Industry Articles
Embark on a journey into the world of Laboratory Developed Tests (LDTs) with 'LDT Industry Articles'. Explore the innovative wonders forged in laboratories, where scientists and researchers creatively redefine diagnostic testing.

Regulatory insights

•May 11, 2024

FDA issuing Final Rule on regulating LDT

•April 7, 2024

Concerns Expressed in Public hearing Surrounding FDA’s Regulation of Lab Developed Tests (LDTs)

•March 6, 2024

The EU has finally designated 5 IVDR reference laboratories

Emerging field insights

•April 17, 2024

Roche receives FDA Breakthrough Device Designation. Why is pTau-217 is becoming a hot biomarker for Alzheimer’s Disease?

•March 29, 2024

No longer eliminated, measle cases rise during post-COVID period

•March 7, 2024

Tempus Labs Optimistic on MRD, Invests in and Assists Personalis in Commercialization

Innovations

•May 20, 2024

A safe and inexpensive innovative blood sampling device developed by ETH Zurich

•April 29, 2024

Molecular You Discloses Significant Advancement in Early Pancreatic Cancer Detection

•April 28, 2024

Urine Analysis Reveals DNA Emanating from HPV+ Head and Neck Cancer Tumors

Latest Approved Products

•April 30, 2024

Pillar Biosciences’ OncoReveal CDx Test Receives Expanded FDA Approval

•April 28, 2024

Scopio Labs Gets FDA Clearance for Digital Bone Marrow Aspirate Application

•April 17, 2024

Roche CDx for Enhertu in Breast Cancer Nabs CE Mark

Leading lab updates

•May 13, 2024

Quest Diagnostics to Acquire PathAI Diagnostics to Accelerate AI and Digital Pathology Adoption in Cancer Diagnosis

•April 10, 2024

Quest Diagnostics’ blood test has been shown to potentially reduce the need for PET imaging of patients with Alzheimer’s disease

•March 9, 2024

Labcorp to acquire a portion of the assets of Legacy Health

Coverage Payment Insights

•March 7, 2024

Natera’s transplant testing assay, Prospera Lung, meets the coverage requirements of CMS, signaling the increasing maturation of the transplant monitoring market

•February 25, 2024

CareDx has its monitoring tool for lung transplant rejection covered by CMS

Investment

•April 30, 2024

Owlstone Medical Secures Funding from the Gates Foundation for Breath-Based Disease Detection

•April 28, 2024

Scout Secures Funding to Combat Antibiotic-Resistant STIs

•April 10, 2024

Eurofins Expands Renal and Transplant Testing Offerings with Ascend Clinical Acquisition

Collaborations

•March 7, 2024

Oxford Nanopore collaborates with Day Zero Diagnostics to develop an instant sepsis diagnosis solution

•March 1, 2024

Guardant Health Partners with Cancer Research UK to Advance Cancer Detection

•October 10, 2023

Foundation Medicine and Natera introduce a personalized tissue-based ctDNA test for monitoring cancer patients’ responses to treatment

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