Grail announced it will enroll about 6,200 people in an interventional, multi-center study evaluating its multi-cancer early-detection blood test. This is the first time health care providers will use this test to help guide patient care.
Grail Inc. is moving closer to its goal of developing a liquid biopsy test that can detect cancer early and help clinicians identify more appropriate treatments faster.
The company, a spin-off from Illumina Inc., announced on 18 February that the US Food and Drug Administration has given it the go-ahead to evaluate Grail's multi-cancer early-detection blood...
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
