Guardant Health received FDA approval for its Guardant360 Liquid CDx test, an expanded liquid biopsy panel that is now the largest FDA-approved in its category. The test evaluates a genomic footprint 100 times wider than the previous version, combines genomic and epigenomic insights from a single blood sample, and can deliver results in as little as seven days. The approval transfers seven previously approved companion diagnostic indications from the earlier Guardant360 CDx test. Shares rose 8.81% following the announcement.

The global colorectal cancer diagnostics and therapeutics market is projected to grow from USD 35 billion in 2025 to USD 73 billion by 2034 at a CAGR of ~9%. Growth is driven by rising colorectal cancer prevalence, increased screening awareness, advancements in non-invasive diagnostics (liquid biopsy, stool-based DNA tests), and emerging targeted therapies and immunotherapies. North America leads with 41% market share, while Asia-Pacific is the fastest-growing region.

The FDA approved VEPPANU (vepdegestrant), a first-of-its-kind PROTAC therapy developed by Pfizer and Arvinas for treating advanced breast cancer with ESR1 mutations. The Phase 3 VERITAC-2 trial showed vepdegestrant reduced disease progression risk by 43% compared to fulvestrant, with median PFS of 5 months versus 2.1 months. Guardant Health's Guardant360 CDx was also approved as a companion diagnostic for patient identification.

The global oncology biomarkers market is projected to grow from $17.3 billion in 2025 to $33.63 billion by 2030, with a CAGR of 14.3%. Growth is driven by rising cancer incidence, personalized oncology therapies, AI-driven biomarker discovery, liquid biopsy adoption, and early cancer detection focus. Key players include Roche, Novartis, and Thermo Fisher Scientific.

Praxis Precision Medicines (PRAX) has surged 685% over the past year, attracting an $80.5 million investment from Driehaus Capital Management. The clinical-stage biotech company recently submitted two FDA applications for therapies targeting essential tremor and rare developmental epilepsies. With $926 million in cash and potential revenue exceeding $20 billion if approved, the company is positioned for significant growth, though regulatory approval remains a key risk.

The FDA approved Guardant Health's Guardant360 CDx blood test as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer who may benefit from Pfizer's Braftovi treatment combined with cetuximab and chemotherapy. This marks the 25th companion diagnostic indication for the platform and expands non-invasive genomic testing access. Guardant Health stock surged 2.27% to $118.37, trading at a 52-week high with strong technical momentum.

The pan-genomic and multi-gene panel testing market is projected to grow from US$ 8.9 billion in 2024 to US$ 25.9 billion by 2032, driven by a 12.04% CAGR. Growth is fueled by rising clinical adoption of genomics-driven diagnostics, FDA approvals of comprehensive genomic profiling tests, advances in NGS technology and bioinformatics, and expanding implementation across oncology, rare diseases, and preventive medicine. North America leads the market while Asia-Pacific shows the fastest growth.

Eventide Asset Management sold 114,922 shares of Mirum Pharmaceuticals in Q3, but the position's value increased by approximately $50.70 million to $184.92 million due to the stock's 89% surge over the past year. The share reduction appears to be portfolio management rather than a loss of confidence, as Mirum posted strong Q3 revenue growth of 47% and raised full-year guidance, with the company now representing the fund's second-largest equity holding.

The Pre-Dx oncology market is entering a high-growth phase, driven by breakthrough non-invasive cancer detection technologies like liquid biopsy and multi-cancer early detection tests. The market is expected to generate substantial revenue growth, with North America leading and Asia Pacific showing the fastest growth potential.

The global oncology biomarker market is projected to grow from USD 34.16 billion in 2024 to USD 113.54 billion by 2034, with a 12.73% CAGR, driven by precision medicine, technological advances, and increasing cancer incidence.

The global breast cancer screening tests market is projected to grow from $4.75 billion in 2025 to $8.77 billion by 2034, with a 7.04% CAGR. Driven by increasing cancer awareness, technological advances in screening, and government initiatives, the market will see significant expansion in imaging and blood marker tests.

The global molecular diagnostics market is expected to grow from $23 billion in 2025 to $42.6 billion by 2030, driven by advances in genetic testing, cancer detection, and infectious disease diagnostics, with a 13.1% compound annual growth rate.