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The agency cleared a handful of assays last month for the detection and diagnoses of toxoplasmosis, syphilis, sepsis, thyroid conditions, and other ailments.
The IHC test was used in clinical studies that led to Zykadia's approval last week as a first-line option for metastatic NSCLC patients with ALK rearrangements.
Roche's Bluetooth-enabled meter gives patients the option to bypass frequent trips to the clinic in favor of doing anticoagulation testing at home.
Collaborators have created an atlas that compares available PD-L1 IHC assays and reveals areas of debate, including challenges encountered by clinicians.
A CE-label expansion extends the assay's application to patients being considered for Merck's Keytruda immunotherapy as the first line of treatment.
The Ventana PD-L1 assay was approved as a complementary diagnostic for bladder cancer patients being considered for treatment with the immunotherapy Imfinzi.
Since April 1, noninvasive prenatal testing, provided by three university genetic centers, is available to all pregnant women in the Netherlands for €175 as part of the TRIDENT-2 study.
Researchers said that laboratories participating in BRAF proficiency testing include most of the required reporting elements "to unambiguously convey molecular results."
While molecular testing is now routine in cancer and women's health, for other disease areas, the technology may be overkill, Sundin said.
Centralized and point-of-care division sales contributed most to the revenue growth, and were spurred on by a 13 percent lift in immunodiagnostics revenues.