Latest news with #FoundationMedicine
Business Wire
23-05-2025
- Business
- Business Wire
Foundation Medicine Expands Immunohistochemistry (IHC) Testing Portfolio to Include MET IHC Testing
BOSTON--(BUSINESS WIRE)-- Foundation Medicine, Inc., a genomics company committed to transforming cancer care, today announced that it has expanded its immunohistochemistry (IHC) test offerings to include MET IHC testing using the VENTANA® MET (SP44) RxDx assay, now available as an add-on to comprehensive genomic profiling (CGP) test orders for patients with non-squamous non-small cell lung cancer (NSCLC). Using antibodies to detect specific proteins in tissue samples, Foundation Medicine's IHC test offerings complement its CGP tests and together support healthcare providers to make well-informed treatment decisions for their patients. Foundation Medicine's new MET (c-Met) IHC offering helps healthcare providers identify patients eligible for a first-in-class MET-directed antibody drug conjugate (ADC) for NSCLC patients with c-Met protein overexpression. With c-Met overexpression present in approximately 25% of NSCLC cases, 1 this newly approved treatment offers a promising option for eligible patients. Foundation Medicine's IHC test offerings include: MET IHC testing, which helps identify patients with locally advanced or metastatic non-squamous NSCLC who exhibit high c-Met protein overexpression and may be eligible for a new targeted treatment. 2 CLDN18 (Claudin 18) IHC testing, which helps identify patients with gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2-positive, potentially qualifying them for a targeted treatment. 3 HER2 IHC testing, which helps identify patients with advanced HER2-positive solid tumors who may be eligible for a targeted treatment. 4 FOLR1 IHC testing, which helps identify patients with ovarian, fallopian tube, or primary peritoneal cancer whose tumors are folate receptor alpha-positive and who may be eligible for a targeted treatment. 5 Four PD-L1 IHC (22C3, 28-8, SP142, SP263) tests, which help identify patients who may benefit from immunotherapies; PD-L1 IHC testing has become a crucial tool for personalizing treatment strategies across various cancers, including NSCLC, triple negative breast cancer, cervical cancer, HER2-positive gastric/gastroesophageal junction adenocarcinoma, head and neck squamous cell carcinoma, and esophageal squamous cell carcinoma. 6 'IHC testing complements our high-quality biomarker tests, offering healthcare providers a streamlined, one-stop solution that empowers them to more accurately predict potential treatment selection and ensure patients receive the medicines most likely to work for them,' says Foundation Medicine's Chief Commercial Officer Annie Murphy. 'We are excited to expand our IHC offerings, including the newly introduced MET IHC test, which supports treatment decisions for certain patients with non-squamous NSCLC, a group that has historically faced limited treatment options and poor prognosis.' Foundation Medicine plans to continue expansion of its IHC test offerings and is committed to launching new IHC tests rapidly following FDA approval of companion diagnostic kits to minimize delays in patient treatment. About Foundation Medicine Foundation Medicine is a genomics company dedicated to transforming cancer care. We develop high-quality diagnostic tests that accurately identify the genomic mutations driving a patient's cancer, match a patient to the most effective treatment options, including targeted therapies, immunotherapies, or clinical trials, and monitor a patient's response to treatment. For more information, please visit us on and follow us on LinkedIn, Instagram, X and YouTube. Foundation Medicine® is a registered trademark of Foundation Medicine, Inc.
