EMA NewStem Files FDA De Novo Submission, Gets CE Mark for Stem Cell Mutational Analysis Software The NewStem Software Diagnostic Device screens human haploid embryonic stem cells for gene mutations involved in chemotherapy resistance. MGI Receives CE Mark, Regulatory Clearance in Asia-Pacific Countries for Several Sequencers The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US. Dako Declares CE Mark for PD-L1 Companion Diagnostic for Lung Cancer Immunotherapy The test will identify NSCLC patients with PD-L1 expression who are likely to benefit from Merck's Keytruda, which has received a positive opinion from European regulators. EMA Reviewing Ariad's Iclusig; Firm Presents Additional Data at ASH Meeting Premium The European Medicines Agency announced it would launch an in-depth review of the benefits and risks of the leukemia medicine Iclusig (ponatinib). Takeda, Zinfandel Evaluate Genetic Risk Algorithm Ahead of Alzheimer's Delay Study with Diabetes Rx Premium Originally published July 23. Oct 24, 2012 Boehringer Launches 'Let's Test' Campaign to Educate Healthcare Providers on NSCLC Biomarker Testing Premium May 2, 2012 After FDA Letter Seeking More Data, Lilly Won't Pursue CDx-Guided Erbitux in NSCLC in the US Premium Feb 22, 2012 Lab21 Offering Companion Testing to Personalize ALK Inhibitors for NSCLC Patients Premium Nov 30, 2011 CHMP Recommends Caprelsa Approval in EU on Condition AstraZeneca Conducts PGx Trial Premium Oct 26, 2011 PMC's Analysis of European Reimbursement Systems IDs Barriers to Adoption of Individualized Medicine Premium Oct 19, 2011 UK's NICE Cites Lack of Response Markers for BMS' Yervoy as Factor in Negative Recommendation Premium Aug 24, 2011 Stanford Spinout NuMedii Seeks Pharma Partners to Use PGx Repositioning Algorithm in Drug Pipelines Premium Aug 17, 2011 Pfizer Using Qiagen KRAS Test to Study Dacomitinib Head-to-Head Against Tarceva in NSCLC Premium May 18, 2011 Plexxikon, Roche File Rx/Dx Application for PLX4032, Cobas Mutation Test in Metastatic Melanoma Premium Feb 23, 2011 Finland Studying Genetics of Narcolepsy in Children Receiving GSK's Pandemic Flu Vaccine Premium Breaking News Cancer Prognoses Informed by Module-Based Approach, Study Finds People in the News at Illumina, Centogene, BioSkryb New Products Posted to GenomeWeb: Bio-Rad, BD, Analytik Jena, BioMérieux Genetic Technologies to Raise A$5M in Direct Stock Offering In Brief This Week: SD Biosensors, Meridian, Oncocyte, Opko Health, GeneDx, More The Scan Study Reveals New Details About Genetics of Major Cause of Female Infertility Researchers in Nature Medicine conducted a whole-exome sequencing study of mote than a thousand patients with premature ovarian insufficiency. Circulating Tumor DNA Shows Potential as Biomarker in Rare Childhood Cancer A study in the Journal of Clinical Oncology has found that circulating tumor DNA levels in rhabdomyosarcoma may serve as a biomarker for prognosis. Study Recommends Cancer Screening for Dogs Beginning Age Seven, Depending on Breed PetDx researchers report in PLOS One that annual cancer screening for dogs should begin by age seven. White-Tailed Deer Harbor SARS-CoV-2 Variants No Longer Infecting Humans, Study Finds A new study in PNAS has found that white-tailed deer could act as a reservoir of SARS-CoV-2 variants no longer found among humans.