On September 23, FDA sent a letter to all manufacturers that received EUA authorization for COVID-19 tests, urgently notifies all these manufacturers of three new requirements for their EUA-authorized tests.

GE (NYSE:GE) has entered into an agreement to acquire BK Medical, a leader in advanced surgical visualization, from Altaris Capital Partners for a cash purchase price of $1.45 billion.

On September 26, Hangzhou Matridx Biotechnology Co., Ltd. (hereinafter referred to as Matridx) announced that it had completed a strategic investment of hundreds of millions of yuan.

Lucid Diagnostics on Thursday announced a proposed initial public offering of its common stock.

Zymo Research announced on Thursday that its EZ DNA Methylation-Lightning Kit has received CE marking.

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (“Mindray”) (300760.SZ), a leading global provider of medical devices and solutions, has completed its previously announced acquisition of HyTest Invest Oy and its subsidiaries (“HyTest”), a global leading provider of antibodies and antigens.

The agency is requiring test developers to monitor emerging mutations and their potential impact on the performance of authorized SARS-CoV-2 tests.

Investigators have determined that high-risk HPV DNA can be detected in saliva in most patients with HPV-driven oropharyngeal cancers at the time of diagnosis.

A large international collaboration led by researchers from the Johns Hopkins Kimmel Cancer Center has identified promising new targets for pancreatic cancer treatment and early diagnosis after examining various aspects of these tumors' genes and proteins.

Aplastic anemia (AA) is a life-threatening bone marrow disorder caused by the autoimmune destruction of hematopoietic stem and progenitor cells (HSPCs).

Roche said on Wednesday that three of its molecular respiratory panels have received CE marking and have been launched in countries accepting the CE mark.

Beijing Strong Biotechnologies, Inc. (BSBE. 300406) announced on the evening of September 21 that the company signed reagent purchase agreement with Roche Diagnostics (Shanghai) Co., Ltd.

The US Department of Defense announced on Friday that in coordination with the US Department of Health and Human Services it has awarded four procurement contracts totaling $647 million to four companies to purchase over-the-counter COVID-19 test kits.

DiaSorin Molecular announced on Monday that its Simplexa COVID-19 & Flu A/B Direct test has received CE marking.

On September 16, the selection results of the 4th China Quality Award were officially announced at the China Quality (Hangzhou) Conference. KingMed, BGI and Wego were awarded the nomination award of the 4th China Quality Award.

Prenetics, a Hong Kong-based genomic and diagnostic company, is going public through a merger with Artisan Acquisition, a special purpose acquisition company. According to the Wall Street Journal, the deal values the company at $1.25 billion.

Thermo Fisher Scientific said on Thursday that it has received CE-IVD marking for its TaqPath COVID-19 RNase P 2.0 kit, which has been designed to provide accurate results by compensating for current and future COVID-19 viral mutations.

Biotech companies Abacus Diagnostica, Kaivogen, and Labrox announced Tuesday that they are combining to create an in vitro diagnostics firm to develop near-patient antibody and PCR tests for infectious diseases and cancers that could be run from a single device.

Mesa Laboratories said on Tuesday that it has acquired mass spectrometry-based genetic analysis firm Agena Bioscience for $300 million in cash.

On September 16, Beijing Hotgen Biotech Co.,Ltd. stated that the company proposed to establish Beijing Yaojing Gene Technology Co., Ltd. with a joint investment of CNY100 million with Mr. LIN Changqing (Chairman of Hotgen) and Beijing Yaojing Enterprise Management Center.