Ongoing health technology assessments related to in-vitro diagnostics by NICE in England

The Diagnostic Guidance (DG) program focuses on evaluating innovative medical diagnostic technologies to ensure that the NHS can adopt clinically and cost-effective technologies rapidly and consistently.

As of June 08, 2021, two DG concerned in-vitro diagnostics (IVDs) are in development with the scheduled publication date, and four assessments – without the scheduled date:

• EarlyCDT Lung for lung cancer risk classification of indeterminate pulmonary nodules. EarlyCDT Lung is a blood test, which measures seven autoantibodies produced in response to tumor-associated antigens related to lung cancer. The test uses a standard enzyme-linked immunosorbent assay (ELISA). The expected publication date is February 23, 2022;
• PlGF-based testing to help diagnose suspected pre-eclampsia. NICE will assess the clinical and cost-effectiveness of the Triage PlGF test, Elecsys immunoassay sFlt-1/PlGF ratio, DELFIA Xpress PlGF 1-2-3 test (with or without DELFIA Xpress sFlt-1 test), and BRAHMS sFlt-1 Kryptor/PlGF plus Kryptor PE ratio when used in addition to clinical assessment for the diagnosis of pre-eclampsia in the second and third trimesters of pregnancy. The expected publication date is November 17, 2021;
• PredictSURE IBD and IBDX to guide treatment of Crohn's disease, which is a whole blood-based biomarker prognostic test combined with a proprietary algorithm to produce a risk categorization (high- or low risk). The IBDX is a panel of six indirect solid-phase enzyme-linked immunosorbent assay (ELISA) kits measuring levels of anti-glycan antibodies in human serum. The publication was postponed without the scheduled date;
• Exploratory economic modeling of SARS-CoV-2 viral detection point of care tests and serology tests. NICE is assessing the clinical and cost-effectiveness of the point-of-care testing to help detect SARS-CoV-2, compared laboratory-based testing or no testing. The publication is postponed without a scheduled date;
• Multiple myeloma and related disorders - Freelite assays (and alternative technologies identified during scoping) for diagnosis in primary care. The publication date is not scheduled yet;
• Quantitative faecal immunochemical tests to guide colorectal cancer pathway referral for people with a change in bowel habit or abdominal pain. The publication date is not scheduled yet.

MedTech Innovation Briefing (MIB) is the advice program of NICE for innovative technologies. It provides an overview of clinical effectiveness, safety, and cost. It does not offer formal guidance, and it, therefore, does not provide any recommendations.

As of June 08, 2021, three MIBs concerned IVDs are in development with the scheduled publication date, and one without the scheduled publication date:

• Immunoscore for predicting the risk of relapse in patients with colon cancer by measuring the host immune response at the tumor site. The expected publication date is July 13, 2021;
• MMprofiler a prognostic test to determine the risk of a multiple myeloma patient by classifying such patient into a "high" or "standard" risk group with the use of the well-validated SKY92 gene signature. The expected publication date is July 06, 2021;
• clonoSEQ Assay for detecting and monitoring minimal residual disease (MRD) in patients with multiple myeloma, B-cell acute lymphoblastic leukemia, and chronic lymphocytic leukemia. The expected publication date is August 10, 2021;
• Trublood-prostate for triaging and diagnosing people with symptoms of prostate cancer. The publication date is not scheduled yet.

See the full details here.

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