Business Wire
22-05-2025
- Business
- Business Wire
Foundation Medicine to Present Over 15 Abstracts at the 2025 ASCO ® Annual Meeting
BOSTON--(BUSINESS WIRE)-- Foundation Medicine, Inc., a genomic company committed to transforming cancer care, today announced that the company and its collaborators will present more than 15 abstracts demonstrating the value of high-quality biomarker tests to inform cancer care at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting from May 30 to June 3 in Chicago. Foundation Medicine's research presented at the meeting will include new insights across breast cancer, lung cancer and prostate cancer, including an oral presentation highlighting the findings from the COMRADE phase 2 clinical trial in castration resistant prostate cancer, which leveraged the research use version of FoundationOne®Monitor, the company's tissue-free treatment response monitoring assay, for serial ctDNA analysis. (Abstract 5007, Tuesday, June 3, at 11:57 am – 12:09 pm CT, Hall D1) 'In partnership with over 30 clinical collaborators, Foundation Medicine's new research at the ASCO Annual Meeting further reinforces the important role high-quality biomarker testing plays in delivering personalized cancer care,' said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. 'From exploring the role of innovative and complex biomarkers to expanding the clinical utility of genomic profiling, we are excited to demonstrate how our testing portfolio, including our new treatment response monitoring assay, can help providers make more informed treatment decisions for their patients.' To access the abstracts being presented at the 2025 ASCO Annual Meeting, please visit Follow Foundation Medicine on LinkedIn, X and Instagram for more updates from #ASCO25 and visit us in person at booth #27021. Complete list of Foundation Medicine's abstracts at the 2025 ASCO Annual Meeting Abstract Number Title Product 3570 Comparison of MET genomic alterations (GA) identified in colorectal cancer (CRC) vs gastric cancer (GCA) FoundationOne®CDx 4153 Pancreatic adenosquamous carcinoma (PASC): A comparative genomic landscape study FoundationOne®CDx 4183 BRCA1/2 and PALB2 short variants (SVs) contributed by clonal hematopoiesis (CH) in liquid biopsies (LBx) from patients with advanced pancreatic cancer (PC) FoundationOne®CDx / FoundationOne®Liquid CDx 8036 Tumor type prediction via tissue- and liquid-based comprehensive genomic profiling: High-specificity tobacco signature detection to support lung cancer diagnosis FoundationOne®CDx / FoundationOne®Liquid CDx 8039 Clinical utility of pathologist-directed comprehensive comparative molecular profiling for the classification of separate primary lung cancers vs. intrapulmonary metastasis FoundationOne®CDx 8628 Association of circulating tumor DNA (ctDNA) variant allelic frequency (VAF) with outcomes on matched targeted therapies (TT) in advanced non-small cell lung cancer (aNSCLC) FoundationOne®Liquid CDx 11161 Real-world analysis of factors influencing turnaround time (TAT) for tissue comprehensive genomic profiling (CGP) in non-small cell lung cancer (NSCLC) FoundationOne®CDx Sunday, June 1 5592 Distinguishing tumor vs. clonal hematopoiesis (CH)–derived TP53 and BRCA1/2 alterations in ovarian cancer liquid biopsies with a predictive algorithm to inform clinical decision-making FoundationOne®CDx / FoundationOne®Liquid CDx 6528 Nucleophosmin (NPM1) genomic alterations (GA) in acute myeloid leukemia (AML): A genomic landscape study FoundationOne®Heme 9520 Homologous recombination deficiency signature (HRDsig) in advanced cutaneous melanoma (ACM): A genomic landscape study FoundationOne®CDx Monday, June 2 1043 TP53 genomic alterations including targetable TP53 Y220C mutation in clinically advanced breast cancer FoundationOne®CDx 1048 Genomic alterations (GAs) associated with durability of benefit from trastuzumab deruxtecan (T-DXd), trastuzumab emtansine (T-DM1) and sacituzumab govitecan (SG) in metastatic breast cancer (MBC) FoundationOne®CDx / FoundationOne®Liquid CDx 1065 Quantifying the clinical impact of tissue reflex testing for liquid biopsy ESR1 mutation-negative cases with low ctDNA tumor fraction (TF) in HR(+)HER2(-) breast cancer FoundationOne®CDx / FoundationOne®Liquid CDx 3081 Genomic landscape of 5'methylthioadenosine phosphorylase (MTAP) deleted (MTAP loss) non-squamous carcinoma of unknown primary site (nsCUP) FoundationOne®CDx 5064 Additive clinical utility of tissue biomarkers of microsatellite instability (MSI) status and tumor mutational burden (TMB) to predict immune checkpoint inhibitor (ICI) effectiveness for real-world patients with metastatic castration-resistant prostate cancer (mCRPC) FoundationOne®CDx 4564 Fibroblast growth factor receptor 3 (FGFR3) alteration status and outcomes with immune checkpoint inhibitors (ICPI) in patients with metastatic urothelial carcinoma FoundationOne®CDx Tuesday, June 3 5007 A multicenter, randomized, phase 2, investigator-initiated ETCTN trial of olaparib + radium-223 vs. radium-223 in men with castration-resistant prostate cancer (CRPC) with bone metastases (BM) (COMRADE): Initial efficacy and biomarker analysis Expand About Foundation Medicine Foundation Medicine is a genomics company dedicated to transforming cancer care. We develop high-quality diagnostic tests that accurately identify the genomic mutations driving a patient's cancer, match a patient to the most effective treatment options, including targeted therapies, immunotherapies or clinical trials, and monitor a patient's response to treatment. For more information, please visit us on and follow us on LinkedIn, Instagram, X and YouTube. About FoundationOne®CDx FoundationOne®CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit About FoundationOne®Liquid CDx FoundationOne®Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit About FoundationOne®Heme FoundationOne®Heme is a laboratory developed test that was developed and its performance characteristics determined by Foundation Medicine. FoundationOne Heme has not been cleared or approved by the U.S. Food and Drug Administration. For more information on FoundationOne Heme, please see its Technical Specifications at The test employs RNA sequencing in addition to DNA sequencing to simultaneously detect all classes of genomic alterations, including base pair substitutions, insertions and deletions, copy number alterations and rearrangements, and gene fusions. *For Research Use Only. Not for use in diagnostic procedures.
