FMT products now TGA registered as biologicals

Faecal Microbiota Transplant products are now being registered by the Therapeutic Goods Administration (TGA) as licensed biological products for therapeutic use  in Australia.

FMT products produced by the Centre for Digestive Diseases Pty Ltd are listed as Class 1 biological, comprising a faecal microbiota, frozen – L – Restoba; and a freeze-dried, encapsulated, frozen – L – Restoba formulation.

Another frozen FMT product, developed by Campbelltown Private Hospital, NSW, is also listed as a Class 1 biological.

Both products are listed as a faecal microbiota transplant (FMT) product indicated for the restoration of gut microbiota.

Under a new regulatory framework introduced in 2020, FMT product are to be registered as Class 1 biologicals if they are collected under the supervision of a medical practitioner and the manufacture is carried out in a hospital by, or under the supervision or direction of, the practitioner; and the product is for use in a recipient who is a patient of the hospital

New assay is better than FIT for CRC

A multitarget Faecal Immunochemical Test (mtFIT) has been developed with better diagnostic performance than FIT for colorectal cancer (CRC) screening, according to Dutch researchers.

In a validation study they compared a combination of haemoglobin, calprotectin, and serpin family F member 2 assay to a conventional FIT  assay in samples from 1038 people  from a CRC screening and 246 who were referred for investigation. With a control group of 769 participants for comparison, the study showed mtFIT to have a sensitivity for advanced neoplasia of 42.9% versus 37.3% for FIT (P = 0.025). Both tests had equal specificity of 96.6%.

For mtFIT the sensitivity for advanced adenomas increased to 37.8% compared to 28.1% with FIT (P = 0.006).

The better diagnostic accuracy in detecting advanced neoplasia provided a sound basis to pursue further development of mtFIT as a future test for population-based CRC screening, the study investigators said in Annals of Internal Medicine.

Mandatory vaccination call for all hospital staff

The Morrison government is being urged to make vaccinations compulsory for all hospital staff across Australia and have a roll out plan to provide vaccine every hospital worker.

The peak body representing Catholic not-for-profit hospitals, Catholic Health Australia (CHA), says the Federal government already has a mandatory vaccination scheme for aged care and should put in place a similar scheme for all hospital staff across Australia, public and private.

CHA says its hospitals are already redeploying unvaccinated staff to clinical areas where there is a lower risk of contact with COVID patients and vaccinating staff as and when Commonwealth supplies become available.

“Every year health care staff are required to get vaccinated against the flu and yet there’s no such directive for COVID,” said CHA’s Health Policy Director James Kemp.

National Cabinet should bring in a uniform rule for mandatory COVID vaccination for hospital staff – regardless of whether they work in ED, ICU or any other clinical or support position, he added.

“The high transmissibility of the Delta variant of COVID is putting workers and the people they care for at greater risk as well as putting extra strain on staff,” he said

Mr Kemp said: “Every worker should have a date in their diary to get vaccinated. Every dose that comes into the country should have a hospital worker’s name next to it.”