CLIA

Rose Hill and ACS Laboratory Join Forces to Pioneer Psilocybin Testing Standards

Retrieved on: 
Tuesday, December 12, 2023
ISO/IEC, Partnership, Microbiology, Research, Fungus, QR, Psilocybin, Certification, CLIA, Biomass, ACS, COA, DEA, Growth, Patient, CPG, Mycotoxin, Pharmaceutical industry

RUNAWAY BAY, Jamaica, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Rose Hill (or the “Company”), a premium psilocybin cultivator, supplier processor, and exporter in Jamaica, has announced a groundbreaking partnership with ACS Laboratory, an award-winning testing facility.

Key Points: 
  • RUNAWAY BAY, Jamaica, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Rose Hill (or the “Company”), a premium psilocybin cultivator, supplier processor, and exporter in Jamaica, has announced a groundbreaking partnership with ACS Laboratory, an award-winning testing facility.
  • Rose Hill has been a trailblazer in producing top-tier, multi-strain psilocybin genetics and innovative cultivation solutions since its establishment in 2015.
  • Today, it allows Rose Hill to harness ACS Laboratory’s testing methodologies to launch forthcoming studies in 2024.
  • Roger Brown, president of ACS Laboratory, said, "The partnership between ACS Laboratory and Rose Hill reflects a shared dedication to responsible growth in the psilocybin market.

Mangoceuticals Selects TRYBE Labs as its Nationwide Blood Collection and Testing Services Provider

Retrieved on: 
Wednesday, November 29, 2023
Paramount, Marketing, Partnership, Physician, Male, FDA, Health, CLIA, Patient, Joint Commission, Erectile dysfunction, Pharmaceutical industry

Dallas, Texas, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling a variety of men’s health and wellness products via a secure telemedicine platform, including its uniquely formulated hair growth product branded ‘GROW’ and erectile dysfunction (ED) drug branded “Mango,” today announced that it has selected TRYBE Labs to provide its customers with a minimally invasive FDA approved at-home blood collection device and testing services as the Company seeks to further expand its product lines requiring blood tests and results reviewed by physicians.

Key Points: 
  • Using innovative, FDA approved at-home blood collection technology, TRYBE Labs is a CLIA certified and Joint Commission accredited laboratory that provides a direct-to-consumer product which includes an easy-to-use collection kit, full range of testing, and physician-read results for male health and performance evaluation - including hormone, thyroid and vitamin levels.
  • “TRYBE Labs offers a unique, innovative, convenient, and minimally invasive approach for blood collection and testing along with fast result turnaround times (in as little as 72 hours) for patients across the United States.
  • “TRYBE Labs was built by men, for men,” said Lewis Scalione, Founding Partner, TRYBE Labs.
  • By putting the power of information and cutting-edge technology directly into their hands, we are making healthcare more accessible to all who need it.”

binx health Expands Nationwide Distribution of the binx io Molecular Point-of-Care Platform

Retrieved on: 
Monday, November 27, 2023
STI, Male, FDA, POC, Gonorrhea, Thermo Fisher Scientific, CLIA, World Congress, Chlamydia, Diagnosis, Female

BOSTON, Nov. 27, 2023 (GLOBE NEWSWIRE) -- binx health, a healthcare technology and diagnostics company focused on making routine testing convenient, today announced it has entered into a non-exclusive national distribution agreement with Fisher Healthcare, a part of Thermo Fisher Scientific, to expand the rollout of the CLIA-waived, FDA-cleared binx io, which will increase access to care and improve the timely diagnosis of chlamydia (CT) and gonorrhea (NG).

Key Points: 
  • BOSTON, Nov. 27, 2023 (GLOBE NEWSWIRE) -- binx health, a healthcare technology and diagnostics company focused on making routine testing convenient, today announced it has entered into a non-exclusive national distribution agreement with Fisher Healthcare, a part of Thermo Fisher Scientific, to expand the rollout of the CLIA-waived, FDA-cleared binx io, which will increase access to care and improve the timely diagnosis of chlamydia (CT) and gonorrhea (NG).
  • The binx io is the only molecular point-of-care (POC) platform proven to detect CT and NG in both male and female patient samples that provides central lab performance in about thirty minutes.
  • Data presented at the STI & HIV 2023 World Congress in Chicago demonstrated that hands-on-time for the POC binx io is statistically the same as the hands-on-time for collecting a CT/NG sample for send out to a central lab.
  • CT/NG results from the binx io were available days before test results were available from the central lab CT/NG test [1].

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.

Predictive Oncology Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 14, 2023
Calibration, UPMC Magee-Womens Hospital, GMP, Conference call, CLIA, Administration, Depreciation, Patient, Science, Intelligence, G&A, Machine learning, Marketing, Call, Conference, Ovarian cancer, Survival, Growth, CRH, UPMC, Holocene, Drug development, Pharmaceutical industry, Cryptocurrency, Video game

The company reported a net loss of $3.2 million on total net revenue of $0.7 million for the third quarter 2023.

Key Points: 
  • The company reported a net loss of $3.2 million on total net revenue of $0.7 million for the third quarter 2023.
  • Reported a 22% reduction in net loss in the third quarter of 2023 versus the third quarter of 2022, driven by lower General and Administrative expenses.
  • Loss per common share for Q3 2023 was $0.78, as compared to $1.04 for the third quarter of 2022.
  • Predictive Oncology recorded revenue of $715,056 in the third quarter of 2023, compared to $455,827 for the comparable period in 2022.

