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Angle Gets FDA Clearance for Breast Cancer Cell Isolation System

NEW YORK — Angle said on Wednesday that its Parsortix cell sorting system has received US Food and Drug Administration clearance for use in the isolation of circulating metastatic breast cancer cells for liquid biopsy testing.

The FDA clearance "provides the platform for Angle to work with our collaborators and customers to support further FDA submissions and the establishment of numerous specific clinical uses across different cancer types," Angle Founder and CEO Andrew Newland said in a statement. "By making the Parsortix system widely available, we intend to support the entire industry in its adoption of liquid biopsy solutions for repeat noninvasive diagnostics for personalized cancer care. Large-scale medtech and pharma companies now have an FDA-cleared platform on which to develop new medical solutions."

Newland has previously said that Angle is also exploring the use of Parsortix in ovarian cancer and prostate cancer.

Angle said that the system received a De Novo Class II classification from the FDA, based on over 400 technical reports and documents and the processing of more than 16,000 samples to demonstrate its performance.

The UK-based company said it is also seeking CE-IVD marking for Parsortix.

The Scan

Nature Papers on Long Reads for Bacterial Genomes, Zebrafish Atlas, Hypothalamic Aging in Mammals

In Nature this week: near-finished microbial genomes without polishing, zebrafish functional annotation program, and more. 

Rise of BA.5

The New York Times reports that the Omicron subvariant BA.5 has become the dominant version of SARS-CoV-2 in the US.

UK Health Secretary Resigns

Sajid Javid, the UK health secretary, resigned along with Chancellor Rishi Sunak, saying they cannot work with Prime Minister Boris Johnson's government, CNN reports.

Clones From Freeze-Dried Cells

A team in Japan has cloned mice from freeze-dried skin cells, according to the Guardian.