CLIA

Mirvie Becomes First RNA-Based Pregnancy Health-Focused Company to Receive Clinical Laboratory Improvement Amendments (CLIA) Certification

Retrieved on: 
Tuesday, September 26, 2023
Health, Consumer, Hospitals, Health Technology, Genetics, Baby, Maternity, Biotechnology, Pregnancy, CMS, Obstetrics, Centers for Medicare & Medicaid Services, Clinical Laboratory, Bill & Melinda Gates Foundation, Parent, RNA, Certification, Medicare, CLIA, American Journal, Risk, Gynaecology, Quality control, Biology, Entrepreneurship, Research, FDA, Pregnancy Outcome Prediction study, Pharmaceutical industry, Ephraim Mirvis, Nature

Mirvie , a pioneer in predicting unexpected pregnancy complications, today announced its South San Francisco-based laboratory has been certified by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity clinical testing.

Key Points: 
  • Mirvie , a pioneer in predicting unexpected pregnancy complications, today announced its South San Francisco-based laboratory has been certified by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity clinical testing.
  • “We are extremely proud to have received CLIA certification, which marks a crucial milestone in our journey towards commercializing the Mirvie RNA platform,” said Maneesh Jain, Co-Founder and CEO of Mirvie.
  • “Our recent grant from the Bill and Melinda Gates Foundation, coupled with our FDA Breakthrough Device Designation last year and now CLIA certification, has given us significant momentum.
  • Mirvie predicts life-threatening complications months in advance using a patented RNA platform to reveal each pregnancy’s underlying biology.

Recent Nature publications highlight the groundbreaking performance of RareCyte's Orion Spatial Biology platform

Retrieved on: 
Tuesday, September 26, 2023
University, CRC, Progression-free survival, MSS, Survival, Liquid biopsy, NewYork-Presbyterian Hospital, Research, Harvard Medical School, CLIA, Massachusetts General Hospital, Professor, Publication, Patient, Colorectal cancer, Weill Cornell Medicine, Neoplasm, Hospital, Oncogene, University of Sydney, Recurrence, Neoadjuvant therapy, Medical imaging, Nature, Nature Cancer

SEATTLE, Sept. 26, 2023 /PRNewswire/ -- In the exciting, growing field of Spatial Biology, the Orion platform from RareCyte has emerged as the platform of choice across biomarker discovery, translational and clinical research.

Key Points: 
  • SEATTLE, Sept. 26, 2023 /PRNewswire/ -- In the exciting, growing field of Spatial Biology, the Orion platform from RareCyte has emerged as the platform of choice across biomarker discovery, translational and clinical research.
  • Recent publications of pioneering findings in Nature journals, by leading translational and clinical institutions using the Orion multiplex imaging platform, demonstrate improved methods to help predict patient outcomes and to track the efficacy of novel therapies designed to shrink tumors ahead of resection.
  • Automated generation and ranking of spatial biomarkers revealed novel markers that are highly predictive of progression-free survival.
  • The global adoption of Orion for spatial biology research is a continuation of RareCyte's legacy of supporting important studies across all therapeutic areas, with a special focus on oncology.

QuidelOrtho Receives CLIA Waiver for Sofia® 2 SARS Antigen+ FIA

Retrieved on: 
Thursday, September 21, 2023
FDA, Health, Infectious Diseases, COVID-19, Pharmaceutical, Biotechnology, De novo, FIA, Transfusion medicine, SARS-CoV-2, SARS, QuidelOrtho, Coinfection, CLIA, Risk, WALK, READ, Genetically modified bacteria, Peter Hancock (professor), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Virus, Food, Disease, Vaccine

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted CLIA Waiver from the U.S. Food and Drug Administration (FDA), applying to its new Sofia® 2 SARS Antigen+ FIA.

Key Points: 
  • QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted CLIA Waiver from the U.S. Food and Drug Administration (FDA), applying to its new Sofia® 2 SARS Antigen+ FIA.
  • The Sofia 2 SARS Antigen+ FIA is the first rapid antigen test that detects COVID-19 to be awarded FDA market clearance through the FDA’s De Novo process and is now the first rapid antigen test also to receive CLIA waiver.
  • With the CLIA waiver, the Sofia 2 SARS Antigen+ FIA is deemed to be so simple and at such low risk of error that it no longer requires administration by trained clinical laboratory personnel, opening broader use in virtually any point-of-care setting equipped with Sofia 2 instruments.
  • “As the first company to introduce a rapid antigen test for COVID-19 when the FDA granted Emergency Use Authorization for the Sofia SARS Antigen FIA in May of 2020, and the first to receive De Novo FDA clearance for our Sofia 2 SARS Antigen+ FIA, it is gratifying to also be the first to receive a full CLIA waiver for our Sofia 2 SARS Antigen+ FIA,” said Douglas Bryant, President and Chief Executive Officer of QuidelOrtho.

