US Food and Drug Administration officials said Wednesday that over-the-counter molecular assays could bridge gaps in monkeypox testing, as agency officials also continued work on creating guidance specific to antigen tests for the disease.

PerkinElmer subsidiary Oxford Immunotec said Thursday it gained US Food and Drug Administration approval for its T-Cell Select reagent kit that automates sample preparation steps for its tuberculosis in vitro diagnostic assay.

On September 21, 2022, Lepu Medical was officially listed on the SIX Swiss Exchange. It is a critical milestone in the development of Lepu Medical and a brand new point for the company's comprehensive internationalization strategy.

Roche announced on Tuesday that it is launching three new tests on its molecular Cobas 5800 instrument in countries accepting the CE mark.

At-home and point-of-care diagnostics company OraSure Technologies said Tuesday it secured a federal contract for up to 1 million of its OraQuick In-Home HIV Tests over five years.

Recently, Thermo Fisher Scientific signed a cooperation agreement with Guangzhou Economic and Technological Development Zone Administrative Commission, announcing that Thermo Fisher Scientific Guangdong-Hong Kong-Macao Greater Bay Area base will be established in the Guangzhou Development Zone.

ImmunoScape, a Singapore-based developer of immune profiling technologies, said on Tuesday that it has raised $14 million in new funding.

OpGen subsidiary Curetis announced on Tuesday a research and development collaboration agreement with FIND, the global alliance for diagnostics, to develop the Unyvero A30 RQ platform for use in low and middle income countries.

Suzhou 4a Biotech Co., Ltd. has recently completed a Pre-A round of financing of tens of millions (CNY).

Roche announced on Monday that its Cobas Pure Integrated Solutions instrument has received 510(k) clearance from the US Food and Drug Administration.

Cancer detection startup Naveris said Monday it has secured a $33.4 million expansion of its Series A financing round to reach a total investment in the firm of $51 million that will be used to commercialize and advance its early, viral-driven cancer detection tests.

The domestic in vitro diagnostic (IVD) leader in the post-epidemic era is targeting India, which is growing as fast as the Chinese market. Fapon Biotech has been deployed in the Indian market for nearly 15 years, and the in vitro testing raw materials have more than half of the local market share.

BriaCell Therapeutics said that it has signed an agreement with Caris Life Sciences to support patient identification and enrollment of genetically defined subgroups for a current Phase I/II clinical trial in advanced metastatic breast cancer.

Qiagen announced on Thursday that it has obtained the CE-IVD mark for RT-PCR assays to detect and quantify Epstein-Barr virus and human herpesvirus-6 on its NeuMoDx instruments.

At the beginning of this year, Roche Diagnostics China and Changchun Sunostik Medical Technology Co., Ltd. entered into a strategic partnership and jointly launched a new RS600 laboratory automated system for the Chinese market.