Table of Contents As filed with the Securities and Exchange Commission on October 17, 2025. Registration Statement No. 333-290761 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO.1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BILLIONTOONE, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 8071 81-1082020 (Primary Standard Industrial Classification Code Number) 1035 O'B ...

Core Insights - Co-Diagnostics, Inc. will participate in the 2025 Maxim Growth Summit on October 22-23 at The Hard Rock Hotel NYC [1] - The summit will feature industry leaders and discussions on various sectors including biotechnology, artificial intelligence, and energy [2] - Co-Diagnostics will engage in one-on-one meetings with institutional investors and senior analysts during the event [3] Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company based in Utah, specializing in the development of advanced diagnostic technologies [5] - The company's proprietary technology is designed for tests that detect and analyze nucleic acid molecules (DNA or RNA) [5] - Co-Diagnostics is also working on specific tests for its Co-Dx PCR at-home and point-of-care platform, which is currently under regulatory review [5]

Core Viewpoint - BillionToOne has filed for an initial public offering (IPO) in the United States, indicating its intention to raise capital through public markets [1] Company Summary - BillionToOne is preparing to enter the public market by filing for an IPO, which suggests a strategic move to enhance its financial position and expand its operations [1]

Table of Contents As filed with the Securities and Exchange Commission on October 7, 2025. Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BILLIONTOONE, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 8071 81-1082020 (Primary Standard Industrial Classification Code Number) 1035 O'Brien Drive Menlo Park, CA ...

Core Insights - Qiagen N.V. is recognized as one of the most oversold healthcare stocks in 2025, focusing on expanding its precision medicine capabilities through innovative testing solutions [1] Financial Performance - In Q2 2025, Qiagen reported a 7% year-over-year growth in net sales, driven by strong adoption of key products like QIAstat-Dx and QuantiFERON [2] - The company plans to launch three new instruments in late 2025 to enhance diagnostic capabilities and support future growth [2] Product Innovations - Qiagen has advanced its precision oncology portfolio with new QIAseq panels that enable fast and comprehensive cancer genomic profiling, improving cost-effectiveness for laboratories [3] - Innovations also include QIAseqHYB Read Panels for long-read sequencing, addressing complex genomic regions and supporting various next-generation sequencing platforms [3] Strategic Developments - A significant milestone for Qiagen in 2025 is the FDA clearance and commercial rollout of QIAstat-Dx Rise, which is expected to enhance diagnostic access and testing capacity in the U.S. healthcare market [4] - These developments align with Qiagen's strategy to strengthen its molecular diagnostics offerings and expand its role in precision medicine and biotherapeutic development [4]

Company Overview - Qiagen N.V. is a global leader in molecular diagnostics and sample preparation technologies, headquartered in the Netherlands and operating in over 30 countries under CEO Thierry Bernard [2] - The company offers a wide range of solutions including nucleic acid extraction systems, PCR reagents, digital PCR platforms, next-generation sequencing kits, and proteomics tools [2] Financial Performance - In Q2 2025, Qiagen reported net sales of $534 million, representing a 7% increase from the previous year [3] - The adjusted operating income margin was 29.9%, an increase of 1.5 percentage points [3] - Growth was driven by strong demand for products such as QIAstat-Dx, which grew 41% on a constant exchange rate (CER), and QuantiFERON, which increased 11% CER [3] - The company raised its full-year 2025 net sales growth outlook to 4–5% CER and reaffirmed its adjusted diluted EPS targets [3] Product Innovation - Qiagen launched QIAseq xHYB Long Read Panels to enhance target enrichment for long-read sequencing platforms, allowing for more detailed analysis of complex genomic regions [4] - The company is expanding its digital and automation offerings, with growth in QIAcuity digital PCR systems and the QIAGEN Digital Insights software platform [4] - Qiagen is preparing to launch three new instruments by late 2025 to strengthen its molecular diagnostics capabilities [4]

