BioNTech Qiagen to Develop Companion Diagnostic for BioNTech Head, Neck Cancer Treatment The test will identify patients with squamous cell head and neck cancer caused by specific HPV infections for treatment with BioNTech's investigational BNT113. BioNTech Gathering Data Supporting MammaTyper Over Manual, Digital IHC for Breast Cancer Subtyping Premium The new data supports the continued marketing of BioNTech's breast cancer subtyping assay as an alternative to IHC, and suggests added value for the test in assessing Ki-67 specifically. Genentech, BioNTech Deal Pushes Personalized Cancer Vaccines Toward Market Premium The two partners hope to start a Phase I combination trial pairing Genentech's anti-PDL1 cancer immunotherapy Tecentriq with vaccines developed using BioNTech's IVAC Mutanome. BioNTech Inks $310M Personalized Cancer Vaccine Deal With Genentech The deal will leverage BioNTech's IVAC Mutanome platform, which uses next-generation sequencing to identify targets for personalized mRNA-based vaccines. China FDA Grants Expedited Review to MammaTyper Breast Cancer Dx The diagnostic, a real-time PCR kit for breast cancer stratification, is being reviewed under a special process for the approval of innovative products. Breaking News Compact Gene Editing Enzyme May Improve Success Rates of Gene Therapies People in the News at Veracyte, Invitae, Mount Sinai, InterVenn Biosciences, Applied BioCode, More New Products Posted to GenomeWeb: Qiagen, IDT, Revvity, Mission Bio, NRichDx, More FDA Releases Proposed Rule for Oversight of Laboratory-Developed Tests CStone Pharmaceuticals, Genetron Companion Diagnostic Receives NMPA Approval The Scan Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants. Small Study of Gene Editing to Treat Sickle Cell Disease In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms. Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema. Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.