NEW YORK – Roche said this week that the US Food and Drug Administration has granted the company's Elecsys Galad score breakthrough device designation. The algorithmic score combines a patient gender’s and age, and the results of Roche’s Elecsys test for biomarkers AFP, AFP-L3, and PIVKA-II to aid in the diagnosis of early-stage hepatocellular carcinoma. Combined with ultrasound, the Elecsys Galad score can give clinicians accurate information at an earlier stage about a patient's disease, improving patient outcome and potentially reducing costs to healthcare systems, Roche said.
Chembio Diagnostics this week provided an update on its application to the US Food and Drug Administration for premarket approval of its DPP HIV-Syphilis Assay System. Chembio said that the FDA has confirmed that the syphilis arm of the study and results associated with the inclusion of pregnant women were acceptable. However, the FDA has requested the repeat of a reproducibility study, as one of the sites in the trial reported greater variability compared to the other sites.
Chembio said it has addressed and discussed with the FDA what it deems to be the underlying cause of the variance, and it has already initiated the reproducibility study. In parallel, the company has accelerated studies for a CLIA waiver for the test.
China’s General Administration of Market Supervision announced last week it has approved Danaher’s proposed $21.4 billion acquisition of GE’s Biopharma business. The decision follows last year’s EU approval of the deal, leaving the US Federal Trade Commission the last regulatory body to comment on the deal before it can close.
Arrow Diagnostics said this week that it has received the CE mark for two library preparation kits for bacterial 16S rRNA gene sequencing. The kits, AD4SEQ Microbiota Solution A and B (formerly called ArrowforNGS Microbiota Solution A and B), amplify the 16S hypervariable regions V1-V2-V3 and V3-V4-V6, respectively. They are designed to be used with the Illumina MiSeq sequencer and come with dedicated analysis and reporting software, MicrobAT.
Kiyatec said this week that the VA Portland Health Care System has joined the company’s 3D-PREDICT clinical study to validate Kiyatec’s test as a patient-specific predictor of response to cancer therapies in glioblastoma patients. 3D-PREDICT is a prospective, open-label, non-interventional study to validate Kiyatec’s glioblastoma drug response profile, which uses an ex vivo 3D cell culture platform to assess pre-treatment, patient-specific response to a panel of 12 drugs most commonly used to treat the disease.
Assistance Publique-Hôpitaux de Paris (AP-HP) and Median Technologies this week inked a collaboration agreement involving studies to validate Median’s iBiopsy platform, which consists of artificial intelligence-based qualification of diagnostic and prognostic imaging biomarkers. The agreement initially covers two joint clinical studies on liver cancer, involving coordinating investigators at Median and two AP-HP hospitals ─ Pitié-Salpêtrière and Paul-Brousse.
Financial and other terms of the agreement were not disclosed.
Using medical imaging, the first study aims to identify the phenotypic heterogeneity of liver cancer and its impact on the diagnosis and prognosis of patients. The second study will use retrospective data from a smaller and more targeted patient cohort to identify phenotypes of high-risk liver tumor recurrence, to improve the treatment and follow-up of high-risk patients.
Swedish medical imaging IT and cybersecurity firm Sectra said this week it has signed a contract with Geneva University Hospital to use the company’s digital pathology solutions, which have been integrated with GUH’s laboratory information system. The solution is vendor-neutral, allowing the hospital to select the whole-slide imaging scanner of its choice. The hospital, one of the five largest in Switzerland, handles about 35,000 pathology exams each year.
Separately, Sectra said it and University Medical Center Utrecht in the Netherlands are collaborating to accelerate clinical adoption of AI technology. AI applications from collaborating vendows will be integrated into the existing clinical workflow, Sectra said. Additional details were not disclosed.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.