Cepheid variable

Concert Announces Clinical Advisory Board, New Medical Policies

Retrieved on: 
onsdag, maj 1, 2024

NASHVILLE, Tenn., May 1, 2024 /PRNewswire/ -- As part of its commitment to provide transparent, evidence-based medical policy and enable accurate reimbursement for a broader set of diagnostic services, Concert today announced the establishment of an advisory board of experts in clinical laboratory medicine and the release of policies for an expanded scope of routine and advanced laboratory testing.

Key Points: 
  • The newly formed board will advise Concert on its clinical laboratory content.
  • "Concert is working to align payers, providers, and labs to enable patient access to evidence-based testing," said Dr. Girish Putcha.
  • Following are brief bios on each member of the new clinical advisory board, in alphabetical order by last name.
  • Recent roles include Director of Laboratory Science at Palmetto's MolDX program, Chief Medical Officer and Clinical Laboratory Director of Freenome, and Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) member.

deepull appoints Kimberle Chapin, MD, as Chief Medical Officer and Wade Stevenson as Chief Marketing and Sales Officer

Retrieved on: 
torsdag, april 18, 2024

Barcelona, Spain – 18 April 2024 – deepull, a medical diagnostics company developing culture-free diagnostic solutions for rapid pathogen identification for sepsis and other acute infections, today announces the appointments of Dr Kimberle Chapin as Chief Medical Officer and Wade Stevenson as Chief Marketing and Sales Officer.

Key Points: 
  • Barcelona, Spain – 18 April 2024 – deepull, a medical diagnostics company developing culture-free diagnostic solutions for rapid pathogen identification for sepsis and other acute infections, today announces the appointments of Dr Kimberle Chapin as Chief Medical Officer and Wade Stevenson as Chief Marketing and Sales Officer.
  • Jordi Carrera, Chief Executive Officer and Co-Founder of deepull, said: “Kim and Wade are joining at an important time for the business as it progresses its automated sepsis diagnostic test.
  • Previously, Kimberle worked as Chief Medical Officer at Cepheid and for 17 years she was the Director of Clinical Microbiology and Molecular Diagnostics for Infectious Diseases for Lifespan Academic Medical Center.
  • The next few months will be important as we drive forward with the development of this rapid diagnostics solution and build out our commercial strategy,” commented Wade Stevenson, Chief Marketing and Sales Officer at deepull.

The Market and Future Potential for Molecular Point-of-Care (mPOC) Report, 11th Edition, with Profiles of 30+ Key Industry Players - ResearchAndMarkets.com

Retrieved on: 
onsdag, april 10, 2024

The "Market and Future Potential for Molecular Point-of-Care (mPOC), 11th Edition" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Market and Future Potential for Molecular Point-of-Care (mPOC), 11th Edition" report has been added to ResearchAndMarkets.com's offering.
  • Molecular point-of-care (mPOC) diagnostic solutions offer enhanced sensitivity and specificity compared to existing near-patient and rapid tests.
  • The Market and Future Potential for Molecular Point-of-Care (mPOC), 11th Edition, is a valuable resource for understanding the size and growth potential of the molecular POC market from 2023-2028. mPOC has transitioned from a novel trend to a significant contributor to the market.
  • What's the size of the Molecular Point-of-Care Market: 2023-2028
    Geographic Breakout of the Molecular Point-of-Care Market, 2023 (N. America, Europe, APAC, RoW)
    Segment Breakout of Molecular Point-of-Care Market, 2023 (Respiratory vs. Other)
    Near Patient Molecular IVD Market: 2023-2028
    Near Patient Molecular Market Share by Vendor, 2023
    Companies covered in this report, in profiles and/or product tables and market developments discussion include:

Danaher Reports First Quarter 2024 Results

Retrieved on: 
tisdag, april 23, 2024

WASHINGTON, April 23, 2024 /PRNewswire/ -- Danaher Corporation (NYSE: DHR) (the "Company") today announced results for the quarter ended March 29, 2024.

Key Points: 
  • WASHINGTON, April 23, 2024 /PRNewswire/ -- Danaher Corporation (NYSE: DHR) (the "Company") today announced results for the quarter ended March 29, 2024.
  • For the second quarter 2024, the Company anticipates that non-GAAP core revenue will be down mid-single digits year-over-year.
  • Danaher will discuss its first quarter results and financial guidance for the second quarter and full year 2024 during its quarterly investor conference call today starting at 8:00 a.m.
  • A replay of the conference call will be available shortly after the conclusion of the call and until May 7, 2024.

North America Molecular Diagnostics Market Size, Share & Trends Analysis Report 2024-2030: Growing Prevalence of Target Diseases & Increasing External Funding for R&D Fueling Expansion - ResearchAndMarkets.com

Retrieved on: 
tisdag, mars 26, 2024

Advancements in molecular diagnostic technology enabled the early detection of numerous diseases and reduced the possibility of severe economic & social burdens.

Key Points: 
  • Advancements in molecular diagnostic technology enabled the early detection of numerous diseases and reduced the possibility of severe economic & social burdens.
  • Molecular diagnostics enable early diagnosis of cancer, genetic disorders, and infectious diseases by using PCR, sequencing, & genetic technologies.
  • In addition, the increasing incidence of diseases, such as influenza A & B, is projected to drive market growth.
  • An increase in external funding to conduct clinical studies in molecular diagnostics is anticipated to fuel the market.

