A menstrual pad designed with a removable strip to collect blood samples for clinical tests has been granted clearance by the US Food and Drug Administration (FDA).

DiaCarta announced on Tuesday that its over-the-counter fecal occult blood test has received 510(k) clearance from the US Food and Drug Administration.

Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA.

U.S. genetic testing company Illumina (ILMN.O) has been ordered by EU antitrust regulators to sell cancer test maker Grail (GRAL.O) after it completed the deal before securing their approval.

Labcorp (LH.N) on Wednesday began marketing to U.S. physicians the first test for a trio of blood biomarkers it says can detect the hallmarks of Alzheimer's, accelerating diagnosis of the brain-wasting disease and potentially helping patients access treatment.

Laboratory services provider Stone Diagnostics will offer Fibronostics' artificial intelligence-based liver disease test to physicians in the US, the companies announced on Tuesday.

Today, Sanguina, Inc. (Sanguina), a leading biotech company, is pleased to announce the FDA clearance of AnemoCheck Home, the only FDA-cleared home hemoglobin test kit available in the United States.

Experts have raised concerns about Quest Diagnostics’ $399 consumer-initiated Alzheimer’s disease test, telling 360Dx that it is unclear whether the product is accurate enough to support its use.

Mirxes, a Singapore-headquartered developer of RNA-based tests for the early detection of cancer and other diseases, said this week that it has recently signed two agreements that will help advance the company's commercial push into China and Indonesia.

The Alzheimer’s disease blood test developer C2N Diagnostics has released a new version of its screener for beta amyloid proteins, and it’s gearing up for a nationwide rollout as public hopes rise for treatments that may make some headway against the condition.