In August 2022 we have identified the following product launches and approvals that caught our attention from the diagnostics perspective. Check them out:
To meet the need for rapid genomic insights, Thermo Fisher Scientific launched the CE-IVD (IVDD) Oncomine Dx Express Test and Oncomine Reporter Dx for use in clinical labs.
2. Roche Gets Expanded CE Mark for Ventana PD-L1 Assay to ID NSCLC Patients for Tecentriq
Roche's Ventana PD-LD1 test has received a CE label expansion for its Ventana PD-LD1 SP263 test to determine NSCLC patients' eligibility for Roche's immune checkpoint inhibitor Tecentriq (atezolizumab).
The approval means that Guardant360 CDx, a next generation sequencing (NGS)-based assay that detects genomic alterations using circulating tumor DNA from blood, is validated as a CDx assay to identify NSCLC patients who have an activating HER2 mutation (SNVs and exon 20 insertions) and may benefit from treatment with ENHERTU
4. iRhythm, Alphabet unit Verily get FDA clearances for Zio Watch and software system
Google’s sister company Verily and iRhythm Technologies have received 510(k) clearance from the Food and Drug Administration for a new AI-powered smartwatch system to monitor cardiac arrhythmia, iRhythm said in a statement released on Friday. The approval covers both the Zio Watch, a new smartwatch developed by Verily and iRhythm, and the Zio ECG Utilization Software System, called Zeus.
5. Insulet’s Omnipod 5 insulin delivery system approved for preschool children
Insulet won an expanded indication from the FDA for the Omnipod 5 automated insulin delivery system, allowing it to be prescribed for children aged two years and older with Type 1 diabetes.
The ClarityDX Prostate® test provides patients and physicians with an accurate prediction of clinically significant prostate cancer to support decision-making and improve health outcomes for men suspected of having prostate cancer.
7. Viome Life Sciences launches at-home oral/throat cancer test for consumers
The saliva-based test has been found to have 95% specificity and 90% sensitivity. Consumers can purchase it online and have it shipped to their house.
8. Predicine Receives CE-IVD Mark for Blood and Urine Liquid Biopsy Assay
Molecular testing company Predicine's blood and urine cell-free DNA (cfDNA) assay, PredicineCare, has secured a CE-IVD mark.
9. Canhelp Genomics Secures NMPA Approval for Pan-Cancer Tissue-Origin Assay, Analysis Software
Chinese molecular diagnostics company Canhelp Genomics has received approval from China's National Medical Products Administration (NMPA) for its Canhelp-Origin pan-cancer test and companion analysis software.
10. Devyser's Fetal Test Gains IVDR Certification
Swedish diagnostics company Devyser said on Monday that its noninvasive prenatal test for prenatal aneuploidy analysis has been certified under Europe's new IVDR.