CLIA

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
CLIA, Health, Breast cancer, Poster, Real-time, Diagnosis, Medical imaging

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
Research, Colorectal cancer, CRC, CLIA, Laboratory, Patient, LDT, Death, Neoplasm, CMS, Cancer, Survival, Claris, Publication, RNA, Medical imaging, Pharmaceutical industry

"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
Health, Breast cancer, Messenger, Patient, Real-time, RNA, CLIA

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
SHIELD, Sale, Robert Trivers, Food, AHRQ, Risk, CLIA, Database, Sepsis, Patient, Medicine, Agency, Viral, FDA, Infection, Acute decompensated heart failure, RNA, Diagnosis, Genetically modified bacteria, Messenger, HCUP, Immunotherapy, Vaccine, Pharmaceutical industry, Myrna

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
Esophageal cancer, AMP, Research, CLIA, National Cancer Institute, Esophageal disease, Case Western Reserve University, Lucid, CCNA1, Methylation, NGS, VIM, Polymerase chain reaction, Gene, Cancer, Invention, DNA, Vaccine

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.

Study demonstrates clinical utility of polygenic risk scores for cardiovascular disease in multiple ancestries

Retrieved on: 
Thursday, November 9, 2023
PRS, Laboratory, United Kingdom, CAD, Genetic testing, Genetics, CAP, Coronary artery disease, Research, CLIA, Genomics, Disease, Risk, Nature Communications, LDL, Medicine, Partnership, Patient, Cardiovascular disease, Pharmaceutical industry, Medical device

NEW YORK, Nov. 9, 2023 /PRNewswire/ --Allelica, a leading provider of clinical bioinformatics technology, has announced its scientific team's publication of their latest research in Nature Communications. The publication, "Ancestry-specific polygenic risk scores are risk enhancers for clinical cardiovascular disease assessments", builds on the company's ongoing efforts to make polygenic risk scores (PRSs) for coronary artery disease (CAD) accessible in healthcare settings for individuals of all ancestries. This research marks a significant milestone in Allelica's mission to revolutionize healthcare by harnessing the power of PRS. 

Key Points: 
  • The publication, "Ancestry-specific polygenic risk scores are risk enhancers for clinical cardiovascular disease assessments", builds on the company's ongoing efforts to make polygenic risk scores (PRSs) for coronary artery disease (CAD) accessible in healthcare settings for individuals of all ancestries.
  • Key findings of the publication include:
    Allelica's CAD PRSs identify individuals at high genetic risk of disease across all major genetic ancestry groups.
  • Using high CAD PRS as a risk factor leads to more accurate clinical risk assessments compared to models that don't use genetic information.
  • Our results highlight the transformative potential of polygenic risk scores to identify this risk and use it in clinical risk assessments for one of the most common, and preventable diseases - coronary artery disease.

Predictive Oncology to Report Third Quarter 2023 Financial Results and Host Conference Call and Webcast on Tuesday, November 14, 2023

Retrieved on: 
Tuesday, November 7, 2023
Oncology, GMP, Intelligence, CLIA, Conference, Good, Good manufacturing practice, Machine learning, Drug development, Pharmaceutical industry, Broadcasting

EAGAN, Minn., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ: POAI), a science-driven company leveraging its proprietary artificial intelligence and machine learning capabilities, extensive biorepository of tumor samples, Clinical Laboratory Improvement Amendments (CLIA) laboratory and Good Manufacturing Practices (GMP) facility, to accelerate oncology drug discovery and enable drug development, today announced that it will report its financial results for the third quarter ended September 30th, 2023 before the markets open on Tuesday, November 14, 2023.

Key Points: 
  • EAGAN, Minn., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ: POAI), a science-driven company leveraging its proprietary artificial intelligence and machine learning capabilities, extensive biorepository of tumor samples, Clinical Laboratory Improvement Amendments (CLIA) laboratory and Good Manufacturing Practices (GMP) facility, to accelerate oncology drug discovery and enable drug development, today announced that it will report its financial results for the third quarter ended September 30th, 2023 before the markets open on Tuesday, November 14, 2023.
  • The company will host a corporate update conference call and live audio webcast at 8:30 a.m. on that day.
  • Live Conference Call & Webcast:

Veracyte Announces In Vitro Diagnostic Agreement with Illumina to Broaden Availability of Its Tests for Patients Globally

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Medical Devices, Health, Pharmaceutical, Oncology, Laboratory, Real-time, IVD, Physician, Illumina, Inc., CLIA, NGS, Cancer, Hospital, Smoker, Patient, Diagnosis, Pharmaceutical industry, Medical imaging, Illumina

(Nasdaq: VCYT) today announced that it has entered into a multi-year agreement with Illumina, Inc. (Nasdaq: ILMN) to develop and offer some of its high-performing molecular tests as decentralized in vitro diagnostic (IVD) tests on Illumina’s NextSeq 550Dx next-generation sequencing (NGS) instrument.

Key Points: 
  • (Nasdaq: VCYT) today announced that it has entered into a multi-year agreement with Illumina, Inc. (Nasdaq: ILMN) to develop and offer some of its high-performing molecular tests as decentralized in vitro diagnostic (IVD) tests on Illumina’s NextSeq 550Dx next-generation sequencing (NGS) instrument.
  • The agreement is part of Veracyte’s expanded, multi-platform IVD approach, which will also include qPCR and is designed to accelerate the company’s ability to make its tests available to more patients globally.
  • The first tests that Veracyte plans to develop for the Illumina NextSeq 550Dx instrument are its Prosigna Breast Cancer Assay and Percepta Nasal Swab test.
  • Prosigna is already commercially available as an IVD test that helps inform treatment decisions for patients with early-stage breast cancer.

PreciseDx's "Analytical Validation of a Digital Breast Cancer Test Predicting Recurrence in Early-Stage Breast Cancer" Featured in Clinical Breast Cancer

Retrieved on: 
Tuesday, November 7, 2023
Standard of care, LDT, New York State Department of Health, Doctor of Philosophy, Health, Artificial intelligence, CLIA, Disease, Risk, Recurrence, Machine learning, IBC, Breast cancer, Histology, NYSDOH, Clinical Breast Cancer, Breast Cancer Research, Patient, Medical device, Medical imaging

NEW YORK, Nov. 7, 2023 /PRNewswire/ -- PreciseDx®, a leading innovator in oncology diagnostics, leveraging Artificial Intelligence (AI) for revolutionary, morphology-driven, disease analysis, today announced that its analytical validation study for its PreciseBreast™ assessment has been published in the November 3, 2023 issue of Clinical Breast Cancer.

Key Points: 
  • Collectively, these studies demonstrated an analytical performance that accurately predicts early-stage breast cancer risk of recurrence within 6 years.
  • PreciseBreast™ is an in vitro prognostic test that predicts breast cancer recurrence for patients diagnosed with early-stage IBC.
  • This latest study builds upon PreciseDx's earlier clinical validation study published in Breast Cancer Research (cited 2022 Dec 21, 24:93.
  • "Our innovative digital assessment holds immense promise in enhancing early-stage breast cancer recurrence prediction, ultimately improving patient care and outcomes.

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.