Daniel Brennan

Mark Massaro

Puneet Souda

Tycho Peterson

Kyle Mikson

Subhalaxmi Nambi

William Bonello

Daniel Arias

Eve Burstein

Patrick Donnelly

Rachel Vatnsdal Olson

Tejas Savant

Bill Bonello

Dan Arias

Daniel Leonard

Douglas Schenkel

Luke Sergott

Mason Carrico

Matthew Sykes

Rachel Vatnsdal

Salem Salem

Subbu Nambi

Yuko Oku

- **GATC Health** launched **Derisq**, an AI Report for Predictive Risk Intelligence, at Fierce Biotech Week on **October 7, 2025**.  **[1576280_d372687ccb7444baa0db2371613fc2bc_0]** 
- Derisq provides validated, actionable insights on drug safety, efficacy, and off-target risks, empowering biotech leaders and investors to make informed decisions before committing to clinical trials.  **[1576280_d372687ccb7444baa0db2371613fc2bc_0]** 
- The University of California, Irvine confirmed Derisq’s predictive accuracy, with **91% specificity** for off-target risks and **86% sensitivity** for target activation prediction.  **[1576280_d372687ccb7444baa0db2371613fc2bc_0]** **[1576280_d372687ccb7444baa0db2371613fc2bc_1]** 
- The technology is trusted by **Lloyd’s of London** for clinical trial insurance and utilized by leading biopharma companies, insurance underwriters, and investors.  **[1576280_d372687ccb7444baa0db2371613fc2bc_0]** **[1576280_d372687ccb7444baa0db2371613fc2bc_1]**

GATC Health Announces Derisq Launch at Fierce Biotech Week 2025

- The **U.S. Food and Drug Administration (FDA) has approved Guardant360 CDx** as a companion diagnostic for Eli Lilly and Company’s Inluriyo (imlunestrant).  **[1576280_cdce5cbc6af84326bfd8a14dbb4858cf_0]** 
- This approval identifies advanced breast cancer patients with **ESR1 mutations**, which are present in **40% of HR+, HER2- advanced breast cancers**.  **[1576280_cdce5cbc6af84326bfd8a14dbb4858cf_0]** 
- This marks the **second FDA-approved indication** for Guardant360 CDx in breast cancer treatment and its **sixth overall CDx claim** approved by the FDA.  **[1576280_cdce5cbc6af84326bfd8a14dbb4858cf_0]** 
- Guardant360 CDx is now the **only FDA-approved companion diagnostic** for targeted therapy in advanced breast cancer patients with ESR1 mutations.  **[1576280_cdce5cbc6af84326bfd8a14dbb4858cf_0]**

Guardant Health's Guardant360 CDx Receives FDA Approval as Companion Diagnostic for Eli Lilly's Inluriyo

- Guardant Health projects **total revenue** for 2025 to be between **$915 million and $925 million**, representing **24% to 25%** year-over-year growth.  **[1576280_2156086_38]**  The company has also increased its 2028 revenue target to **$2.2 billion**, up from a previous target of $2 billion, expecting a compound annual growth rate (CAGR) of approximately **34%** between 2025 and 2028.  **[1576280_2156086_38]** **[1576280_2156086_42]** 
- The company is accelerating its timeline to achieve company-wide free cash flow breakeven by **12 months**, now targeting **Q4 2027**.  **[1576280_2156086_41]** **[1576280_2156086_42]**  The oncology business (excluding screening) is on track to reach cash flow breakeven by the end of 2025.  **[1576280_2156086_41]** 
- Guardant Health announced the expansion of its **Shield** product offering to include **multi-cancer detection results**, which will be available nationally in October.  **[1576280_2156086_1]** **[1576280_2156086_42]**  The company also launched Guardant Reveal for therapy monitoring in Q4 2025 and submitted Guardant360 Liquid PMA to the FDA.  **[1576280_2156086_42]** 
- Significant average selling price (ASP) improvements are noted across products, with Shield's ADLT status at **$1,495** and its 2028 ASP target increased to approximately **$700**.  **[1576280_2156086_39]**  Guardant Reveal's ASP reached **$600-$700** in Q2 2025, with a target of **$1,000** by 2028.  **[1576280_2156086_21]**

Guardant Health Updates 2025 Revenue Guidance and Accelerates Profitability Timeline

Guardant Health (GH)