Clinical Laboratory

Association for Diagnostics & Laboratory Medicine (formerly AACC) survey of clinical labs finds that FDA's proposed laboratory developed tests rule would hinder pediatric care

Retrieved on: 
Tuesday, April 9, 2024
Hospital, Diagnosis, Disability, Risk, AACC, CLIA, Clinical Laboratory, Brain damage, Medical laboratory, Medicare, FDA, CMS, Health, Legislation, Food, Pharmaceutical industry

View the full survey results here: https://www.myadlm.org/lp/ldts-survey

Key Points: 
  • View the full survey results here: https://www.myadlm.org/lp/ldts-survey
    Laboratory developed tests are tests that clinical labs create and perform in-house to meet the needs of their local patient populations.
  • These tests are currently regulated by the Centers for Medicare & Medicaid Services (CMS) via the Clinical Laboratory Improvement Amendments (CLIA).
  • In the first week, 140 U.S. clinical labs responded to the survey, 87% of which said they perform laboratory developed tests.
  • ADLM's survey findings underscore the fact that placing these tests under additional FDA oversight would undermine care for children across the U.S."

The Association for Diagnostics & Laboratory Medicine (formerly AACC) recommends to Congress that the regulation and modernization of clinical tests be managed under the auspices of the Clinical Laboratory Improvement Advisory Committee, CMS, and Congress

Retrieved on: 
Tuesday, April 2, 2024
American Medical Association, Education, Congress, Labour, Ranking, Committee, AACC, Communication, Diagnosis, Children's Hospital Association, CLIA, Clinical Laboratory, Medical laboratory, Medicare, FDA, CMS, Health, Food, Medical device

Specifically, ADLM supports modernizing the Clinical Laboratory Improvement Amendments (CLIA), through which the Centers for Medicare & Medicaid Services (CMS) regulates laboratory developed tests.

Key Points: 
  • Specifically, ADLM supports modernizing the Clinical Laboratory Improvement Amendments (CLIA), through which the Centers for Medicare & Medicaid Services (CMS) regulates laboratory developed tests.
  • Additional FDA oversight would be duplicative, costly — and could force many clinical labs to stop performing these essential tests.
  • "As an alternative, ADLM suggests updating CLIA's standards through the Clinical Laboratory Improvement Advisory Committee (CLIAC).
  • "Once changes are made through the regulatory process, ADLM proposes that Congress evaluate and update the underlying statute that governs CLIA.

Juntendo University Broadens the Scope of Mitochondrial Disease Testing

Retrieved on: 
Monday, February 12, 2024
Mitochondrial disease, Pediatrics, Medical research, Juntendo University, Clinical Laboratory, Mitochondrion, Cardiomyopathy, Hearing loss, RNA, Adolescence, Adenosine, Genetic testing, ATP, Disease, Insurance, Kidney, Diagnosis, Development, Research, DNA, Seizure, Pharmaceutical industry

TOKYO, Feb. 12, 2024 /PRNewswire/ -- Mitochondrial disease occurs when malfunctioning mitochondria cannot sustain the production of adenosine triphosphate (ATP)—the energy currency of life—in the inner mitochondrial membrane. The loss of this vital molecule has far-reaching consequences that affect various organ systems and can cause psychiatric symptoms, cardiomyopathy, seizures, kidney and liver dysfunction, and hearing loss.

Key Points: 
  • The Intractable Disease Research Center at Juntendo University will conduct broader analyses of mitochondrial genetic data to confirm genetic diagnosis.
  • Unfortunately, mitochondrial disease is the most common congenital metabolic condition, with one case detected for every 5000 live births.
  • In terms of testing, Juntendo University screens many babies diagnosed with mitochondrial disease each year.
  • In this regard, Prof. Murayama's team commenced mitochondrial disease outpatient care at Juntendo Medical Center's Pediatric and Adolescent Department in July 2023.

