On Thursday, the U.S. Food and Drug Administration (FDA) approved Guardant Health Inc.’s (NASDAQ:GH) Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who may benefit from treatment with Braftovi (encorafenib) in combination with cetuximab and chemotherapy.The accelerated approval for Braftovi was supported by data from Pfizer Inc.’s (NYSE:PFE) Phase 3 BREAKWATER trial.DataThe study showed that treatment with encorafenib and cetuximab p ...

Core Insights - Guardant Health aims to provide individuals with more time free from disease, having pioneered the first liquid biopsy test for cancer therapy selection over 10 years ago [2] - The company has tested over 1 million patients and has received orders from over 12,000 oncologists and thousands of primary care physicians [2] - Guardant Health has invested approximately $2 billion in R&D to develop innovative products and establish itself as a leader in the liquid biopsy market [3] Company Overview - Guardant Health has expanded its offerings to include recurrence monitoring and cancer screening, demonstrating its commitment to helping more patients [2] - The company has built a world-class commercial organization, indicating strong operational capabilities and market presence [3] - Guardant Health believes it is still in the early stages of its growth and innovation journey [3]

Core Insights - Guardant Health reported a breakout year in 2025, with total revenue growth accelerating to 33% year-over-year, driven by innovation in its Smart Platform and strong commercial execution [2][5] - The company highlighted the success of its Shield product in the blood-based colorectal cancer screening market, with nearly 100,000 patients screened since FDA approval [2][5] - Guardant Health plans to launch multiple groundbreaking products in 2026 to sustain growth momentum in its Oncology business [2] Financial Performance - For Q4 2025, total revenue was approximately $280 million, an increase of 39% compared to Q4 2024 [5] - The company reported approximately 79,000 oncology tests in Q4 2025, a 38% increase year-over-year [5] - For the full year 2025, total revenue reached approximately $981 million, reflecting a 33% increase from 2024 [5] - The number of oncology tests conducted in 2025 was approximately 276,000, marking a 34% increase [5] - Shield screening tests totaled approximately 87,000 in 2025, up from 6,400 in the prior year [5] Cash Flow and Financial Position - Preliminary unaudited free cash flow was approximately negative $54 million for Q4 2025 and approximately negative $233 million for the full year 2025 [2] - As of December 31, 2025, the company had approximately $1.3 billion in cash, cash equivalents, restricted cash, and marketable debt securities [2]

Core Viewpoint - Inspira Technologies has announced a proposed two-part transaction involving the acquisition of a liquid biopsy diagnostics business and a concurrent $15 million strategic equity investment, aimed at expanding into the high-growth diagnostics market [1][2]. Equity Investment - The transaction includes a $15 million equity investment at a premium to the current market capitalization, based on a pre-money valuation of $180 million, reflecting the strategic investor's assessment of the liquid biopsy technology's value [3]. - The identity of the strategic investor will be disclosed after shareholder approval and execution of definitive agreements, with $12 million of the investment proceeds allocated to fund existing respiratory and blood monitoring technologies [4]. Strategic Acquisition - The acquisition involves an advanced liquid biopsy diagnostics business through an all-share transaction, allowing entry into the growing liquid biopsy market with a proprietary platform designed for cancer characterization [5]. - The platform has shown high concordance with traditional tissue biopsy in clinical validation studies, indicating its potential to provide meaningful diagnostic insights [5][6]. - The initial clinical focus of the platform is on breast cancer, with applicability across other oncology indications, and the global liquid biopsy market is projected to reach approximately $58 billion in the next decade [6]. Regulatory Pathway - Following the acquisition, the company plans to pursue FDA clearance for the liquid biopsy platform through the 510(k) regulatory pathway, leveraging existing reimbursement codes for intended clinical use [7]. Shareholder Protection Framework - The transaction includes a shareholder protection framework to preserve the economic upside of existing respiratory and blood-monitoring platforms for current shareholders while allowing participation in the growth potential of the liquid biopsy platform [9].

Deep Dive SAMPLE TECHNOLOGIES ADVANCING OUR LEADERSHIP IN SAMPLE PREPARATION November 21, 2025 #1 IN THE FIRST STEP OF EVERY MOLECULAR WORKFLOW Laboratory workflow Customers Academia / Research Applied testing Pharma Clinical Selected key applications(1) Biological sample Differentiated solutions for modular, integrated workflows Fast time to result, scalability and ease of use Platform-agnostic consumables PCR dPCR NGS Valuable molecular insights Sample technologies Critical first step in molecular workflo ...

