We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
    • Webinar Recordings
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Roche Introduces New Fertility Test

Roche Introduces New Fertility Test

September 18, 2014

Swiss diagnostics maker Roche said Thursday it has launched the Elecsys Anti-Müllerian Hormone fertility test in all countries accepting the CE mark.

The AMH blood test can be performed during any day of the menstrual cycle, providing superior results to conventional methods like follicle-stimulating hormone tests, which must be performed during certain times of the cycle, Roche said. It also produces standardized results, which are not achievable with ultrasound, since the assessment of ovarian reserve often depends on the operator or clinic, the company added.

Roche said it will use the AMH test in combination with a recombinant FSH test, which will allow for personalized dosing of human rFSH based on a woman’s specific AMH level — an improved option for couples looking to conceive via in vitro fertilization.

According to the World Health Organization, upwards of 80 million people are affected by fertility issues worldwide. The test is not yet available in the U.S. or Japan. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.

Devices Commercial Operations

    Upcoming Events

    • 30Nov

      Medical Device Cybersecurity: Latest Regulatory Developments

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 07Dec

      Proactive Supplier Management Using Quality Agreements

    • 13Dec

      FDA Inspection Overhaul: How Things Have Changed in 2023

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • Lilly’s Claims of Mounjaro Trademark Infringement Get ITC Investigation

    • Positive Findings Generated by Element Science’s Jewel Wearable Cardiac Defibrillator

    • Biden Offers Drug Supply Chain Fixes, but Think Tank Says Government Isn’t Doing Enough

    • FDA Gives Green Light to Medtronic’s Symplicity Renal Denervation System

    The Revised ICH E8: A Guide to New Clinical Trial Requirements

    Learn More
    • Drug Products
      • Quality
      • Regulatory Affairs
      • GMPs
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Device Products
      • Quality
      • Regulatory Affairs
      • QSR
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Clinical Products
      • Trial Design
      • Data Integrity
      • GCP
      • Inspections and Audits
      • Transparency
    • Privacy Policy
    • Do Not Sell or Share My Data
    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing