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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
LDTs: FDA Cracks Down on Marketing of Non-Approved PGx Medication Response Tests
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Study Finds Liquid Biopsies More Effective than Traditional Biopsies in Detecting Cancer Drug Resistance
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Point of Care: Handheld Device Shows Promise in Detecting Concussion from Blood Samples
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FDA Watch: Agency Okays EIA Technology-Based Lyme Assays
From - National Intelligence Report
Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against…
Inside the Industry: Government Report Casts Doubt on Cost-Effectiveness of Leading Genetic Colorectal Cancer Screening Test
From - Laboratory Industry Report
Few of the newfangled consumer genetic testing products have had greater commercial success and…
Medicare Reimbursement: MIPS Bonuses Are Easy to Earn, IF You Can Get into the Program
From - Lab Compliance Advisor
On July 11, CMS announced the results of 2018, Year 2 under the Merit-based Incentive Payment System…
Genetic Testing: Multigene Panel Testing Detects Hereditary Risk Variants in Metastatic Breast Cancer Patients
From - Diagnostic Testing & Emerging Technologies
The clinical value of performing multigene panel for inherited cancer in patients with metastatic breast cancer has…
West Virginia Medicaid Recovers $17 Million for $8.5 Million Opioid Scam
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LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
From - National Intelligence Report
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict…
Adoption Quickening for Genomic Cancer Testing in Community Settings
From - Diagnostic Testing & Emerging Technologies
Clinicians are increasingly using genomic cancer testing in community health care settings, although there are…