LDT

inFoods® IBS Test Now Validated for Use with Simple Finger Stick Whole Blood Collection Technology

Retrieved on: 
Thursday, May 18, 2023
LDT, Mayo Clinic, University, Lab, CAP, API, Abdominal pain, Irritable bowel syndrome, Houston Methodist Hospital, Trial of the century, Harvard Medical School, DDW, Patient, IBS, Blood, Hospital, Medical device, Pharmaceutical industry, Nursing

The inFoods® IBS diagnostic test has now been validated for use with finger stick (capillary) patient whole blood samples simplifying sample collection and facilitating wider access to the test.

Key Points: 
  • The inFoods® IBS diagnostic test has now been validated for use with finger stick (capillary) patient whole blood samples simplifying sample collection and facilitating wider access to the test.
  • This workflow enhancement greatly simplifies the process for healthcare providers to order the inFoods IBS test and is much easier for patients.
  • The InFoods IBS test will continue to be available using blood collected from a patient’s arm (venipuncture) by a trained phlebotomist.
  • "By enabling the use of finger stick whole blood samples, we're making our personalized IBS therapy more convenient and easier than ever.

Cardio Diagnostics Holding, Inc’s Actionable Clinical IntelligenceTM (ACI) Platform Offers New Epigenetic and Genetic Insights to Inform Coronary Heart Disease Management

Retrieved on: 
Tuesday, May 16, 2023
Health, Technology, Health Technology, General Health, Artificial Intelligence, Cardiology, Biotechnology, Blood pressure, LDT, Genetics, Cholesterol, Moyamoya disease, Absenteeism, Risk assessment, Intelligence, Risk, Biomarker, Patient, Entrepreneurship, AI, ACI, CHD, Pharmaceutical industry, Medical imaging

ACI offers new data-driven insights into the epigenetic and genetic molecular underpinnings of coronary heart disease (CHD).

Key Points: 
  • ACI offers new data-driven insights into the epigenetic and genetic molecular underpinnings of coronary heart disease (CHD).
  • ACI’s analytics framework integrates LDT results with a patient’s unique epigenetic and genetic biomarkers and clinical information to provide deeper and actionable insights to clinicians about factors driving the patient’s CHD.
  • Meesha Dogan, Ph.D., CEO and Co-Founder at Cardio Diagnostics, remarked, "Cardio Diagnostics remains steadfast in its commitment to driving innovation in cardiovascular medicine.
  • The launch of Actionable Clinical Intelligence marks a significant milestone in our mission to revolutionize the prevention, management, and treatment of coronary heart disease.

BIO-TECHNE ANNOUNCES LAUNCH OF KAPPA AND LAMBDA RNAscope ISH PROBES AS ANALYTE SPECIFIC REAGENTS (ASRs) FOR THE DETECTION OF IMMUNOGLOBULIN KAPPA AND LAMBDA LIGHT CHAINS mRNA

Retrieved on: 
Wednesday, May 10, 2023
GMP, Tissue, Malignancy, ISO, Research, Biomarker, IHC, CLIA, Lymphoma, Patient, Flow cytometry, Immunohistochemistry, LDT, Laboratory developed test, ASR, ACD, Medical imaging, Medical device, Genomics, Lambda

Immunoglobulin kappa and lambda chains are important biomarkers for the assessment of B-cell clonality.

Key Points: 
  • Immunoglobulin kappa and lambda chains are important biomarkers for the assessment of B-cell clonality.
  • Flow cytometry is the current gold standard for assessing kappa and lambda light chains, but it may not be effective for certain B-cell lymphomas that lack surface immunoglobulin expression.
  • RNAscope ISH Probes Kappa and Lambda are designed to detect immunoglobulin kappa and lambda light chains mRNA.
  • RNAscope probes are visualized with the highly sensitive RNAscope ISH detection reagents, which are compatible with FFPE tissue.

Quanterix Releases Operating Results for First Quarter 2023

Retrieved on: 
Tuesday, May 9, 2023
Health, Biometrics, Health Technology, Research, Science, Biotechnology, News, LDT, AFL, GAAP, Baozou Big News Events, Biomarker, Corporation, Publication, Webcast, Growth, Poster, FDA, Nerve, ALS, Mobile phone, Pharmaceutical industry

Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced financial results for the three months ended March 31, 2023.

Key Points: 
  • Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced financial results for the three months ended March 31, 2023.
  • Gross margin, a key success indicator of the strategic realignment, saw strong quarter over quarter improvement.
  • The technology was highlighted in more than 140 new publications in the first quarter 2023, bringing total Simoa-specific inclusions to over 2,200 as of March 31, 2023.
  • In conjunction with this announcement, Quanterix Corporation will host a conference call on May 9, 2023, at 4:30 p.m. Eastern Time.