Financial Data and Key Metrics Changes - Revenue for Q3 2025 grew 32% year-over-year, reaching $0.6 million [20] - Operating expenses decreased by 10% year-over-year, and net cash used in operating activities was down 33% compared to the prior year [20][21] - Net loss improved by 8% for the quarter and down 20% for the first three quarters compared to the prior year [20][21] Business Line Data and Key Metrics Changes - The company signed two significant agreements: one with Werfen for anti-phospholipid syndrome (APS) and another with Hologic for co-marketing the Nu.Q Discover service [4][8] - The Nu.Q NETs assay is being validated by Werfen for clinical utility in APS patients, with early results showing promise [5][6] - Hologic has already made its first sale of the Nu.Q Discover service, indicating strong initial traction [34] Market Data and Key Metrics Changes - The total addressable market (TAM) for APS is estimated at approximately $85 million annually, which is a strategic entry point for the company's NETs platform [8][27] - The combined TAM for cancer and sepsis diagnostics is approximately $25 billion annually, presenting substantial revenue opportunities [25] Company Strategy and Development Direction - The company aims to achieve cash neutrality by aligning income with expenditures through licensing agreements and milestone payments [21][24] - There is a focus on expanding the Nu.Q VET cancer test globally, with centralized lab automation being a key priority to accelerate revenue growth [22][23] - The company is actively pursuing additional licensing agreements in the human diagnostic space, mirroring its successful strategy in the veterinary market [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the partnerships with Werfen and Hologic, viewing them as transformative for future growth [34][36] - The company anticipates significant progress in clinical utility studies and expects to see more licensing deals in the near future [11][39] - Management acknowledged the challenges of the current market but emphasized the importance of delivering on commercialization plans [81][83] Other Important Information - The company is in discussions with around 10 leading diagnostic and liquid biopsy companies for potential partnerships [10] - The CAPTCHA-seq technology is expected to revolutionize liquid biopsy methods, with promising early results in cancer detection [12][16] Q&A Session Summary Question: Size of the anti-phospholipid syndrome market - The TAM for APS is estimated at $85-$90 million annually, which is a good starting point for the company's NETs platform [27][28] Question: Contribution of the Werfen partnership to Q3 revenue - The Werfen partnership has not yet contributed to revenue as they are still validating the assay on clinical samples [32] Question: Expectations for additional partnerships in 2026 - Management expects to close several additional partnerships in 2026, although the timing is uncertain [37][39] Question: Breakdown of product revenues - Product revenues are still lumpy, with significant contributions from both the Nu.Q VET tests and the Discover kits [45] Question: Conditions for milestone payments related to feline cancer testing - Milestone payments are contingent upon the publication of a paper, which is currently in progress [66][72]

Core Insights - Guardant Health's stock experienced a significant increase following a strong earnings report, showcasing a 40% volume growth in its oncology division [1][3] Financial Performance - The company reported total sales of $265.2 million, surpassing analyst expectations of $235.6 million, reflecting a 39% year-over-year growth [8] - Oncology sales rose by 31% to $184.4 million, exceeding the forecast of $174 million [5] - The company reported a loss of 74 cents per share, which was better than the anticipated loss of 79 cents [8] Product Performance - The volume of oncology tests shipped increased by 40% in the third quarter, following 30% growth in the second quarter and 25% in the first quarter [2][9] - Sales from the Shield blood test for colon cancer screening surged to $24 million from $1 million in the same quarter last year, significantly exceeding forecasts [6] Future Outlook - Guardant Health raised its full-year sales guidance to between $965 million and $970 million, an increase of $47.5 million from previous estimates, indicating a projected growth of 24% to 25% [12] - The company anticipates 25% growth in oncology sales and 30% growth in test volumes for the upcoming year [13]

Core Insights - BioMark Diagnostics has secured patents in China and Japan for its liquid biopsy technology aimed at early lung cancer detection, enhancing its intellectual property and commercial strategy in these key markets [1][2][3] Company Overview - BioMark Diagnostics Inc. specializes in developing liquid biopsy tests that utilize metabolomics and machine learning for early cancer detection, enabling earlier diagnosis and improved patient outcomes [4] Technology and Market Potential - The newly granted patents cover a platform that measures specific metabolite biomarkers, demonstrating a sensitivity of over 90% for early-stage lung cancer, which can lead to faster and more actionable clinical results [2][3] - The liquid biopsy market in China is projected to exceed US$670 million by 2030, while Japan's market is expected to surpass US$912 million, both showing robust double-digit growth driven by national screening policies and advanced diagnostics [3] Strategic Importance - Securing patents in China and Japan is seen as a transformational milestone for BioMark, positioning the company for significant commercial and clinical leadership, as well as opportunities for expansion, technology licensing, and strategic partnerships [3]

Core Insights - The article presents new data from a proof-of-concept study on the detection of circulating tumor cells (CTCs) in glioblastoma patients, highlighting the effectiveness of the Parsortix label-free methodology [1] Company Overview - ANGLE plc is a leading company in the liquid biopsy sector, specializing in innovative CTC solutions for research, drug development, and clinical oncology [1] Study Details - The study involved 15 newly diagnosed, treatment-naïve glioblastoma (GBM) patients, with blood samples processed using the Parsortix® system and CellKeep™ slides [1]

S-1 1 bion_s1.htm FORM S-1 As filed with the Securities and Exchange Commission on February 14, 2023 Registration No. 333-[●] UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIONEXUS GENE LAB CORP. Wyoming 8071 35-2604830 (I.R.S. Employer (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Identification Number) Unit 02, Level 10, Tower B, Vertical Busi ...