Celerion Achieves Milestone With CLIA Certification for Its Bioanalytical Laboratory, Expanding Capabilities in Clinical Trials and Diagnostic Testing

Retrieved on: 
Tuesday, February 6, 2024
Health, Clinical Trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, CMS, Accreditation, Clinical trial, Certification, Clinical Laboratory, Neutralizing antibody, Diagnosis, CLIA, Pharmaceutical industry

Celerion , a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) certification for its state-of-the-art bioanalytical laboratory located in Lincoln, Nebraska.

Key Points: 
  • Celerion , a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) certification for its state-of-the-art bioanalytical laboratory located in Lincoln, Nebraska.
  • Celerion’s clinical laboratories, including their Lincoln site, have been CLIA-certified and CAP-accredited for over 25 years, which helped facilitate the CLIA certification of the laboratory.
  • The CLIA certification is a testament to Celerion’s adherence to the highest standards of laboratory quality and competence.
  • With this certification, Celerion’s bioanalytical laboratory is now able to conduct lab-developed tests in specialized areas such as diagnostic immunology.

bioAffinity Technologies In The News

Retrieved on: 
Tuesday, January 30, 2024
Technology, Surgery, Medical Devices, General Health, Science, Genetics, Clinical Trials, FDA, Biotechnology, Health, Health Technology, Research, Software, Other Health, Radiology, Pharmaceutical, Oncology, Intelligence, Lung cancer, College, Therapy, Clinical Laboratory, Sputum, CLIA, BIAF, Laboratory, Artificial intelligence, TCPP, Patent, Lung, Accreditation, CAP, Porphyrin, Cancer, Malignancy, Medical imaging

bioAffinity Technologies , Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer and lung disease, provides a summary of recent Company news.

Key Points: 
  • bioAffinity Technologies , Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer and lung disease, provides a summary of recent Company news.
  • Precision Pathology Laboratory Services (PPLS), a bioAffinity Technologies company, successfully passed the rigorous biannual inspection required for College of American Pathologists (CAP) accreditation.
  • ScienceSoft , which provides IT consulting and software development services to more than 1,200 clients around the globe, recently published a case study of its work with bioAffinity Technologies.
  • More than 1,000 people registered for Webull Corporate Connect’s recent investment webinar that featured bioAffinity Technologies ’ President and CEO Maria Zannes and two other healthcare executives.

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
Biology, RNA, Conference, Genotype, AACR, Proteomics, Risk, Eastern Time Zone, Death, Collection, Research, Lung cancer, Pacific Ocean, DNA, SAN, CLIA, Recurrence, Clinical Laboratory, Cancer, Lipid, Pancreatic cancer, Biomarker, American College, Phenotype, MedRxiv, WCLC, Medical imaging

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.

Savara Introduces aPAP ClearPath™, a GM-CSF Autoantibody Blood Test to Detect Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Retrieved on: 
Thursday, December 21, 2023
Medical Supplies, Medical Devices, Health, Clinical Trials, Pharmaceutical, Biotechnology, Associate, Autoantibody, Division, Physician, GM, Critical Care Medicine (journal), Chair, Prevalence, Disease, University of Florida, GM-CSF, CLIA, Clinical Laboratory, Serum, University, Patient, Diagnosis, PAP, APAP, Inc., Pharmaceutical industry

The aPAP ClearPath™ test is a highly sensitive and specific quantitative immunoassay designed to detect aPAP GM-CSF autoantibodies in human serum.

Key Points: 
  • The aPAP ClearPath™ test is a highly sensitive and specific quantitative immunoassay designed to detect aPAP GM-CSF autoantibodies in human serum.
  • “I congratulate Savara for making this simple test broadly available for physicians in the U.S.”
    Only a physician or healthcare provider can make a diagnosis of aPAP.
  • To learn more about aPAP ClearPath™, the importance of early testing for aPAP, and to order a test kit, please visit www.apapclearpath.com .
  • The Company expects to roll out a healthcare provider disease awareness campaign and GM-CSF autoantibody blood test in Europe next year.

bioAffinity Technologies Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 14, 2023
Oncology, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Sale, Lung, BIAF, Acquisition, Research, Exercise, CLIA, CAP, College, CPT, Patient, Clinical Laboratory, LDT, American Medical Association, Marketing, CMS, Lung cancer, Histology, Growth, Medicare, Gastric lavage, DOD, Physician, Military personnel, Observational study, Pharmaceutical industry, Medicaid

bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other diseases of the lung, today reported financial results for the three and nine months ended Sept. 30, 2023, and provided a business update.

