Emerging Technology

FDA approves Illumina IVD kit as CDx

By LabPulse.com staff writers

The U.S. Food and Drug Administration (FDA) has approved Illumina's TruSight Oncology Comprehensive cancer biomarker IVD kit for use as a companion diagnostic to match patients to two targeted therapies, Bayer's Vitrakvi and Lilly's Retevmo.

August 27, 2024

Danaher acquires Genedata

By LabPulse.com staff writers

The Basel, Switzerland-based Genedata, which develops software for biopharmaceutical and biotech R&D, said that it is joining Danaher's life sciences segment.

August 19, 2024

At-home heart failure screening device unveiled at ACS meeting

By LabPulse.com staff writers

A prototype heart-failure screening device that measures levels of two biomarkers for heart failure in as little as 15 minutes from a drop of saliva is being presented at the American Chemical Society (ACS) hybrid fall meeting.

August 20, 2024

Sophia Genetics platform receives CE Mark

By LabPulse.com staff writers

Software firm Sophia Genetics has received the CE Mark under the European Union's In Vitro Diagnostic Regulation for its Sophia DDM platform.

August 15, 2024

Thermo Fisher gets FDA 510(k) clearance for HLA typing CDx

By LabPulse.com staff writers

Thermo Fisher's SeCore CDx HLA A Sequencing System has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use as a companion diagnostic (CDx) with Adaptimmune's T-cell receptor therapy Tecelra for synovial sarcoma.

August 7, 2024

New laboratory developed tests for colorectal cancer screening get boost from CMS

By Liz Carey

Clinical laboratory test manufacturers aim for estimated 60 million unscreened Americans as CMS meets them with a broad CRC screening test definition and proposed coverage changes in 2025.

July 31, 2024

Sapio Sciences launches partnership program

By LabPulse.com staff writers

Lab informatics platform company Sapio Sciences has launched the Sapio Sciences Partner Program, a network of technology vendors, services companies, and resellers.

July 18, 2024

EnsoData adds Resonea technology to sleep apnea platform

By LabPulse.com staff writers

EnsoData has acquired sleep diagnostic technology from Resonea that will add acoustic flow and microphone channels to its platform.

July 11, 2024

Proscia 510(k) adds muscle to Siemens Healthineers' Syngo Carbon pathology module

By Liz Carey

Regulatory approval and integration of Proscia's Concentriq AP-Dx pathology module into Siemens Healthineers' Syngo Carbon digital workspace unlocks new possibilities and efficiency gains for labs, Proscia CEO David West tells LabPulse.com.

July 8, 2024

London hospitals grapple with fallout from pathology lab cyberattack

By LabPulse.com staff writers

South East London Integrated Care System called the situation a level 3 critical incident in relation to a cyberattack that has crippled the pathology laboratory's IT systems and significantly disrupted blood testing services.

June 21, 2024

Labcorp launches clinical trial solutions suite

By LabPulse.com staff writers

Labcorp has launched Labcorp Global Trial Connect, a suite of digital and data solutions aimed at increasing the speed of clinical trials at investigator sites.

June 20, 2024

Austrian hospitals onboard Sophia Genetics for blood cancer diagnostics

By LabPulse.com staff writers

The testing will not only help the local population but will provide valuable insights and data to support others using the platform around the world.

June 13, 2024

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