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LDTs

Absent Resolution on FDA's LDT Oversight in 2022, Some Payors Began Advancing Their Own Requirements
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After the VALID Act didn't pass, it's uncertain how the FDA will proceed, though some payors aren't waiting for the status quo to change and asking labs to submit additional validation data on cancer tests.

Diagnostics Developer Early is Good Raises $4M in Seed Funding

The company will use the funds to complete clinical trials for its first product, BCDx, a laboratory-developed test for early bladder cancer detection.

South Korean Proteomics Firm Bertis Opening CLIA Lab in San Diego by End of Year
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The company will offer diagnostics including a test for the early detection of pancreatic cancer out of the lab as well as pharma research services.

Cofactor Genomics RNA-seq Assay Outperforms PD-L1 IHC to Predict Immunotherapy Responders
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The firm is aiming to commercialize its OncoPrism assay in 2023 as a laboratory-developed test to identify head and neck cancer patients eligible for checkpoint inhibitors.

Bionano Genomics Launches CLIA-Certified Laboratory, First OGM-Based Test

Bionano Laboratories will offer services to clinical customers seeking to implement OGM for routine diagnostic use.

Jun 13, 2022

At ESHG, Thermo Fisher Official Predicts IVDR Will Push Labs to Replace LDTs With Commercial Kits
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May 9, 2022

Artemis DNA to Provide Datar Cancer Genetics Liquid Biopsy Tests in the US, Vietnam Under $250M Deal

May 9, 2022

Guardant Health Confident in New CRC Screening Blood Test Despite Competitor Skepticism
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Mar 29, 2022

Genetron Health Q4 Revenues Up 10 Percent

Mar 25, 2022

ACMG Survey Finds Laboratory Geneticists Have Concerns Over Proposed Changes to LDT Regulation

Nov 18, 2021

Precipio Hematologic Malignancy Test Receives NY State Approval

Nov 15, 2021

FDA, HHS Update COVID-19 Test Emergency Use Authorization Policies

Nov 9, 2021

Invitae Unveils Plans to Expand Cancer Testing Portfolio
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Oct 11, 2021

EU IVDR Implementation Woes Could Severely Limit Cancer Companion Test, Precision Therapy Access
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Sep 21, 2021

Phosphorus Wins Conditional New York State Approval for GeneCompass Consumer Test

Aug 5, 2021

NYU Langone Health, Philips Integrate Informatics for FDA-Cleared Cancer Sequencing Panel
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Feb 25, 2021

Adaptive Biotechnologies Touts New Era of T Cell-Based Dx With T-Detect COVID Launch
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Nov 17, 2020

NanoString Technologies, OHSU Partner on Breast Cancer Spatial Protein Profiling Assay Development

Sep 10, 2020

FDA Joins PGx Collaborative Community but Effect on Field is Unclear
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Aug 28, 2020

Stakeholders Scramble to Predict Impact of HHS Move Limiting FDA Ability to Regulate LDTs
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Aug 20, 2020

HHS Says FDA Can't Regulate Lab-Developed Tests Without Notice, Comment Rulemaking

Mar 17, 2020

Fulgent Genetics, MedScan Laboratory Partner to Offer NGS Coronavirus Test

Mar 16, 2020

Coronavirus Testing Delays Yield New Oversight Bill, Shine Light on LDT Regulation Debate

Mar 5, 2020

FDA Defends Actions Against PGx Testing Labs As Necessary to Protect Public Health
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Jan 13, 2020

Adaptive Biotechnologies, Genentech Partner on MRD Testing in Venetoclax Clinical Trial

Breaking News
The Scan

Harvard Team Report One-Time Base Editing Treatment for Motor Neuron Disease in Mice

A base-editing approach restored SMN levels and improved motor function in a mouse model of spinal muscular atrophy, a new Science paper reports.

International Team Examines History of North American Horses

Genetic and other analyses presented in Science find that horses spread to the northern Rockies and Great Plains by the first half of the 17th century.

New Study Examines Genetic Dominance Within UK Biobank

Researchers analyze instances of genetic dominance within UK Biobank data, as they report in Science.

Cell Signaling Pathway Identified as Metastasis Suppressor

A new study in Nature homes in on the STING pathway as a suppressor of metastasis in a mouse model of lung cancer.