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Oncologists were one of the few provider groups to register support for the FDA rule, reflecting the challenge of assessing ...
The San Diego-based firm said that it is transitioning beyond laboratory-developed tests and expanding access to its tests for the detection of early-stage cancers.
The company's next-generation sequencing-based test is used to aid the detection of cancers in patients with indeterminate lesions.
The UK government said that it plans this year to repeal regulations specific to COVID-19 tests as part of the alignment with EU Common Specifications.
NEW YORK – VieCure said Thursday that it has entered a strategic partnership with cancer genomic testing firm Guardant Health to embed Guardant's menu of precision oncology tests into the VieCure Halo ...
Investigators compared risk prediction using PathomIQ's platform to molecular test results, evaluating its ability to predict biochemical recurrence in high-risk patients.
The firms will distribute NowDx's First to Know test to more than 15 organizations nationwide, including LGBTQ+ health centers, HIV/AIDS care providers, and safety-net clinics.
The test is used for the detection of antibodies against Borrelia burgdorferi in serum from patients with signs, symptoms, and clinical history consistent with Lyme disease.
The test is covered for serial use in patients with colorectal cancer in the adjuvant and recurrence monitoring settings over a five-year period.
Health Canada has allowed the firm to bypass a requirement that tests be authorized for nonprofessional use prior to self-test authorization.