bioAffinity Technologies Acquires Laboratory Assets of Precision Pathology Services

Retrieved on: 
Tuesday, September 19, 2023
Biotechnology, FDA, Other Health, Health, Radiology, Pharmaceutical, Oncology, Medical Devices, Surgery, Genetics, Clinical Trials, COPD, DNA, Fitzsimons Army Medical Center, American Board of Psychiatry and Neurology, College, Internal medicine, Louisiana State University, Marketing, Clinical Laboratory, SARS-CoV-2, CAP, Marie Cassidy, Pathology, Lung cancer, Lead, American Academy, College of American Pathologists, BIAF, Brooke Army Medical Center, Lung, Sale, Organization, American Board of Commissioners for Foreign Missions, STI, CLIA, Acquisition, Physician, Trustee, Psychiatry, American Academy of Neurology, Maria, American Board of Pathology, Medical imaging, Nursing, Neurology

bioAffinity Technologies, Inc. (Nasdaq: BIAF, BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer, announces the acquisition of the laboratory assets of Village Oaks Pathology Services, P.A., d/b/a Precision Pathology Services, a clinical laboratory accredited by the College of American Pathologists (CAP) and certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

Key Points: 
  • bioAffinity Technologies, Inc. (Nasdaq: BIAF, BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer, announces the acquisition of the laboratory assets of Village Oaks Pathology Services, P.A., d/b/a Precision Pathology Services, a clinical laboratory accredited by the College of American Pathologists (CAP) and certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
  • The laboratory assets are being acquired by a new wholly owned subsidiary of bioAffinity Technologies, Precision Pathology Laboratory Services, LLC (PPLS).
  • Precision Pathology provides pathology services to physicians practicing in a variety of outpatient settings and has offered bioAffinity Technologies’ CyPath® Lung as a laboratory developed test for the detection of early-stage lung cancer.
  • In addition to CyPath® Lung, Precision Pathology offers a range of laboratory services including respiratory testing for SARS-CoV-2 and influenza, anatomic pathology, morphological stains, histological services, DNA extractions, STI testing, and women’s and men’s health testing.

RetinalGeniX Technologies Inc. Focuses on Prevention of Blindness and Early Detection of Multiple Systemic Diseases

Retrieved on: 
Monday, September 18, 2023
OTC Markets Group, OTCQB, Paratriathlon, CLIA, Marker beacon, Patent, MD, IRB, Medical imaging

PETALUMA, Calif., Sept. 18, 2023 (GLOBE NEWSWIRE) -- RetinalGeniX Technologies Inc. (OTCQB:RTGN) (“RetinalGeniX” or the “Company”) released to the public via OTC Markets , a video webinar regarding the retinal screening medical device technology being developed by the Company to help prevent blindness and multiple systemic diseases, the Company’s business opportunities and the professional background of the Company’s management team.

Key Points: 
  • PETALUMA, Calif., Sept. 18, 2023 (GLOBE NEWSWIRE) -- RetinalGeniX Technologies Inc. (OTCQB:RTGN) (“RetinalGeniX” or the “Company”) released to the public via OTC Markets , a video webinar regarding the retinal screening medical device technology being developed by the Company to help prevent blindness and multiple systemic diseases, the Company’s business opportunities and the professional background of the Company’s management team.
  • CEO Jerry Katzman, MD, said, “We are no longer just a high-resolution retinal imaging company.
  • Dr. Katzman also noted that, “We were granted a patent for our Patient Home Monitoring and Integrated Physician Alert System for Ocular Anatomy in July 2023.
  • We are very excited about this patent.

Clinical whole genome sequencing test developed at The Jackson Laboratory

Retrieved on: 
Friday, September 15, 2023
Hospice and palliative medicine, DNA, CAP, Genome, Genetic distance, DSM-IV codes, APML, Jackson Laboratory, CLIA, Protein, Patient, JAX, Education minister, Diagnosis, Disease, Antibiotics, Vaccine

A decade ago, sequencing centers began offering clinical whole exome sequencing, but these only cover the portion of the genome that codes for proteins – approximately 1.5 percent of the entire genome.

Key Points: 
  • A decade ago, sequencing centers began offering clinical whole exome sequencing, but these only cover the portion of the genome that codes for proteins – approximately 1.5 percent of the entire genome.
  • To improve the diagnostic power of sequencing and identify the genetic basis of disease, the Advanced Precision Medicine Laboratory (APML) at The Jackson Laboratory for Genomic Medicine (JAX) in Farmington, Connecticut, is offering a fully validated, clinical whole genome sequencing test.
  • The APML is CLIA certified and CAP accredited and the JAX Genome test is the only clinical whole genome sequencing test currently offered in Connecticut.
  • The JAX Genome test includes DNA extraction from whole blood, sequencing of the genome, and variant analysis and interpretation.