Yahoo
22-05-2025
- Business
- Yahoo
Foundation Medicine to Present Over 15 Abstracts at the 2025 ASCO® Annual Meeting
BOSTON, May 22, 2025--(BUSINESS WIRE)--Foundation Medicine, Inc., a genomic company committed to transforming cancer care, today announced that the company and its collaborators will present more than 15 abstracts demonstrating the value of high-quality biomarker tests to inform cancer care at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting from May 30 to June 3 in Chicago. Foundation Medicine's research presented at the meeting will include new insights across breast cancer, lung cancer and prostate cancer, including an oral presentation highlighting the findings from the COMRADE phase 2 clinical trial in castration resistant prostate cancer, which leveraged the research use version of FoundationOne®Monitor, the company's tissue-free treatment response monitoring assay, for serial ctDNA analysis. (Abstract 5007, Tuesday, June 3, at 11:57 am – 12:09 pm CT, Hall D1) "In partnership with over 30 clinical collaborators, Foundation Medicine's new research at the ASCO Annual Meeting further reinforces the important role high-quality biomarker testing plays in delivering personalized cancer care," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "From exploring the role of innovative and complex biomarkers to expanding the clinical utility of genomic profiling, we are excited to demonstrate how our testing portfolio, including our new treatment response monitoring assay, can help providers make more informed treatment decisions for their patients." To access the abstracts being presented at the 2025 ASCO Annual Meeting, please visit Follow Foundation Medicine on LinkedIn, X and Instagram for more updates from #ASCO25 and visit us in person at booth #27021. Complete list of Foundation Medicine's abstracts at the 2025 ASCO Annual Meeting Abstract Number Title Product Saturday, May 31 3570 Comparison of MET genomic alterations (GA) identified in colorectal cancer (CRC) vs gastric cancer (GCA) FoundationOne®CDx 4153 Pancreatic adenosquamous carcinoma (PASC): A comparative genomic landscape study FoundationOne®CDx 4183 BRCA1/2 and PALB2 short variants (SVs) contributed by clonal hematopoiesis (CH) in liquid biopsies (LBx) from patients with advanced pancreatic cancer (PC) FoundationOne®CDx / FoundationOne®Liquid CDx 8036 Tumor type prediction via tissue- and liquid-based comprehensive genomic profiling: High-specificity tobacco signature detection to support lung cancer diagnosis FoundationOne®CDx / FoundationOne®Liquid CDx 8039 Clinical utility of pathologist-directed comprehensive comparative molecular profiling for the classification of separate primary lung cancers vs. intrapulmonary metastasis FoundationOne®CDx 8628 Association of circulating tumor DNA (ctDNA) variant allelic frequency (VAF) with outcomes on matched targeted therapies (TT) in advanced non-small cell lung cancer (aNSCLC) FoundationOne®Liquid CDx 11161 Real-world analysis of factors influencing turnaround time (TAT) for tissue comprehensive genomic profiling (CGP) in non-small cell lung cancer (NSCLC) FoundationOne®CDx Sunday, June 1 5592 Distinguishing tumor vs. clonal hematopoiesis (CH)–derived TP53 and BRCA1/2 alterations in ovarian cancer liquid biopsies with a predictive algorithm to inform clinical decision-making FoundationOne®CDx / FoundationOne®Liquid CDx 6528 Nucleophosmin (NPM1) genomic alterations (GA) in acute myeloid leukemia (AML): A genomic landscape study FoundationOne®Heme 9520 Homologous recombination deficiency signature (HRDsig) in advanced cutaneous melanoma (ACM): A genomic landscape study FoundationOne®CDx Monday, June 2 1043 TP53 genomic alterations including targetable TP53 Y220C mutation in clinically advanced breast cancer FoundationOne®CDx 1048 Genomic alterations (GAs) associated with durability of benefit from trastuzumab deruxtecan (T-DXd), trastuzumab emtansine (T-DM1) and sacituzumab govitecan (SG) in metastatic breast cancer (MBC) FoundationOne®CDx / FoundationOne®Liquid CDx 1065 Quantifying the clinical impact of tissue reflex testing for liquid biopsy ESR1 mutation-negative cases with low ctDNA tumor fraction (TF) in HR(+)HER2(-) breast cancer FoundationOne®CDx / FoundationOne®Liquid CDx 3081 Genomic landscape of 5'methylthioadenosine phosphorylase (MTAP) deleted (MTAP loss) non-squamous carcinoma of unknown primary site (nsCUP) FoundationOne®CDx 5064 Additive