CLIA

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

Retrieved on: 
Tuesday, December 5, 2023

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

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

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

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

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."

Mammogen to Showcase New Data at SABCS 2023 Demonstrating Clinical Efficacy of Its genTRU-breast™ qPCR Blood Test in Early-Stage Breast Cancer

Retrieved on: 
Friday, December 1, 2023

NEWPORT BEACH, Calif., Dec. 1, 2023 /PRNewswire/ -- Mammogen, a pioneering leader in women's health and a subsidiary of early detection parent company, IVBH, is set to present groundbreaking clinical data at the 2023 San Antonio Breast Cancer Symposium (SABCS). The poster, titled "Development of a plasma-based real-time qPCR gene expression assay for targeted screening and diagnosis of early-stage breast cancer," showcases the strength and innovation of Mammogen's proprietary genTRU-breast clinical assay.

Key Points: 
  • The poster, titled "Development of a plasma-based real-time qPCR gene expression assay for targeted screening and diagnosis of early-stage breast cancer," showcases the strength and innovation of Mammogen's proprietary genTRU-breast clinical assay.
  • —Elizabeth Cormier-May, CEO of Mammogen
    Abstract Title: Development of a plasma-based real-time qPCR gene expression assay for targeted screening and diagnosis of early-stage breast cancer.
  • This presentation follows Mammogen's successful CLIA validation of the genTRU-breast assay, announced last month , a landmark achievement for the company and a transformative milestone in early-stage breast cancer detection.
  • Elizabeth Cormier-May, CEO of Mammogen, commented, "This data is a testament to our commitment to unlocking the quality-of-life preservation that exists in the earliest stages of breast cancer.

Claris GenomiX announces licensing availability of ColoType, its patented mRNA-based Consensus Molecular Subtyping (CMS) assay for guiding colorectal cancer treatment decisions

Retrieved on: 
Thursday, November 16, 2023

"ColoType is the first commercially viable diagnostic capable of accurately subtyping colorectal cancer (CRC) tumors based on the industry-standard consensus molecular subtyping (CMS) system," said Jeff Sayre, CEO of Claris GenomiX.

Key Points: 
  • "ColoType is the first commercially viable diagnostic capable of accurately subtyping colorectal cancer (CRC) tumors based on the industry-standard consensus molecular subtyping (CMS) system," said Jeff Sayre, CEO of Claris GenomiX.
  • "We believe it has the potential to significantly improve the outcomes of colorectal cancer (CRC) patients."
  • According to Sayre, "since the consensus molecular subtypes (CMS) for colorectal cancer were published, numerous research publications have established its clinical utility.
  • Any partner with an already established CLIA lab could bring this powerful assay to market relatively quickly and start making a difference in the lives of colorectal cancer patients."

Mammogen Achieves CLIA Validation of gen-TRU-breast™ Assay

Retrieved on: 
Wednesday, November 15, 2023

NEWPORT BEACH, Calif., Nov. 15, 2023 /PRNewswire/ -- Mammogen, a leader in women's health and bellwether subsidiary of early detection parent company IVBH, has announced the successful completion of Clinical Laboratory Improvement Amendments (CLIA) validation for its pioneering plasma-based clinical assay, genTRU-breast, a test designed to detect the earliest stages of breast cancer. This achievement represents a momentous step forward in revolutionizing breast health. 

Key Points: 
  • After two decades effecting change in commercial diagnostics, this achievement is the brightest spot of my career, with a profound culmination of scientific, clinical, and social impact," —Elizabeth Cormier-May, Mammogen CEO.
  • genTRU-breast, a state-of-the-art real-time qPCR assay, is designed to detect early-stage breast cancer with unparalleled precision.
  • In CLIA validation, leveraging proprietary AI/ML, the genTRU-breast clinical assay achieved a statistically significant >99% sensitivity, 89% specificity in stage I breast cancer (p
  • With CLIA validation of this assay now complete, Mammogen will work diligently to commercially launch genTRU-breast in 2H 2024, a timeline aligned with the nationwide implementation of the Mammography Quality Standards Act (MQSA).

Inflammatix Completes Technical Development for TriVerity™ Acute Infection and Sepsis Test System

Retrieved on: 
Wednesday, November 15, 2023

SUNNYVALE, Calif., Nov. 15, 2023 /PRNewswire/ -- Inflammatix, Inc., a pioneering molecular diagnostics company, announced today that the company has completed technical development for its TriVerity™ Acute Infection and Sepsis Test System, which includes the Myrna™ Instrument, and for the TriVerity™ Cartridge. TriVerity is intended to be used in emergency department settings in patients with suspected acute infection and sepsis to assess the likelihood of a bacterial infection, a viral infection, and risk of acute decompensation (the need for ICU-level care).    

Key Points: 
  • SUNNYVALE, Calif., Nov. 15, 2023 /PRNewswire/ -- Inflammatix, Inc., a pioneering molecular diagnostics company, announced today that the company has completed technical development for its TriVerity™ Acute Infection and Sepsis Test System, which includes the Myrna™ Instrument, and for the TriVerity™ Cartridge.
  • TriVerity is intended to be used in emergency department settings in patients with suspected acute infection and sepsis to assess the likelihood of a bacterial infection, a viral infection, and risk of acute decompensation (the need for ICU-level care).
  • The TriVerity Acute Infection and Sepsis Test, Inflammatix's lead product, incorporates a panel of 29 mRNAs to "read" the body's immune response and thus aid in the diagnosis of patients with suspected acute infection and sepsis.
  • The TriVerity Acute Infection and Sepsis Test System is a product in development, is not for sale, and does not have marketing approval or clearance from regulatory authorities in any jurisdiction.

Lucid Diagnostics Launches Next-Generation EsoGuard® Esophageal DNA Test and Announces Upcoming Investor Day

Retrieved on: 
Thursday, November 9, 2023

NEW YORK, Nov. 9, 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 that its CAP-accredited, CLIA-certified laboratory, LucidDx Labs, Inc., has launched the next generation of the EsoGuard® Esophageal DNA test ("EsoGuard 2.0") for the detection of esophageal precancer, having demonstrated enhanced assay performance and lower costs in extensive validation studies. All commercial and research samples received by the laboratory will now be processed using the EsoGuard 2.0 assay. Lucid also announced that it will be hosting an Investor Day on December 13, 2023, in New York City.

Key Points: 
  • Lucid also announced that it will be hosting an Investor Day on December 13, 2023, in New York City.
  • The EsoGuard assay involves first extracting DNA from esophageal cells collected by the EsoCheck® Cell Collection Device.
  • Lucid will host an Investor Day event to be held in New York, NY on December 13, 2023.
  • Details on how to register for the Investor Day will be made available on the Investor Relations section of the Company's website.