HONG KONG – In vitro diagnostic company Cube Bio Co. Ltd., of Seoul, South Korea, has inked an agreement worth KRW3 trillion (US$2.5 billion) with Moscow-based Standart-Biotest LLC to export its cancer self-diagnostic kits for five years to Russia and the Commonwealth of Independent States (CIS).

PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is seeking comments from stakeholders on whether certain self-testing in vitro diagnostics (IVDs) should be prohibited from being sold to consumers.

A large-scale U.K. clinical trial of a portable electronic nose device has shown it is possible to distinguish bacterial from viral infection in an unselected population of patients presenting with a respiratory tract infection (RTI) symptoms, at the point of care.

Healthy.io had plenty of news to report last week. To begin, the Tel Aviv, Israel-based company, which is focusing on turning the smartphone camera into a clinical-grade medical device, now has a second clearance. In addition, the company closed a $60 million series C funding round.

The FDA granted breakthrough device status to Prescient Metabiomics' Lifekit Prevent colorectal neoplasia test. Prescient Metabiomics is a subsidiary of Carlsbad, Calif.-based Prescient Medicine Holdings Inc.

Royal Oak, Mich.-based liquid biopsy startup Oncocell MDx Inc. reeled in $22.2 million in a series B financing led by Savitr Capital, with participation from existing investors. The company, which has raised a total of $30 million to date, plans to use the proceeds to support ongoing development of its pan-disease immunogenomics platform and commercialization of its novel noninvasive blood-based tests.

There have been three oncology drug approvals by the U.S. FDA over the last few years that were based solely on a genetic biomarker, rather than the location in the body where the tumor originated. But to make this tissue-agnostic approach a reality for oncology patients, detecting those genetic biomarkers will have to become increasingly easy and standardized.