The shortage of European notified bodies (NBs) for in vitro diagnostics has prompted calls from industry to delay the compliance dates for the In Vitro Diagnostic Regulation (IVDR), and the European Commission has responded with a proposed fix. The Commission proposed to give IVDs that are already on the market until May 2025 or later to obtain new CE marks, but the change requires the assent of the European Parliament and the European Council before it goes into force.

A pan-cancer liquid biopsy solution that was developed by Twist Bioscience Corp. and Anchordx Medical Co. Ltd. has been launched globally. The companies will market the Twist Alliance Pan-Cancer Methylation Panel (Pan-Cancer Panel) jointly. The Pan-Cancer Panel is a solution for pan-cancer study including DNA methylation library preparation and targeted enrichment for next-generation sequencing (NGS).

TORONTO – Radialis Medical Inc. has submitted FDA premarket notification for a positron emission tomography system (PET) that targets specific organs for low dose imaging and may be flexible enough to assess many different diseases. The Radialis PET camera is under clinical investigation at Toronto’s University Health Network and Princess Margaret Cancer Center for its ability to assess anomalies in breast cancer.

PERTH, Australia – Molecular diagnostic company Speedx Pty Ltd. has invested in a Perth-based startup that makes the raw materials needed for polymerase chain reaction (PCR) COVID-19 tests. The two companies will work to develop a new at-home rapid PCR test to ensure Australia can become self-sufficient with producing PCR tests. A rapid PCR test that gives an accurate result in minutes could be used at home or work.

Centogene NV and Twist Bioscience Corp. are linking up to develop custom assay kits for rare disease testing. The companies said the collaboration aims to make genetic tests more accessible to rare disease patients. Financial details were not disclosed. Centogene, which dubs itself the “rare disease company” is positioning to be a frontrunner in the testing market. The global rare disease genetic testing market size was valued at $812.3 million in 2019 and is projected to register a CAGR of 10.9% from 2020 to 2027.

Advocates have continued to press for more widespread use of rapid antigen tests in the home as a primary instrument for returning to economic normalcy, and the FDA has granted an emergency use authorization (EUA) to Acon Laboratories Inc., of San Diego, for the company’s Flowflex rapid antigen test for at-home use. According to the FDA, Acon said the COVID-19 test will be produced at a rate of 200 million a month by February 2022, a clip that should go a long way toward restoring vigor to a lagging U.S. economy.

The FDA has granted clearance of Siemens Medical Solutions Inc.’s photon-counting computed tomography (CT) scanner, Naeotom Alpha. The new diagnostic imaging device uses a photon-counting detector that measures individual X-rays that pass through a patient's body, as opposed to current systems that use detectors that measure the total energy contained in X-rays at once. The scanner then transforms the information from the X-ray photons into a detailed three-dimensional image, which can be used by physicians to assist diagnosis or treatment preparation planning.

A series A fundraising round lifted the mood at Genetikaplus Ltd. (Genetika+), raking in $10 million, a healthy 33% more than the initial target of $7.5 million. Proceeds from the round will go to fund trials of the Jerusalem-based company’s “brain-in-a-dish” technology for evaluating the best antidepressant for each patient. Greybird Ventures led the round, with participation by Meron Capital, Jumpspeed Ventures and Sapir Venture Partners.

A cloud-based web application for long-term brain monitoring has received a CE mark to support personalized management of neuro-disorders such as epilepsy. Developed by Swiss neuroscience research organization Wyss Center, Epios Cloud displays and reviews electroencephalogram (EEG) recordings made by EEG devices using scalp and sub-scalp electrodes, heart rate and accelerometer measurements.