Use of these codes has frequently raised concerns for compliance due to a lack of clarity regarding when they’re appropriate.
New study shows that ctDNA liquid biopsy testing after stage II colon cancer may determine whether chemotherapy is required.
The owner, who also owned several telemarketing companies and committed tax evasion of just over $4 million, now faces 14 years in prison.
Revised guidelines from the American Urological Association support limited use of the tests for certain prostate cancer patients.
The move comes shortly after the FDA said it was going to decline some pre-submission requests to focus on pandemic-related diagnostics.
New research led by the American Cancer Society shows decreases in cervical and breast cancer screening during the pandemic.
Newly proposed legislation would establish a risk-based regulatory system for LDT regulation, though not everyone is happy with it.
For the first time, the FDA has granted emergency use authorization for a test to differentiate strains of the SARS-CoV-2 virus.
Three labs, their owner, two lab marketing companies, a fourth lab, and a physician are accused of kickbacks, money laundering, and fraud.
A new AI method developed by the National Cancer Institute could produce results similar to regular CT scans, but without exposing patients to radiation.
Effective June 1, the agency is once more accepting pre-submission requests for all in vitro diagnostics, including non-COVID-19 tests.
With threats and attacks increasing, Congress has tabled a bill that would impose extra penalties on those seeking to harm healthcare staff.
Researchers propose solutions to underrepresentation of certain groups in genetic databases, based on two recent initiatives.