003 on the long-term cellular immunity of approved SARS-CoV-2 mRNA vaccines.
  • This allows for the vaccine to be delivered intradermally, which is a method that’s been shown to induce strong T cell-mediated immunity.
  • Data suggest a priming effect by EXG-5003 on the long-term cellular immunity of approved SARS-CoV-2 mRNA vaccines.

Lucid Diagnostics Releases Positive Data Demonstrating Clinical Utility of EsoGuard® Esophageal Precancer Detection in Fire Fighters

Retrieved on: 
Wednesday, September 6, 2023

NEW YORK, Sept. 6, 2023 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ( "PAVmed"), today announced it has released positive data from a retrospective analysis demonstrating real-world clinical utility of  EsoGuard® Esophageal DNA testing for the detection of esophageal precancer in a large cohort of fire fighters.

Key Points: 
  • The release of these data closely aligns with and strongly supports recently proposed federal legislation seeking to fund guaranteed firefighter access to early detection tests such as EsoGuard.
  • "Such clinical utility data, along with claims history, has been a key gating item for us to engage payors to secure in-network EsoGuard coverage.
  • 391 SAFD fire fighters who were deemed by a physician to be at-risk for esophageal precancer participated in the event.
  • EsoGuard provides an unprecedented precancer sensitivity of over 80 percent, while no other single or multi-cancer early detection test, blood-based or otherwise, provides any sensitivity in detecting esophageal precancer."

Faron Reports Half-Year Financial Results, January 1 – June 30, 2023

Retrieved on: 
Tuesday, August 29, 2023

TURKU, Finland and BOSTON, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces unaudited half-year financial results for January 1 to June 30, 2023 (the "period").

Key Points: 
  • Mr. Leopoldo Zambeletti stepped down from the Board to assume a business development consulting role at Faron.
  • TURKU, Finland and BOSTON, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces unaudited half-year financial results for January 1 to June 30, 2023 (the "period").
  • "I am extremely proud of the progress we made in the first half of 2023,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron.
  • On June 30, 2023, the Company had outstanding borrowings of EUR 9.8 million under a loan facility with IPF Partners which is subject to financial covenants.