Guardant Health Announces Additions to Leadership Team

Retrieved on: 
Monday, May 8, 2023
Oncology, Health, Medical Devices, Biometrics, Health Technology, General Health, Biotechnology, Fresenius Medical Care, Quest Diagnostics, LDT, Ines, Daria (name), Eye, Illumina, Multimedia, Research, GH, Dialysis, Helmy Eltoukhy, Humboldt University of Berlin, UC, Patient, University of California, Irvine, Bachelor of Arts, Knowledge, CDX, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Management

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the expansion of its leadership team with the addition of Ines Dahne-Steuber as chief operating officer and the promotion of Darya Chudova to chief technology officer.

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the expansion of its leadership team with the addition of Ines Dahne-Steuber as chief operating officer and the promotion of Darya Chudova to chief technology officer.
  • Prior to joining Guardant Health, she served as senior vice president of operational excellence and president of Spectra Laboratories at Fresenius Medical Care North America.
  • Darya Chudova has been with Guardant Health for eight years, most recently serving as the senior vice president of technology.
  • “We are very pleased to welcome Ines to Guardant’s leadership team.

Applied BioCode Announces Distribution Agreement with Medline Industries

Retrieved on: 
Monday, May 8, 2023
Infectious Diseases, Biotechnology, Hospitals, Health, EUA, Hair, Bachelor, BMB, Allergy, RPP, Medline Industries, SARS-CoV-2, COVID-19, Infection, CE marking, Applied Food Technologies, MEDLINE, Nomenclature codes, Lower respiratory tract infection, Immunochemistry, Emergency Use Authorization, Federal Food, Drug, and Cosmetic Act, Hospital, RSV, Analyte-specific reagent, Laboratory, Autoimmune disease, Molecular Probes, LDT, IVD, Diagnosis, GPP, FDA, Virus, Pharmaceutical industry, Vaccine

Applied BioCode today announced an agreement with Medline Industries, a leading manufacturer and distributor of healthcare products, to distribute the MDx-3000 System and its comprehensive menu.

Key Points: 
  • Applied BioCode today announced an agreement with Medline Industries, a leading manufacturer and distributor of healthcare products, to distribute the MDx-3000 System and its comprehensive menu.
  • Under the terms of the distribution agreement, Medline will offer the MDx-3000 System to clinical laboratory customers across the U.S.
    “Applied BioCode is thrilled to partner with Medline Industries, and we look forward to continuing our expansion into hospitals and reference laboratories in the U.S.,” said Chris Bernard, CEO of Applied BioCode.
  • For more information on the Applied BioCode’s platform and products, visit: https://apbiocode.com/products.htm
    Applied BioCode is an IVD manufacturer that designs, develops, and commercializes multiplex testing products.
  • Applied BioCode, Inc. has also been granted an Emergency Use Authorization (EUA) from the U.S. FDA for its BioCode® SARS-CoV-2 Flu Plus Assay ⱡ, BioCode® SARS-CoV-2 Assay*, and an additional EUA for Pooled COVID-19 Testing*.

BCAL DIAGNOSTICS OPENS NEW LABORATORY IN SYDNEY AS IT ACCELERATES DEVELOPMENT OF ITS BREAST CANCER BLOOD SCREENING TOOL

Retrieved on: 
Thursday, May 4, 2023
LDT, Therapeutic Goods Administration, Accreditation, ISO, Lipid, Woman, ASX, Research, Plasma, CLIA, LCMS, Patient, Algorithm, Instrumental chemistry, Therapeutic Goods Act 1989, BCAL, BDX, Breast cancer, Medical device, Medical imaging

SYDNEY, May 4, 2023 /PRNewswire/ -- BCAL Diagnostics Limited (ASX:BDX) (BCAL or Company) an Australian-based biotechnology company announced the opening of its development and clinical service laboratory in Sydney. This step marks an important milestone for the company as it advances commercialization of its non-invasive blood screening that is initially intended to be used alongside other breast cancer screening methods, with results to date demonstrating 91% sensitivity and 80% specificity. The technology will initially complement current imaging technologies, such as the mammogram, while BCAL further progresses the development of a monitoring and screening test suitable for women of all ages and backgrounds in any location.

Key Points: 
  • SYDNEY, May 4, 2023 /PRNewswire/ -- BCAL Diagnostics Limited (ASX:BDX) (BCAL or Company) an Australian-based biotechnology company announced the opening of its development and clinical service laboratory in Sydney.
  • Patient samples will be collected and forwarded to BCAL's laboratory, where they will be tested for the proprietary BCAL lipid signature that is expressed by breast cancer cells.
  • "We plan to use this laboratory for a variety of purposes leading up to and following product approval and availability.
  • To learn more about BCAL Diagnostics or to participate in BCAL's research, you can register your interest online at www.bcaldiagnostics.com .

