The U.S. FDA approved a supplemental NDA for Gilotrif (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test.
Consumers who search online for prices of common medical procedures may be disappointed by what they find, a U.S. study suggests.
A new blood test from Roche and Foundation Medicine has shown it can accurately measure the number of mutations within a tumor, potentially helping doctors predict which patients may respond best to some immunotherapies.
Quest Diagnostics Inc. will use a more precise method of calculating levels of “bad” LDL cholesterol that no longer requires fasting prior to blood draw, a development likely to delight patients who previously had to refrain from eating for up to 12 hours before testing.
PerkinElmer Inc. announced that it has entered into a definitive agreement to acquire EUROIMMUN Medical Laboratory Diagnostics AG. The agreement provides that PerkinElmer will acquire up to a 100% stake in EUROIMMUN.
Merck & Co.’s Keytruda became the first cancer drug FDA-approved based on a patients’ specific genetic traits regardless of where in the body the disease originated.
Theranos reached a settlement with the Centers for Medicare and Medicaid Services, which could make it eligible to operate a clinical lab within two years.
Officials in Washington, D.C.’s public health laboratory had to repeat Zika tests for nearly 300 pregnant women, including two women who were mistakenly told they tested negative for the mosquito-borne virus that has been shown to cause birth defects.
Theranos reportedly failed to notify patients in Arizona about potentially deficient diabetes tests.
Scientists in Britain have developed a type of HIV test using a USB stick that can give a fast and highly accurate reading of how much virus is in a patient’s blood.