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In-vitro diagnostic tests

09
Mar 2018

National Board of Health and Welfare do not recommend screening for prostate cancer with PSA samples with or without other supplementary tests before tissue sampling

According to the recommendation of the National Board of Health and Welfare (Socialstyrelsen), hospitals and clinics should not offer screening for prostate cancer with PSA tests with or without other supplementary tests before tissue sampling. The recommendation is based on that the benefit of screening for prostate cancer with PSA tests does not outweigh the negative effects on a population level.
23
Jan 2018

Med Tech-related technology assessments from NICE in the first half of January 2018

In the first half of January, the National Institute for Health and Care Excellence (NICE) published five new Medtech innovation briefings for in vitro diagnostic test for determining breast cancer subtypes, point-of-care creatinine tests before contrast-enhanced imaging, plasma EGFR mutation tests for adults with locally advanced or metastatic non-small-cell lung cancer, smartphone otoscope and sequencing panel for solid tumour cancers in children .
23
Nov 2017

Med Tech-related technology assessments from NICE in the first half of November 2017

In the first half of November, the National Institute for Health and Care Excellence (NICE) published two new interventional procedures guidance (for total distal radioulnar joint replacement in symptomatic joint instability or arthritis and extracranial to intracranial bypass in intracranial atherosclerosis), one new diagnostics guidance for tests to identify people at high risk of ovarian cancer and four new Medtech innovation briefings.
31
Oct 2017

G-BA wants to introduce newborn screening for Type I tyrosinemia by tandem mass spectrometry in the SHI in Germany

Following the request of a patient organization, the Joint Federal Committee (G-BA) evaluated the newborn screening for tyrosinemia type I by tandem mass spectrometry and decided to include the method into the relevant guideline. Before the method can be applied and reimbursed in the statutory health insurance (SHI) in Germany, the Genetic Diagnostics Act requires approval by the Genetic Diagnostics Commission (GEKO).
24
Oct 2017

Norwegian authorities have requested evidence submission from manufacturer of Prosigna test in relation to assessment for funding

In June of 2017, the Ordering Forum RHF commissioned rapid method assessment for the Prosigna test. Only when the Norwegian Institute of Public Health receives documentation from the suppliers they carry out a quick method assessment. On 16th of the October, suppliers were requested to submit data to the Norwegian Institute of Public Health (NIPH) regarding clinical efficacy, safety and economics of Prosigna test.
02
Oct 2017

Four decisions for medical devices and IVD tests from the meeting of the Norwegian Decision Forum on introduction of innovations in September

On 25th of September, the Norwegian Decision Forum of “New Methods” had a meeting to review several medical technologies and IVD tests. Decisions were made in relation to the introduction of 2 new newborn screening tests, prehospital emergency thoracotomy, aortic valve replacement using sutureless stent Perceval, and digital breast tomosynthesis.