New York State Department of Health Approves PathoZoom Rapid On Site Evaluation in Fine Needle Aspirates Specimens LDT

Retrieved on: 
Thursday, May 4, 2023
Health Technology, Health Insurance, Data Management, Other Health, Technology, Healthcare Reform, General Health, Medical Devices, Infectious Diseases, Public Policy, Government, Clinical Trials, Other Technology, Science, Research, Health, Medical Supplies, Cloud, LiveView, Laboratory, LDT, Travel, Workflow, Marie Cassidy, CLEP, NYSDOH, ROSE, New York State Department of Health, Medical director, Scan, Television, Medical device

The New York State Department of Health has approved Cayuga Health System to use a Smart In Media PathoZoom LiveView laboratory developed test (LDT) image-based method for digital slide sharing - Rapid On Site Evaluation (ROSE) in fine needle aspirates specimens, the company said on Tuesday.

Key Points: 
  • The New York State Department of Health has approved Cayuga Health System to use a Smart In Media PathoZoom LiveView laboratory developed test (LDT) image-based method for digital slide sharing - Rapid On Site Evaluation (ROSE) in fine needle aspirates specimens, the company said on Tuesday.
  • With the approval, Cayuga can begin testing patient samples using its PathoZoom system in the state of New York through its CLIA-certified laboratory.
  • The Clinical Laboratory Evaluation Program (CLEP) used to validate the assay is among the most important and rigorous levels of validation for LDTs, Smart In Media noted.
  • Each LDT submitted to the NYSDOH must undergo review for analytical and clinical performance, as well as reproducibility.

FDA Accelerated Approval of Tofersen Highlights Importance of Blood Neurofilament Light Chain as Surrogate Endpoint in Neurology Therapeutic Trials

Retrieved on: 
Tuesday, April 25, 2023
Science, Research, General Health, Health, FDA, Technology, Genetics, Other Technology, LDT, Partex Group, Therapy, AFL, Serum, Survival, Infection, Limit, Massachusetts General Hospital, Biomarker, Multiple sclerosis, DSM-IV codes, Amyloidosis, Plasma, CLIA, Protein, Corporation, Publication, RRMS, SOD1, Patient, Laboratory, Mass, Blood, Simoa, Laboratory developed test, Neurology, Cardiology, Phase, ALS, News, Disease, Pharmaceutical industry, Medical imaging

This is the first known case in which a blood biomarker was successfully used as a surrogate endpoint for a neurology therapeutic trial to gain accelerated approval, highlighting the potential for other therapeutic trial designs to benefit from including blood NfL measurements.

Key Points: 
  • This is the first known case in which a blood biomarker was successfully used as a surrogate endpoint for a neurology therapeutic trial to gain accelerated approval, highlighting the potential for other therapeutic trial designs to benefit from including blood NfL measurements.
  • This data supported an extended FDA review of tofersen’s new drug application under the accelerated pathway leading to its recent announcement of approval.
  • The FDA’s decision to approve tofersen through its Accelerated Approval Program focused on strong surrogate biomarker data, adding momentum to the use of biomarkers in predicting disease severity and clinical benefit in neurodegenerative diseases.
  • NfL, in particular, has been extensively studied in different neurodegenerative diseases, including Alzheimer’s, spinal muscular atrophy, hereditary transthyretin-mediated amyloidosis, and multiple sclerosis.

Gestalt Takes First Place in Two Separate International AI Algorithm Challenges

Retrieved on: 
Friday, April 21, 2023
Gestalt, LDT, International, Education, MICCAI, CAP, Marie Cassidy, Pancreatic cancer, Pathology, Multimedia, ICC, RUO, Breast cancer, Physician, Algorithm, Colorectal cancer, Medical device, Medical imaging

SPOKANE, Wash., April 21, 2023 /PRNewswire/ -- Gestalt Diagnostics is honored to have taken 1st place in both International challenges. Hundreds of groups participated in each challenge and Gestalt's algorithms achieved highest ranking.

Key Points: 
  • SPOKANE, Wash., April 21, 2023 /PRNewswire/ -- Gestalt Diagnostics is honored to have taken 1st place in both International challenges.
  • In September 2022 Gestalt was awarded 1st place in MICCAI's Automatic Registration of Breast Cancer Tissue challenge.
  • On April 18th, 2023 Gestalt was named the 1st place winner in the PAIP'sTumor Cellularity Prediction in Pancreatic Cancer and Colon Cancer challenge.
  • "These challenges are an excellent opportunity to compare and validate the techniques Gestalt uses to develop state-of-the-art image analysis algorithms, that support the diagnostic workflow of physicians who utilize our digital pathology platform," says Brian Napora, Gestalt VP, AI Solutions.