Key Points: 
  • bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other diseases of the lung, today reported financial results for the three and nine months ended Sept. 30, 2023, and provided a business update.
  • CMS is expected to finalize the 2024 payment for CyPath® Lung in November 2023 with an effective date of Jan. 1, 2024.
  • Clinical development expenses were $106,422 for the third quarter of 2023, compared with $60,941 for the third quarter of 2022.
  • Over the next 12 months (fourth quarter 2023 to third quarter 2024), the Company expects to generate between $8.4 and $9.0 million in net revenues.

Allelica launches the Allelica Precision Server, an on-premises solution for clinical bioinformatics analyses

Retrieved on: 
Friday, November 3, 2023
PDF, APS, PRS, Laboratory, American Society of Human Genetics, CSO, Clinical Laboratory, Genetics, Society, CLIA, Medicine, Human genetics, Medical device, Internet service provider

NEW YORK, Nov. 3, 2023 /PRNewswire/ -- Allelica, the leading provider of software tools for clinical bioinformatics, announced the launch of its latest innovation, the Allelica Precision Server (APS). APS revolutionizes the way medical laboratories approach clinical bioinformatics analyses, streamlining polygenic risk score (PRS), pharmacogenomics (PGx), and carrier screening analyses securely and efficiently within their own environments.

Key Points: 
  • Allelica announces the release of the Allelica Precision Server for CLIA-compliant, on-premises analysis and clinical reporting of polygenic risk score, pharmacogenomics and carrier screening
    NEW YORK, Nov. 3, 2023 /PRNewswire/ -- Allelica, the leading provider of software tools for clinical bioinformatics, announced the launch of its latest innovation, the Allelica Precision Server (APS).
  • APS revolutionizes the way medical laboratories approach clinical bioinformatics analyses, streamlining polygenic risk score (PRS), pharmacogenomics (PGx), and carrier screening analyses securely and efficiently within their own environments.
  • APS is designed to support the development of clinical tests that meet the Clinical Laboratory Improvement Amendments (CLIA) standards, ensuring the accuracy and reliability of results.
  • For clinical laboratories developing these tests, it's crucial to perform validation procedures using the same software tools which will be used in production.

Neural Therapeutics Announces Board of Directors Appointments and IP Development Agreement with Validity Labs

Retrieved on: 
Tuesday, October 3, 2023
Aurora, CGS, Medical Affairs Bureau, CFA, Diabetes, Medicine, Doctor of Philosophy, BBA, Professor, Agreement, Science, Patent, University, Cardiovascular disease, Research, Certification, DEA, Geisel School of Medicine, Ernst, Ernst & Young, Drug Enforcement Administration, Metro, Grenadines, Clinical Laboratory, United States Patent and Trademark Office, Cancer, IP, CFO, Therapy, Pharmacy, Partnership, Drug development, Internet of things, General insurance, Canada Research Chair, Canada Research Chair in International Political Economy, Wilfrid Laurier University, Baylor College of Medicine, Pharmaceutical industry, Medical device, Nervous system, Molecular medicine

The Company is also pleased to announce that it has entered into IP development agreement ("Agreement") with Validity Laboratory Services LLC ("Validity Labs").

Key Points: 
  • The Company is also pleased to announce that it has entered into IP development agreement ("Agreement") with Validity Laboratory Services LLC ("Validity Labs").
  • Following these appointments, the board of directors of Neural is comprised of Ian Campbell, John Durfy, Colin McLelland, Dr. Kelly Narine and Dr. Jason Dyck.
  • Ian Campbell, CEO of Neural commented: "The expansion of our partnership with CGS and Validity Labs allows us to foster collaborative relationships with Validity Labs and leverage their extensive capabilities and expertise.
  • In connection with the Agreement entered between Neural and Validity Labs, Neural issued 500,000 common shares in the capital of Neural ("Neural Shares"), which was included in debt settlement issuance as outlined in Neural press release dated October 2, 2023.