clinical utility of tissue biomarkers of microsatellite instability (MSI) status and tumor mutational burden (TMB) to predict immune checkpoint inhibitor (ICI) effectiveness for real-world patients with metastatic castration-resistant prostate cancer (mCRPC) FoundationOne®CDx 4564 Fibroblast growth factor receptor 3 (FGFR3) alteration status and outcomes with immune checkpoint inhibitors (ICPI) in patients with metastatic urothelial carcinoma FoundationOne®CDx Tuesday, June 3 5007 A multicenter, randomized, phase 2, investigator-initiated ETCTN trial of olaparib + radium-223 vs. radium-223 in men with castration-resistant prostate cancer (CRPC) with bone metastases (BM) (COMRADE): Initial efficacy and biomarker analysis Research use version of FoundationOne®Monitor* About Foundation MedicineFoundation Medicine is a genomics company dedicated to transforming cancer care. We develop high-quality diagnostic tests that accurately identify the genomic mutations driving a patient's cancer, match a patient to the most effective treatment options, including targeted therapies, immunotherapies or clinical trials, and monitor a patient's response to treatment. For more information, please visit us on and follow us on LinkedIn, Instagram, X and YouTube. About FoundationOne®CDxFoundationOne®CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit About FoundationOne®Liquid CDxFoundationOne®Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit About FoundationOne®Heme FoundationOne®Heme is a laboratory developed test that was developed and its performance characteristics determined by Foundation Medicine. FoundationOne Heme has not been cleared or approved by the U.S. Food and Drug Administration. For more information on FoundationOne Heme, please see its Technical Specifications at test employs RNA sequencing in addition to DNA sequencing to simultaneously detect all classes of genomic alterations, including base pair substitutions, insertions and deletions, copy number alterations and rearrangements, and gene fusions. *For Research Use Only. Not for use in diagnostic procedures. View source version on Contacts Media: Danielle Johns, 845-304-7408newsroom@ Sign in to access your portfolio
Globe and Mail
14-05-2025
- Health
- Globe and Mail
Hot Flashes in Prostate Cancer Market Expected to Strengthen Through 2032 with Growing Awareness and Novel Interventions
The hot flashes in prostate cancer market is poised for significant growth through 2032, driven by increasing awareness, improved diagnosis, and the development of more effective interventions from companies such as, Foundation Medicine, Bayer, Ipsen, Exelixis, AstraZeneca, and Synact Pharma, among others, addressing this debilitating side effect of androgen deprivation therapy (ADT). DelveInsight's " Hot Flashes in Prostate Cancer Market Insights, Epidemiology and Market Forecast-2032" report provides an in-depth understanding of hot flashes in prostate cancer patients, historical and forecasted epidemiology trends, as well as market dynamics across the 7MM, which include, the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. The report covers current treatment practices, emerging therapies, market share of individual treatments, and hot flashes in the prostate cancer market size, offering valuable insights for healthcare stakeholders and pharmaceutical developers. The US currently represents the largest share of the hot flashes in the prostate cancer market, with substantial growth projected through 2032. This growth trajectory is supported by favorable reimbursement policies, increased awareness among healthcare providers, and the rapid adoption of novel interventions targeting this specific symptom. The EU4 countries and the United Kingdom collectively constitute the second-largest market segment, while Japan shows promising growth potential as awareness of this condition increases in the Asia-Pacific region. Download the Hot Flashes in Prostate Cancer Market Forecast Report to understand which factors are driving the Hot Flashes in Prostate Cancer market @ Hot Flashes in Prostate Cancer Market Trends. Hot flashes, commonly associated with menopause in women, have emerged as a significant phenomenon in men undergoing prostate cancer treatment, particularly those receiving androgen deprivation therapy. ADT works by reducing testosterone levels, which often triggers sudden and intense waves of heat accompanied by perspiration