Adaptive Announces Launch of Epic Integration for clonoSEQ®

Retrieved on: 
Wednesday, September 13, 2023
CLL, University of California, Davis, LDT, Partnership, Adaptation, Genetics, Chronic lymphocytic leukemia, Face, Multiple myeloma, Bone marrow, Acute lymphoblastic leukemia, Transplant, MRD, CLIA, UC, UC Davis Comprehensive Cancer Center, EHR, Patient, B-ALL, Blood, ADPT, Oncology, FDA, Recurrence, Disease, Pharmaceutical industry, Medical imaging, Epic

This integration will allow providers to order and review clonoSEQ minimal residual disease (MRD) testing results in Epic as they would for any test performed directly at the site of care.

Key Points: 
  • This integration will allow providers to order and review clonoSEQ minimal residual disease (MRD) testing results in Epic as they would for any test performed directly at the site of care.
  • clonoSEQ is also available for use in other lymphoid cancers and specimen types as a CLIA-validated laboratory-developed test (LDT).
  • Integration with Epic EHR provides convenient access to clonoSEQ MRD results along with discrete data directly in patient records, enabling faster, more efficient decision-making for oncologists and equipping patients with real-time insights into their disease status.
  • Practices that wish to access clonoSEQ MRD testing directly via Epic should contact their Adaptive account representative or Adaptive’s Account Operations team at [email protected].

Castle Biosciences Announces Receipt of New York Laboratory Permit for Pittsburgh Laboratory

Retrieved on: 
Tuesday, September 12, 2023
Health, Medical Devices, Other Science, Managed Care, Research, Science, Biotechnology, CAP, New York State Department of Health, CLIA, Patient, Laboratory, Physician, Castle, Growth, Pharmaceutical industry

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that the Company has received its Clinical Laboratory Permit from the New York State Department of Health for its laboratory in Pittsburgh.

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that the Company has received its Clinical Laboratory Permit from the New York State Department of Health for its laboratory in Pittsburgh.
  • “Castle is committed to serving patients through high-quality molecular tests that inform important care decisions in the management of conditions with high clinical need,” said Kristen Oelschlager, chief operating officer of Castle Biosciences.
  • “Successful completion of the rigorous New York State licensure process for our Pittsburgh laboratory reflects this commitment and expands our ability to positively impact patient care.”
    Castle operates clinical laboratories in Pittsburgh and Phoenix.
  • The new laboratory in Pittsburgh brings Castle’s total laboratory operations space to more than 52,000 square feet combined.

Indivumed Services’ Hamburg Site Receives College of American Pathologists (CAP) Accreditation

Retrieved on: 
Monday, September 11, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Accreditation, College, Crown Bioscience International, Service, CAP, Clinical trial, Multimedia, Doctor of Philosophy, Quality, Gesellschaft mit beschränkter Haftung, Certification, CLIA, Acquisition, Laboratory, Medical device, Nursing

Indivumed Services GmbH, a Crown Bioscience company, announced that its Hamburg site received laboratory accreditation from the College of American Pathologists (CAP).

Key Points: 
  • Indivumed Services GmbH, a Crown Bioscience company, announced that its Hamburg site received laboratory accreditation from the College of American Pathologists (CAP).
  • This distinction places Indivumed Services among the top 10% of laboratories globally, solidifying its commitment to excellence in laboratory services.
  • Overall, Indivumed Services’ CAP accreditation enhances its flexibility and enables the expansion of its services into new markets.
  • Simone Hubo, PhD, Vice President of Quality and Regulatory Affairs at Indivumed Services, stated: “With this accreditation, our customers can rest assured that the samples and analyses provided by Indivumed Services are of industry-leading quality.

Life Science: Cerba HealthCare to Acquire Canadian Contract Research Laboratory CIRION BioPharma Research to Expand Bioanalytical Capabilities and Shorten Time-to-Deploy Complex Clinical Trials

Retrieved on: 
Thursday, September 7, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Molecule, GLP, Drug development, College, Breeding, CAP, Clinical trial, Multimedia, Doctor of Philosophy, DSM-IV codes, Organization, CLIA, Medicine, IVD, Knowledge, Immunogenicity, ChromeOS, Medical device, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20230907759314/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230907759314/en/
    CIRION, a leading contract research organization has been operating global clinical trials over 30 years.
  • CIRION will rank under Cerba HealthCare’s business unit Cerba Research adding to its global network of cutting-edge laboratories in the Americas, Europe, Africa and Asia-Pacific.
  • Cerba Research CEO Mario Papillon said: “I see CIRION as a true strategic step in improving our offering both geographically and scientifically.
  • The CIRION scientists and experts are very excited to join Cerba Research in their continuous quest to provide the best possible solutions to serve and improve the clinical trials of our life science customers.”