Summary of Insight Molecular Diagnostics FY Conference Company Overview - **Company**: Insight Molecular Diagnostics - **Industry**: Healthcare, specifically diagnostics Core Points and Arguments 1. **Market Opportunity in Transplant Diagnostics**: The U.S. transplant monitoring market is valued at approximately $2 billion, identified as underpenetrated and inefficient, presenting a significant opportunity for disruption [3][4] 2. **Focus on Point of Care**: The company aims to bring testing closer to patients, enhancing care and capturing market share by simplifying workflows and enabling transplant centers to retain revenue [2][4] 3. **Regulatory and Reimbursement Strategy**: The company has a well-defined path to regulatory approval, with expectations to submit to the FDA by the end of the year, and has established reimbursement rates, notably $2,753 from Multi-X [5][8] 4. **High-Value Recurring Revenue**: The diagnostics space offers high margins, with tests costing tens of dollars to manufacture but charging hundreds, leading to a projected $1 billion global opportunity in regulated transplant testing [6][7] 5. **Partnerships and Collaborations**: The company has partnered with three of the top 10 transplant centers in the U.S. and has a strategic relationship with Bio-Rad Laboratories, which has made multiple equity investments [7][8] 6. **Clinical Validation and Data**: The company has published extensively in transplant diagnostics and has shown improved positive predictive value from 50% to 80%, enhancing the reliability of their tests [10][9] 7. **Registry for Data Collection**: A registry is being established to gather data on advanced monitoring technologies, which will support the case for improved patient outcomes and assist in payer negotiations [10][25] Additional Important Content 1. **Physician Adoption Challenges**: Physicians are cautious about adopting new technologies, requiring head-to-head comparisons with existing tests to ensure equivalency [23][24] 2. **Payer Dynamics**: While CMS recognizes the technology's utility, private payers are more hesitant, necessitating further data collection to demonstrate improved outcomes [25] 3. **Future Investment Plans**: The company plans to focus on incremental investments in transplant diagnostics before potentially expanding into heart and lung diagnostics as cash flow improves [16][20] This summary encapsulates the key insights from the conference, highlighting the strategic direction, market opportunities, and challenges faced by Insight Molecular Diagnostics in the healthcare diagnostics industry.

Group 1 - The core consideration for companies in molecular diagnostics is their ability to translate complex scientific concepts into commercially viable businesses [1] - Nabeel Bukhari combines legal expertise in corporate law with self-taught financial analysis skills, providing a unique perspective on business dynamics [2] - His insights have been published in respected platforms and featured in well-known publications, enhancing the understanding of financial analysis in the context of corporate law [2] Group 2 - There is no indication of any stock or derivative positions held by the analyst in the companies mentioned, ensuring an unbiased perspective [3] - The article expresses personal opinions and does not involve compensation from any company mentioned, reinforcing the independence of the analysis [3] - Seeking Alpha clarifies that past performance does not guarantee future results and that the views expressed may not reflect the platform's overall stance [4]

Investment Summary - iMDx employs a disruptive approach to molecular diagnostic testing by empowering local labs with kits, contrasting the central lab model[19] - The company has secured a go-to-market strategic partner and equity investment[19] - iMDx possesses a full R&D pipeline to fuel portfolio expansion over the next decade[19] - The company's IP portfolio is attractive to partners and enables value protection[19] Transplant Market - Kidney transplant patients face approximately a 202% (1 in 5) chance of their body rejecting the donor kidney[47] - The US market supports a $500 million annual revenue potential for transplant testing, currently generated by competitors[84] - The global transplant testing market is estimated at $1 billion today, with potential to expand to approximately $2 billion with claims expansion[86] - Medicare reimbursement for iMDx's transplant test was boosted to $2,753 per result in May 2025[80] Oncology Market - The estimated total addressable market (TAM) for oncology therapy selection in the US is $2 billion[104] - The estimated total addressable market (TAM) for oncology copy number instability (CNI) monitoring in the US is $4 billion[109]

Core Viewpoint - Exact Sciences (EXAS) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, suggesting that an upward revision in earnings estimates can lead to increased buying pressure and higher stock prices [4][5]. - The Zacks Consensus Estimate for Exact Sciences has increased by 255.6% over the past three months, reflecting a strong positive trend in earnings outlook [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Only the top 5% of Zacks-covered stocks receive a "Strong Buy" rating, indicating superior earnings estimate revisions, which positions Exact Sciences favorably for potential market-beating returns [9][10].