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.

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.

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

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

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.

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 ...

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 ...

NEW YORK – Drawing on its longstanding partnership with Becton Dickinson, Babson Diagnostics is aiming to further expand use of its US Food and Drug Administration-cleared blood collection system ...

Recent study results show that the single-target DNA methylation test performed with a negative predictive value of 97.6 percent.

The prognostic test stratifies hospitalized women with hypertensive disorders of pregnancy into low- and high-risk categories for developing severe preeclampsia.