Cepheid Announces World Health Organization Prequalification of Xpert HIV-1 Qualitative Test

Retrieved on: 
onsdag, april 3, 2024

SUNNYVALE, Calif., April 3, 2024 /PRNewswire/ -- Cepheid today announced that Xpert® HIV-1 Qual XC has been awarded World Health Organization (WHO) prequalification. Inclusion on the prequalification list signifies that Xpert HIV-1 Qual XC meets WHO's stringent performance, quality, safety and reliability standards. Xpert HIV-1 Qual XC (extended coverage) is an in vitro nucleic acid amplification test for the qualitative detection of HIV-1 total nucleic acids directly from human dried blood spots and capillary or venous whole blood specimens.

Key Points: 
  • SUNNYVALE, Calif., April 3, 2024 /PRNewswire/ -- Cepheid today announced that Xpert® HIV-1 Qual XC has been awarded World Health Organization (WHO) prequalification.
  • Inclusion on the prequalification list signifies that Xpert HIV-1 Qual XC meets WHO's stringent performance, quality, safety and reliability standards.
  • The test has been cleared for use in early diagnosis of infants, adolescents, and adults at the point of care and in laboratories.
  • Xpert HIV-1 Qual XC is part of a comprehensive portfolio of WHO pre-qualified Xpert tests available internationally, including Xpert HIV-1 Viral Load, Xpert HBV Viral load, Xpert HCV Viral Load, Xpert HCV VL Fingerstick, and Xpert HPV, and WHO endorsed Xpert MTB/RIF Ultra and Xpert MTB/XDR.

Cepheid Receives FDA Clearance for Xpert® Xpress GBS

Retrieved on: 
måndag, mars 11, 2024

SUNNYVALE, Calif., March 11, 2024 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS). This next-generation test incorporates new dual targets in highly-conserved regions of the GBS genome to improve sensitivity and bacterial strain coverage. The test is designed for use on Cepheid's GeneXpert® systems.

Key Points: 
  • SUNNYVALE, Calif., March 11, 2024 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS).
  • Xpert Xpress GBS allows for the use of intrapartum direct PCR testing for women with unknown or unavailable antepartum GBS status.
  • With the capability of returning positive results as early as 30 minutes,2 Xpert Xpress GBS can provide real-time GBS status and inform decisions about empiric antibiotic prophylaxis if appropriate, to prevent GBS transmission during birth.
  • With Xpert Xpress GBS, Cepheid continues to provide fast, accurate, and reliable PCR solutions to facilitate evidence-based treatment and improved clinical care.

DiaCarta, Inc. and OncoAssure Ltd. Collaborate to Launch Prostate Cancer Lab Developed Test

Retrieved on: 
måndag, februari 26, 2024

The collaboration aims to leverage DiaCarta's expertise in customizable clinical diagnostic services to facilitate the completion of the Laboratory Developed Test (LDT) validation for the OncoAssure Prostate test.

Key Points: 
  • The collaboration aims to leverage DiaCarta's expertise in customizable clinical diagnostic services to facilitate the completion of the Laboratory Developed Test (LDT) validation for the OncoAssure Prostate test.
  • This partnership will expedite the validation process and pave the way for commercialization of the OncoAssure Prostate LDT test, benefiting healthcare providers and patients alike."
  • Dr. Adam (Aiguo) Zhang, CEO and President of DiaCarta, added, "We are very pleased to collaborate with OncoAssure to bring the best-in-class highly accurate OncoAssure Prostate LDT test to commercialization in DiaCarta's CAP/CLIA laboratory.
  • The unique OncoAssure Prostate prognostic test addresses an unmet need in prostate cancer management and is a valued addition to DiaCarta's portfolio of molecular diagnostic tests for cancer that includes tests for bladder and colorectal cancer."

Danaher Reports Fourth Quarter and Full Year 2023 Results

Retrieved on: 
tisdag, januari 30, 2024

WASHINGTON, Jan. 30, 2024 /PRNewswire/ -- Danaher Corporation (NYSE: DHR) (the "Company") today announced results for the fourth quarter and full year 2023.

Key Points: 
  • WASHINGTON, Jan. 30, 2024 /PRNewswire/ -- Danaher Corporation (NYSE: DHR) (the "Company") today announced results for the fourth quarter and full year 2023.
  • Non-GAAP core revenue decreased 11.5%, including a 4.5% non-GAAP base business core revenue decline.
  • For the first quarter 2024, the Company anticipates that non-GAAP core revenue will be down high-single digits year-over-year.
  • Danaher will discuss its fourth quarter results and financial guidance for the first quarter and full year 2024 during its quarterly investor conference call today starting at 8:00 a.m.

Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP

Retrieved on: 
torsdag, januari 18, 2024

SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60 minutes from a single specimen for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV). This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care. The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.

Key Points: 
  • SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP.
  • This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care.
  • The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.
  • For more information about Cepheid's Xpert Xpress MVP test, please visit Cepheid's website.