and flushed skin. This treatment-induced side effect affects a substantial proportion of prostate cancer patients, with the prevalence expected to increase as ADT remains a cornerstone therapy for hormone-sensitive prostate cancer management. Traditionally seen as a female experience, these vasomotor symptoms now represent a significant unmet need in male oncology care, affecting treatment adherence and quality of life. DelveInsight's analysis shows that between 30% and 80% of men with prostate cancer, especially those undergoing androgen deprivation therapy (ADT), experience hot flashes. The onset of hot flashes typically occurs within weeks of starting hormone therapy, and the symptoms can persist for months or even years. Furthermore, the prevalence is higher in older men, with a mean age of onset around 70, and the median number of hot flashes reported is about three per day. While most men eventually experience remission of symptoms, a significant proportion continue to have hot flashes long-term, which can negatively affect quality of life. Discover evolving trends in the Hot Flashes in Prostate Cancer patient pool forecasts @ Hot Flashes in Prostate Cancer Epidemiological Analysis. The current landscape of hot flash management in prostate cancer encompasses various approaches, including pharmacological interventions such as hormone replacement therapies, antidepressants, anticonvulsants, and non-pharmacological strategies, including lifestyle modifications and wearable cooling technologies. The market has witnessed an increased focus on addressing this side effect, prompting innovative research into targeted therapies that specifically address the neurohormonal pathways involved in hot flash generation without compromising the efficacy of anticancer treatments. This represents a significant shift from historical approaches that often considered hot flashes an inevitable and acceptable consequence of life-extending prostate cancer therapies. Recent developments have significantly shaped the evolving landscape of hot flashes management in prostate cancer. Several effective treatments, such as Oxybutynin, an oral medication traditionally used for overactive bladder, have shown strong results in reducing both the frequency and severity of hot flashes in men on ADT, as demonstrated in a 2024 phase II trial. Non-hormonal agents like venlafaxine have also shown efficacy in smaller studies. New hormone therapies, such as ORGOVYX (relugolix), the first oral GnRH antagonist approved by the FDA, offer convenient alternatives to injectable treatments and may help manage hot flashes as part of overall ADT regimens. Additionally, a ready-to-use 3-month leuprolide depot formulation is nearing FDA approval, promising more flexible treatment options for advanced prostate cancer. Research is ongoing into novel agents targeting the neurokinin pathway, such as fezolinetant and elinzanetant, which have shown promise in reducing hot flashes in cancer patients, although data in prostate cancer specifically are still emerging. Discover evolving trends in the Hot Flashes in Prostate Cancer treatment landscape @ Hot Flashes in Prostate Cancer Recent Developments. Looking ahead, the hot flashes in prostate cancer market is expected to witness substantial growth driven by several factors, including the rising incidence of prostate cancer, increased adoption of ADT as a standard treatment approach, growing awareness among healthcare providers about the impact of hot flashes on treatment adherence and patient quality of life, and the development of novel targeted interventions. Companies such as Foundation Medicine, Bayer (ETR: BAYN), Ipsen (EPA: IPN), Exelixis (NASDAQ: EXEL), AstraZeneca (NASDAQ: AZN), and Synact Pharma (STO: SYNACT), among others, are actively involved in this space, reflecting a growing focus on both cancer control and symptom management. Additionally, the integration of digital health solutions and wearable technologies for symptom monitoring and management presents exciting opportunities for market expansion. However, challenges remain, including the need for standardized assessment tools for hot flash severity in men, limited awareness among some healthcare providers, and reimbursement barriers for symptom-focused treatments. DelveInsight's analysis emphasizes that companies developing therapies for hot flashes in prostate cancer patients should focus on interventions that not only