• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates
Home » Grail to debut multi-cancer blood test in Q2

Grail to debut multi-cancer blood test in Q2

January 11, 2021 By Sean Whooley Leave a Comment

Grail announced today that it expects to introduce its Galleri multi-cancer early detection blood test in the second quarter of 2021.

Menlo Park, Calif.-based Grail completed enrollment for the Pathfinder prospective study of Galleri in clinical practice just last month, according to a news release.

The 6,600-participant, multi-site, international study under an FDA investigational device exemption application has already completed its second planned independent data and safety monitoring board review and will have initial results, plus additional clinical validation data from a separate study, available in the first half of this year.

In combining the results from the Pathfinder trial with the foundational circulating cell-free genome atlas study, Grail expects the data to support Galleri’s introduction as a laboratory-developed test.

An earlier version of Galleri previously demonstrated the ability to detect more than 50 types of cancers (among which, 45 lack recommended screening tests today, the company said) with a low false-positive rate of less than 1%.

Grail also expects to be able to offer Galleri to eligible patients in the United Kingdom starting this year as part of a partnership with the UK National Health Service.

“Cancer remains the second-leading cause of death in large part because we lack recommended screening tests for the majority of deadly cancers. We are excited by the progress made in our mission to detect cancer earlier and what’s to come with the introduction of Galleri this year,” Grail CEO Hans Bishop said in the release. “We are encouraged by the significant early interest in Galleri from health systems, medical practices, and self-insured employers.”

Filed Under: Business/Financial News, Clinical Trials, Diagnostics, Featured, Food & Drug Administration (FDA), Oncology, Regulatory/Compliance Tagged With: Grail

In case you missed it

  • 6 questions about facial swelling and COVID-19 vaccines answered
  • DTW Podcast Ep. 42 – How the pandemic has accelerated, slowed medtech innovation
  • The top 5 MassDevice stories of the week — January 22, 2021
  • Intuitive Surgical stock down despite Street-beating Q4
  • FDA says to limit mask decontamination to 4 cycles
  • 5 innovations to make duodenoscopes more single-use — and save lives
  • FDA approves Boston Scientific Vercise Genus deep brain stimulation system
  • Johnson & Johnson vaccine trial results expected soon
  • 7 takeaways from Biden’s ‘full-scale, wartime’ plan to combat the COVID-19 pandemic
  • Canon Medical large bore CT wins FDA clearance
  • Amazon offers to help Biden administration with vaccine distribution
  • Biden’s COVID-19 response will make manufacturers busy
  • Mylan must face EpiPen racketeering lawsuit
  • Boston Scientific to acquire Preventice Solutions
  • Obalon Therapeutics’ stock skyrockets after announcing ReShape Lifesciences merger
  • EmblemHealth to provide coverage for Senseonics’ Eversense CGM
  • Abbott’s MitraClip receives boost as CMS expands coverage for TMVR

RSS From Medical Design & Outsourcing

  • January 2021 Issue: The Leadership in Medical Technology Issue
    9 lessons in crisis management from Stryker CEO Kevin Lobo These 10 stories mattered the most for medtech in 2020 How ResMed is advancing sleep and respiratory care How Dexcom CEO Kevin Sayer is leading the company forward Black engineers group works to promote diversity in medtech, equity in healthcare Taking the guesswork out of… […]
  • Olympus recalls thousands of endo devices due to packaging defect
    Olympus is recalling approximately 26,000 disposable EndoTherapy devices because of a packaging defect that could compromise their sterility. The announcement affects113 models distributed in the U.S.since early 2019, with different numbers of SKUs available in different regions worldwide. The company is asking customers to quarantine the devices until they can be shipped back to Olympus.… […]
  • FDA says to limit mask decontamination to 4 cycles
    Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times. The FDA began issuing emergency use authorizations (EUAs) for FFR decontamination systems with a range of allowable cycles and major… […]
  • 5 innovations to make duodenoscopes more single-use — and save lives
    Duodenoscopes are important medical devices that are used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, the devices have had serious problems in the past. Luckily, several medical device companies have stepped in to solve the problems. Duodenoscopes are flexible, lighted tubes threaded through the mouth, throat and stomach into the top of the small intestine.… […]
  • Plastic Molding Manufacturing adds 5 molding machines
    Plastic Molding Manufacturing (Hudson, Mass.) announced that it has added five new injection molding and two coordinate measuring machines in upgrades to its manufacturing and quality operations. The $1 million-plus investment will enable the custom molding company to distribute the pair of 214-ton machines, two 259-ton machines, and a 101-ton machine throughout its manufacturing network,… […]
  • CytoSorbents names former Integra exec to regulatory post
    Blood purification tech manufacturer CytoSorbents (NSDQ:CTSO)announced the appointment of David D. Cox as VP of global regulatory affairs. Cox was most recently VP of regulatory affairs for tissue and regenerative technologies at Integra LifeSciences (NSDQ:IART). He was responsible for regulatory approvals of new products and product extensions for the $480 million orthopedics and tissue technologies division.… […]
  • FDA clears Siemens’ radiography systems
    Siemens Healthineers (ETR: SHL) announced that the FDA has cleared its Multix Impact C ceiling-mounted digital radiography (DR) system as well as the Multix Impact VA20, a new version of the established floor-mounted parent DR system. The Multix Impact C and the Multix Impact VA20 were designed with an intuitive operating system, versatile wireless detectors, motorized tube… […]
  • 7 takeaways from Biden’s ‘full-scale, wartime’ plan to combat the COVID-19 pandemic
    President Joe Biden kept to his word to announce plans to “establish clear federal leadership” to tackle the coronavirus pandemic on his first full day in office. The White House issued a 200-page document on Inauguration Day detailing “full-scale, wartime” plans to harness the nation’s manufacturing and distribution capabilities to boost vaccine production, end shortages… […]
  • Qosina adds 12 new fluid and gas filters
    OEM single-use component supplier Qosina announced earlier this month that it added 12 new filter options for fluid and gas applications. Ronkonkoma, N.Y.-based Qosina’s filter product line includes offerings across a range of hydrophilic and hydrophobic filters, transducer protectors and an assortment of NRFit filters that are compliant with the ISO 80369-6 standard, according to… […]
  • OmniGuide launches surgical laser system fiber
    OmniGuide today announced the FDA clearance and commercial launch of its new OTO-U CO2 laser system fiber for use in ENT and otology surgery. The new fiber is designed to enable the surgeon to get into a tighter space with more precision and improve procedure outcomes, according to the Lexington, Mass.-based company. “OTO-U surgical fiber… […]
  • Biden’s COVID-19 response will make manufacturers busy
    Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its “full-scale, wartime” plans to combat the COVID-19 pandemic. In one of his first official acts as president, Joe Biden announced a plan to “fully use” the Defense Production Act to ramp up manufacturing of testing… […]

Reader Interactions

Leave a Reply Cancel reply

You must be logged in to post a comment.

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS