LabCorp

FDA approves Caris Life Sciences' MI Cancer Seek as companion diagnostic for multiple cancer drugs across six cancer types, including solid tumors, breast cancer, colorectal cancer, melanoma, non-small cell lung cancer, and endometrial carcinoma. The assay uses whole exome and transcriptome sequencing to identify patients likely to benefit from specific therapies, such as Keytruda, Erbitux, Piqray, and Lenvima.

The global Biotechnology and Pharmaceutical Services Outsourcing market size is expected to grow from USD 48.25 billion in 2024 to USD 83.28 billion by 2034, with a CAGR of 5.61%. Key segments include consulting services (24% share in 2024), regulatory affairs (highest CAGR of 8.37%), and pharmaceutical companies (60% share in 2024). North America dominates the market, driven by strong CMOs and CROs presence, while Asia Pacific is expected to grow fastest due to increasing investments and reforms.

The clinical trials market is projected to grow from USD 52.39 billion in 2023 to USD 102.12 billion by 2031, at a CAGR of 8.7%. This growth is driven by the demand for novel therapies, technological advancements, and an aging population. Key trends include decentralized trials, patient-centric approaches, adaptive designs, and AI integration, which enhance trial efficiency and patient experience.

Labs face operational changes to comply with FDA's expanded oversight of lab developed tests (LDTs), which now require medical device standards. Health industry groups warn of added costs and administrative burdens, potentially reducing patient access to innovative tests. Lab organizations are challenging the rule in court, arguing it duplicates existing CLIA regulations. The FDA maintains its rule complements CLIA, focusing on test design and development. Labs are preparing for compliance, despite uncertainties, and await further FDA guidance.

The Medical Research Study Management Market report forecasts growth insights and market size by 2031, profiling key players like Medidata Solutions, Inc., Oracle Corporation, and Veeva Systems. It segments the market by types and applications, and analyzes regional trends, competitive landscape, and market drivers.

The FDA approved Exact Sciences’ Cologuard Plus colorectal cancer test, an updated version with higher specificity than its predecessor, expected to launch in 2025 with Medicare coverage. Despite initial setbacks in securing a Medicare price premium, analysts anticipate future success in obtaining a higher price, which could improve Exact Sciences’ margins and help maintain market share against new competitors.

FDA updates PEMGARDA Fact Sheet, removing contested statement on KP.3.1.1's reduced susceptibility to pemivibart. New data shows neutralization potency in line with prior variants, including KP.3.1.1 and LB.1.

GeneDx, rebranded from Sema4 in 2023, has seen a 3,600% stock surge due to a successful pivot to whole exome and genome sequencing, focusing on rare disease diagnosis in children. The company projects $255-265 million in revenue for 2024 and aims for profitability in 2025, supported by a $3 billion market for rare disease testing expected to grow rapidly.

Virtual Clinical Trials Market expected to grow from USD 2.64B in 2023 to USD 7.11B by 2029 at a CAGR of 17.95%, driven by advancements in digitalization and IoT adoption in health facilities. Key vendors include Dassault Systemes, Medable, Science 37, THREAD, Castor, Clinical Ink, IQVIA, and Icon.

Onconetix, Inc. announced stockholder approval of all proposals at the 2024 Annual Meeting, including the election of Timothy Ramdeen and Ajit Singh as Class III directors, amendments to the 2022 Equity Incentive Plan, and a 1-for-40 reverse stock split effective September 24, 2024, aimed at regaining compliance with Nasdaq's minimum bid price requirement.