Evidence map›Paper›PMID 39598157›Full record

ReviewLife (Basel, Switzerland)2024

Companion Diagnostics (CDx) Based on Molecular Biology Techniques.

Su Lim Kang, Ji Yean Kwon, Sung Min Kim

Abstract readReview
In one paragraph

Review in Life (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Su Lim KangDepartment of Medical Device and Healthcare, Dongguk University-Seoul 26, Pil-dong 3-ga, Jung-gu, Seoul 04620, Republic of Korea.ORCID 0000-0002-2096-8575
Ji Yean KwonDepartment of Medical Device and Healthcare, Dongguk University-Seoul 26, Pil-dong 3-ga, Jung-gu, Seoul 04620, Republic of Korea.
Sung Min KimDepartment of Medical Device and Healthcare, Dongguk University-Seoul 26, Pil-dong 3-ga, Jung-gu, Seoul 04620, Republic of Korea.ORCID 0000-0001-6457-989X

Funding

Ministry of Food and Drug Safety RS-2024-00331775
6 · The paper itself

Abstract

Molecular profiling based on genomic mutations provides clinically important diagnostic and prognostic information. Companion diagnostic (CDx) testing, which is based on targeted drug therapy, is being applied to a variety of molecular diagnostic techniques (e.g., fluorescent in situ hybridization-FISH; polymerase chain reaction-PCR; and next-generation sequencing-NGS) to diagnose complex etiologies using a minimal number of specimens, replacing immunohistochemical analysis, which may show bias at certain stages. The safety and effectiveness of CDx testing using molecular diagnostic technology in precision medicine is an important factor in determining the treatment outcome and prognosis of patients. Meeting minimum safety and effectiveness performance standards is essential for CDx testing, and a thorough understanding of regulatory considerations is necessary to plan and design the optimal product. In this review, we focus on the diagnostic field of precision medicine and discuss the safety and effectiveness that each molecular diagnostic technology must meet according to CDx testing diversity.

Indexed as

companion diagnosticseffectivenessmolecular diagnosisregulatorysafety

Identifiers

PMID39598157
PMCPMC11595734

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.