The companies have been collaborating on the development of Kryptos' molecular tests, and Osang led Kryptos' $10 million financing round in 2024.

The Amsterdam-based company recently received IVDR certification for other tests including one for phenylketonuria.

CMS officials said they have implemented national controls and sought repayment from dozens of healthcare providers and suppliers.

The PCR-based point-of-care assays, which return results within 20 minutes, have received regulatory approval from the US Food and Drug Administration earlier this year.

In particular, the cuts could hurt the FDA's efforts to scale up its expertise and review capabilities in emerging areas like digital- and AI-based devices.

The company aims to soon launch two tests to aid the treatment of dermatomycosis and is developing other tests for healthcare ...

The firm plans to use the proceeds to support its commercialization and R&D activities as well as for working capital and general corporate purposes.

Ares Credit funds served as the administrative agent on the incremental debt financing, which is intended to support Tempus' acquisition of Ambry Genetics.

The patent covers methods, systems, compositions, and kits for the multiplexed detection of analytes in a sample.

Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use. The single-use blood ...

Following a delisting decision by the Nasdaq Hearings Panel, the firm laid off its workforce and agreed to pay top executives for part-time consulting work.

According to the DOJ, a jury found that New York City-based Alexander Baldonado received tens of thousands of dollars in illegal cash kickbacks and bribes in exchange for ordering genetic cancer tests ...