Mercy Ships “A Transformational Journey” Miami Signature Event Wins Widespread Support

Retrieved on: 
Tuesday, December 5, 2023
Nursing, Surgery, Hospitals, Maritime, Transport, Philanthropy, Practice Management, Managed Care, Health, Foundation, The Temple House, African, Hope, AON, Love, CLIA, Commerce, Art Deco, Patient, Multimedia, Coral Gables, Florida, Goldman Sachs, Mercy, COMPASS, Caregiver, SES, WISTA, MV Global Mercy, Corporate development, In-group and out-group, Mercy Ships, New business development, Safe harbor, Microsoft, The, Hospital, Management

View the full release here: https://www.businesswire.com/news/home/20231205496056/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231205496056/en/
    Mercy Ships celebrates at 'The Transformational Journey' event alongside presenting sponsors inGroup International.
  • From (L to R): Kees-Jan de Maa, Media Director, inCruises; Michael Hutchison, Co-Founder & Co-CEO, inGroup International; Cecilia Villa, Vice President of Resource Development, Mercy Ships; Simone Jones, Director of New Business Development, Mercy Ships; Clark Rachuig, Corporate Development Manager, Mercy Ships; Heather Hutchison, Michael Hutchinson’s wife.
  • Special acknowledgements are extended to Mercy Ships supporters from the Sierra Leone Consulate and the Miami-Dade County Mayor’s Office.
  • These funds will provide the much-needed support for Mercy Ships’ patients as they prepare for their surgery and as they recover post-procedure.

Researchers Identify New Cost Savings and Accuracy of C2N Diagnostics’ Blood Tests to Enable Healthcare Providers to Better Identify Alzheimer’s Disease

Retrieved on: 
Thursday, November 16, 2023
Research, Other Health, General Health, Pharmaceutical, Mental Health, Medical Devices, Clinical Trials, Science, Neurology, Biotechnology, Medical Supplies, Health, Other Science, Classification, Hypertension, Associate, Brain, Diagnosis, Deficit spending, RUO, APS2, CBD, Pathology, Ageing, AUC, Amyloid, Plasma, Disease, Peptide, CLIA, PSP, CSF, Non-fungible token, Patient, Research and development, LDT, MCI, FDA, Neuropathology, FTD, C2N, Physiology, Therapy, Dementia, Frontotemporal dementia, University, Corticobasal degeneration, Development, Clinical trial, Body mass index, Emilie Rissman, Biomarker, PET, Diabetes, Medical imaging, Medical device, Alzheimer's disease, Biostatistics, Medicine, Neuroscience

Dr. Joel Braunstein, CEO of C2N Diagnostics, said, “This year’s CTAD conference was a great success for C2N Diagnostics and the field as a whole.

Key Points: 
  • Dr. Joel Braunstein, CEO of C2N Diagnostics, said, “This year’s CTAD conference was a great success for C2N Diagnostics and the field as a whole.
  • Many independent researchers and collaborators presented important findings about our Precivity line of blood tests, affirming these clinical tools are aiding healthcare providers in the diagnosis and treatment of Alzheimer’s disease.
  • The tests are also helping researchers address key biological questions about the disease, who is at elevated risk, and how blood tests can help in everyday clinical practice.
  • The MTBR-tau fluid biomarker can be used in the diagnosis of AD, in disease staging, and in the development of tau-directed therapeutics.

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.

Cruise Lines International Association announces the promotion of Donnie Brown to Senior Vice President of Global Maritime Policy

Retrieved on: 
Wednesday, December 6, 2023
Cruise Lines International Association, Safety, Policy, Senior, International Association, CLIA, Cruise line, International Maritime Organization, Health, University, Biophysical environment, Human, Coast guard, Management

WASHINGTON, Dec. 6, 2023 /PRNewswire/ -- Cruise Lines International Association (CLIA), the leading voice for the global cruise industry, announced the promotion of Donnie Brown to Senior Vice President, Global Maritime Policy, effective December 1, 2023.

Key Points: 
  • WASHINGTON, Dec. 6, 2023 /PRNewswire/ -- Cruise Lines International Association (CLIA), the leading voice for the global cruise industry, announced the promotion of Donnie Brown to Senior Vice President, Global Maritime Policy, effective December 1, 2023.
  • "Donnie has made significant contributions to CLIA and the cruise industry over the past nine years, and I am thrilled for him to now take the helm as Senior Vice President, Global Maritime Policy," said Kelly Craighead, President and CEO of CLIA.
  • Brown joined CLIA in 2014 as Director of Environmental and Health and was promoted to Vice President, Global Maritime Policy in 2017.
  • Additionally, in close consultation with the CLIA Global Committee on Marine Environment Protection, he led delegations to the International Maritime Organization, where he represented the global cruise industry during international treaty negotiations and other matters.

Biofidelity launches ASPYRE®-Lung reagents, enabling laboratories worldwide to perform rapid precision genomic analysis

Retrieved on: 
Wednesday, December 6, 2023
Research, RUO, CLIA, PCR, LDT, Laboratory, Technical director, RESEARCH, Doctor of Philosophy, Neoplasm

CAMBRIDGE, England and RESEARCH TRIANGLE PARK, N.C., Dec. 6, 2023 /PRNewswire/ -- Biofidelity today announced the commercial launch of its ASPYRE®-Lung RUO reagent product.

Key Points: 
  • CAMBRIDGE, England and RESEARCH TRIANGLE PARK, N.C., Dec. 6, 2023 /PRNewswire/ -- Biofidelity today announced the commercial launch of its ASPYRE®-Lung RUO reagent product.
  • ASPYRE-Lung dramatically simplifies and accelerates the detection of genomic biomarkers, enabling localized testing at a fraction of the cost of current sequencing tests, with results available in days instead of weeks.
  • "Both launches represent a major step toward decentralizing genomic testing and enabling enhanced access to critical biomarker testing through our CLIA laboratory and research customers."
  • "ASPYRE-Lung RUO will help us enable our physician customers to provide rapid input into their research projects."