FDA

Alfa Scientific's iFOB test identifies human blood in feces, which may be a symptom of precancerous polyps and colorectal cancer.

The investment bank gave the company's stock an Outperform rating with a target price of $90 per share.

The test from Banyan Biomarkers called the Brain Trauma Indicator measures the levels of the proteins UCH-L1 and GFAP that are released into the blood.

The company has also developed two liquid biopsy cancer test, Liquid GPS Core for DNA and Liquid GPS Expression for RNA.

BMS amended an ongoing Phase III study of Opdivo and Yervoy to evaluate outcomes based on tumor mutational burden using Foundation Medicine's NGS companion diagnostic.

The Sentosa SA201 HSV-1/2 PCR test detects herpes virus DNA from oral or anal skin lesions in symptomatic patients.

Centogene opened a Boston office in December and plans to open a lab there in a few months as it awaits an FDA decision on its clinical tool.

The group of regulatory authorities from around the world has proposed a new guidance for harmonizing the procedures for assessing medical devices, including IVDs.

The clinicals labs contributing to the database are adding more case-level data and focusing on outlier interpretations.

The agency cleared the company's C-reactive protein, which is based on its Multi-Array technology used by life science researchers for 20 years. 

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