NEW YORK – The US Department of Justice on Thursday said that Magellan Diagnostics has been ordered by a federal court to pay $42 million on charges that the company concealed malfunctions in ...

The test is approved for patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.

The researchers used the CellSearch assay to measure circulating tumor cells and determine the response to certain treatments as well as survival outcomes.

The Maryland-based firm reported in a recent proof-of-concept study that It used protease biomarkers to identify patients ...

NowDx's First to Know Syphilis Test received FDA authorization in August, making it the first over-the-counter syphilis test to be authorized by the agency.

Deck: Xgenera has also closed a round of seed financing worth £500,000 and commenced a partnership with YouSeq, a UK technology firm.

The San Francisco-based firm will use the proceeds to accelerate commercialization of its Intellisep rapid sepsis test.

The agreement's goal is to bring a blood-based test to market to stratify patients with traumatic brain injuries.

The governmental funding will support the company's plans for a 1,350 participant trial that aims to further validate its protein-based cancer early detection assay.

CyPath Lung is a laboratory-developed assay that uses self-collected sputum samples treated with a fluorescent compound that preferentially binds to cancer cells and cancer-related cells, San ...

The US Food and Drug Administration granted marketing clearances for multiple infectious disease tests and a blood culture sample preparation system, among other devices.

The round, which was led by Formation Venture Engineering, will support commercialization of the company's SAAmplify-ɑSYN biomarker test as well as increased R&D.