As if it were needed, Amicus Therapeutics Inc.’s spin-off of its gene therapy work and PDUFA VII’s provisions to increase the capacity of the FDA’s Center for Biologics Evaluation and Research offered further proof this week of the global explosion that’s happening in the regenerative medicine field.

The EU’s Medical Device Regulation is now in full implementation mode, but the In Vitro Diagnostic Regulation (IVDR) won’t kick in until May 2022. Oliver Bisazza, director general of Medtech Europe, said that only six notified bodies are currently certified to review IVDs under the new regulatory framework, a predicament which suggests that many these tests will never again be available to patients.

Nonagen Bioscience Corp. received FDA breakthrough device designation for its liquid biopsy assay designed to predict response to treatment for bladder cancer. The test, Oncuria, measures 10 protein biomarkers in a urine sample and uses an algorithm to predict whether patients will respond to Bacillus Calmette-Guerin (BCG), the first-line treatment for bladder cancer, or should proceed to another treatment option.

Selux Diagnostics Inc. has received breakthrough device designation from the FDA for its Next Generation Phenotyping (NGP) platform for positive blood culture and sterile body fluid samples. The NGP technology is a diagnostic platform designed to help with the delivery of personalized antimicrobial therapies within 24 hours. The Boston-based company is hoping the technology can tackle the global antibiotic resistance crisis. According to the World Health Organization, antimicrobial resistance is one of the top 10 global public health threats facing humanity.

PERTH, Australia – As Australia prepares to reopen the country after strict lockdown measures, the TGA is making a new regulation to allow companies to supply their COVID-19 rapid antigen self-tests for home use beginning Nov. 1. “There’s light at the end of the tunnel for Australians on a number of fronts,” said Health Minister Greg Hunt in a Sept. 28 press conference.

TORONTO – Health Gauge Inc. (HG) and AI-on-Call Inc. will soon deploy a digital remote patient monitoring solution for early prediction of sepsis at three seniors' facilities located in British Columbia. HG’s smartwatch and AI-driven cloud platform capture an array of vital signs data, including blood pressure, heart and respiratory rates, and will be supported by AI-on-Call software that alerts medical staff to early signs of sepsis and acute illness.

The issue of FDA regulation of lab-developed tests (LDTs) has been percolating for a number of years, but the Verifying Leading-edge IVCT development (VALID) Act of 2021 appears to offer the solution. Several stakeholders, including Jeff Allen, president and CEO of Friends of Cancer Research, are eager to see the reforms come through quickly, given the increasingly vital role that tests such as companion diagnostics play in the care of patients facing potentially deadly diseases.

PERTH, Australia – Atmo Biosciences Ltd. has closed an oversubscribed AU$9.6 million (US$7 million) capital raise that will allow it to further develop its gas-sensing capsule for monitoring the health of the gut and the microbiome. Until now, there has not been a diagnostic test that can measure gases in the gut in vivo.

Clinicians may soon be able to identify wounds likely to have difficulty healing before they deteriorate thanks to the FDA’s 510(k) clearance for Moleculight Inc.’s i:X imaging device for detection of wounds containing high levels of Pseudomonas aeruginosa (PA). The point-of-care i:X visualizes fluorescence, with wounds containing elevated levels of PA glowing cyan.