Genetic tests

On April 21, 2022, NHS England and NHS Improvement updated the 2021/22 National Genomic Test Directory (version 3), which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. Forty-two new codes (test-indication combinations) were introduced in the cancer field, and fourteen for rare and inherited diseases.

A new test called Genedrive System to detect babies at risk of gentamycin-related deafness was developed at the University of Manchester, funded by the National Institute for Health and Care Research (NIHR). On April 02, 2022, NHS England and NHS Improvement announced that Genedrive is now fully CE certified to be used in a clinical setting. The test is expected to be implemented in routine care in all NHS Manchester Foundation Trust hospitals within several weeks.

In March 2022, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (endoscopic balloon dilation for subglottic or tracheal stenosis, intramedullary distraction for lower limb lengthening, endoscopic full thickness removal of gastrointestinal stromal tumors of the stomach, percutaneous insertion of a cystic duct stent after cholecystostomy, and liposuction for chronic lipoedema), four new Medical Technologies Guidance (myCOPD, UroShield, Prontosan for wounds, and 3C Patch for diabetic foot ulcers), one new Diagnostic Guidance (terminated assessment of Freelite assays for multiple myeloma), and six new Medtech Innovation Briefings (Genedrive MT-RNR1 ID System, icobrain for multiple sclerosis, Al for analyzing chest X-ray images, and others). Also, three new clinical guidelines were published, and six were updated.

On February 21, 2022, it was announced by the Ministry of Health that the public consultation regarding the Draft Order amending the Common Package of Benefits of the National Health System (SNS) was open. The amendments and clarifications are related to the fields of in-vitro diagnostics, ENT, pulmonary and airways, e-health, neurology, dental care, radiology, and enteral nutrition.

The Council for Choices in Health Care in Finland (PALKO) has discontinued the development of recommendations concerning companion diagnostic tests. The respective preparations were completed in November 2021.

The Council for Choices in Health Care in Finland (PALKO) has initiated the development of recommendations concerning companion diagnostic tests. The respective preparations were completed in November 2021.

In August 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (magnetic resonance therapy for knee osteoarthritis, laparoscopic removal of uterine fibroids with power morcellation, hysteroscopic mechanical tissue removal for uterine fibroids), and six new Medtech Innovation Briefings (PLASMA system with button electrode, Immunoscore, MMprofiler, Patient Status Engine, lung texture analysis, Colli-Pee). Also, five clinical guidelines were published.

In August 2021, NHS announced rolling out genetic testing for monogenic diabetes and placental growth factor (PLGF) testing to rule out pre-eclampsia. These decisions are made in line with the NHS Long Term Plan committed to increasing access to genomic testing, improving diabetes care across the country, and investing in cutting-edge technologies.

On July 7, 2021, a Decree which defines the new annual budget of €20 million for breast cancer genomic tests has been published. The Decree describes the access procedure and the requirements for the disbursement of the budget. This Fund will provide “free” access to genomic testing to women from all Italian regions who could benefit from the testing.