FDA Approval

Cancer is the second leading cause of death worldwide, with nearly 10 million deaths annually.1,2 In the U.S., approximately 1.9 million new cancer cases are expected to be diagnosed in 2021.1 Based on cancer biomarkers, the...

Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib) About 235,000 people in the US will be diagnosed with lung cancer...

Detection of BK virus in urine may be indicative of early infection in immunocompromised transplant patients Early detection is critical as complications due to infection after transplantation are one of the main causes of...

Health and Human Services (HHS) is seeking public comments on making permanent regulatory flexibilities provided during the COVID–19 public health emergency by exempting certain medical devices from premarket notification requirements;...

MEDIA RELEASE First commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample As COVID-19 and influenza infections can hardly...

MEDIA RELEASE Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV — from appropriate counseling on disease differences to...