Foundation Medicine, Inc.

VectorY Therapeutics, a biotechnology company developing vectorized antibody therapies for neurodegenerative diseases, appointed Jessica Atkinson as Chief Business Officer in a newly created role.

Oligo Factory has launched a new low-scale oligonucleotide synthesis capability, enabling researchers to order custom DNA and RNA oligos in volumes as small as 50 nmol while maintaining high quality standards.

• The FDA has approved FoundationOne CDx as a companion diagnostic for tovorafenib (Ojemda) in pediatric low-grade glioma (pLGG) patients with specific BRAF alterations. • FoundationOne CDx detects BRAF fusions, rearrangements, and V600 mutations, enabling precise identification of pLGG patients who may benefit from tovorafenib treatment. • Tovorafenib received accelerated approval in April 2024 for relapsed/refractory BRAF-altered pLGG, supported by a 67% overall response rate in the FIREFLY-1 trial. • This approval marks Foundation Medicine’s first companion diagnostic indication exclusively supporting pediatric patients, enhancing precision medicine in pediatric oncology.

The global personalized medicine biomarkers market is projected to grow from $21.95 billion in 2024 to $79.26 billion by 2034, representing a CAGR of 13.7% as demand for precision healthcare solutions increases.

• The FDA has approved FoundationOne Liquid CDx as a companion diagnostic for tepotinib in metastatic non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping alterations. • Tepotinib, a targeted therapy, received traditional approval in February 2024 based on the VISION study, demonstrating an overall response rate of 51.4% and a median overall survival of 19.6 months. • FoundationOne Liquid CDx identifies genomic alterations in over 300 cancer-related genes, aiding in precision medicine for NSCLC patients who may benefit from tepotinib treatment. • The VISION study, which supported the approval, included patients who received tepotinib as both first-line and later-line therapy, showing durable responses and manageable adverse events.

The FDA has approved FoundationOne Liquid CDx as a companion diagnostic to identify metastatic non-small cell lung cancer (mNSCLC) patients with _MET_ exon 14 skipping alterations.

The FDA approved FoundationOne Liquid CDx as a companion diagnostic for tepotinib, aiding in identifying mNSCLC patients with MET exon 14 skipping alterations.

• The FDA has approved FoundationOne Liquid CDx as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib and fulvestrant. • This approval targets endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer patients after recurrence on or after adjuvant endocrine therapy. • FoundationOne Liquid CDx analyzes over 300 cancer-related genes from a blood sample, enhancing access to genomic testing for personalized treatment decisions. • Foundation Medicine now has seven companion diagnostic indications for breast cancer, leading in approved companion diagnostic indications for NGS testing.

Cellworks' biosimulation platform accurately predicted overall survival and chemotherapy benefit in two real-world NSCLC patient cohorts, advancing personalized cancer treatment beyond traditional PD-L1 biomarkers.

The FDA approved FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for olaparib plus abiraterone for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).