reduce symptom frequency and severity but also maintain the therapeutic efficacy of anticancer treatments. The increasing recognition of hot flashes as a legitimate treatment target rather than merely an acceptable side effect represents a paradigm shift in prostate cancer management, opening new avenues for therapeutic development and market growth. Table of Contents 1. Key Insights 2. Executive Summary of Hot Flashes in Prostate Cancer 3. Hot Flashes in Prostate Cancer Competitive Intelligence 4. Hot Flashes in Prostate Cancer: Market Overview at a Glance 5. Hot Flashes in Prostate Cancer: Disease Background and Overview 6. Patient Journey 7. Hot Flashes in Prostate Cancer Epidemiology and Patient Population 8. Treatment Algorithm, Current Treatment, and Medical Practices 9. Hot Flashes in Prostate Cancer Unmet Needs 10. Key Endpoints of Hot Flashes in Prostate Cancer Treatment 11. Hot Flashes in Prostate Cancer Marketed Products 12. Hot Flashes in Prostate Cancer Emerging Therapies 13. Hot Flashes in Prostate Cancer: Seven Major Market Analysis 14. Attribute analysis 15. 7MM: Market Outlook 16. Access and Reimbursement Overview of Hot Flashes in Prostate Cancer 17. KOL Views 18. Hot Flashes in Prostate Cancer Market Drivers 19. Hot Flashes in Prostate Cancer Market Barriers 20. Appendix 21. DelveInsight Capabilities 22. Disclaimer 23. About DelveInsight About DelveInsight DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Arpit Anand Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
Yahoo
21-04-2025
- Business
- Yahoo
Fulgent Genetics Inc (FLGT) Q4 2024 Earnings Call Highlights: Strong Revenue Growth Amid ...
Full Year Core Revenue: $281.2 million, a growth of 7% compared to 2023. Fourth Quarter Revenue: $76.2 million, up from $70.5 million in Q4 2023. GAAP Loss for 2024: $42.7 million or $1.41 per share. Non-GAAP Income for 2024: $15 million or $0.49 per share. Fourth Quarter GAAP Gross Margin: 41.8%. Fourth Quarter Non-GAAP Gross Margin: 44.2%. Fourth Quarter Adjusted EBITDA: $774,000. Fourth Quarter Non-GAAP Income: $1.2 million or $0.04 per share. Cash and Equivalents: $828.6 million at year-end. 2025 Core Revenue Guidance: Approximately $310 million, representing 10% growth year-over-year. 2025 Expected Non-GAAP Gross Margin: Slightly exceed 40%. 2025 Expected Non-GAAP Operating Margin: Approximately minus 15%. 2025 Expected GAAP EPS: Loss of approximately $1.95 per share. 2025 Expected Non-GAAP Loss: $0.65 per share. 2025 Expected Cash Position: Approximately $780 million. Warning! GuruFocus has detected 3 Warning Signs with FLGT. Release Date: February 28, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Fulgent Genetics Inc (NASDAQ:FLGT) reported a 14% year-over-year growth in the fourth quarter and slightly exceeded their annual core revenue guidance of $280 million. The company has shown growth in its laboratory service business and has good momentum going into 2025. Fulgent Genetics Inc (NASDAQ:FLGT) has made significant advancements in therapeutic development, including the initiation of Phase 2 clinical trials for FID-007 and the clearance of an investigational new drug application for FID-022. The company has launched new products, such as the exome and genome RISE, which could potentially increase diagnostic yield by as much as 30%. Fulgent Genetics Inc (NASDAQ:FLGT) has formed a new partnership with Foundation Medicine, which is expected to enhance their precision diagnostics offerings. The company reported a GAAP loss of $42.7 million for 2024, translating to a loss of $1.41 per share. Fulgent Genetics Inc (NASDAQ:FLGT) expects a non-GAAP operating margin of approximately minus 15% for 2025 as they continue to invest in business growth. The company's biopharma services, while showing growth, still experience large swings quarter-to-quarter, indicating variability and potential instability. Fulgent Genetics Inc (NASDAQ:FLGT) anticipates a cash burn of approximately $25 million for their therapeutics development business in 2025. The company has not included potential revenue from new partnerships, such as with Foundation Medicine, in their 2025 guidance, indicating uncertainty in realizing these opportunities. Q: What are the key milestones for FID-007, and do you see head and neck cancer as the biggest opportunity? A: Ming Hsieh, CEO, explained that the clinical trial for FID-007 is expected to enroll 46 patients, with costs around $10 million. Preliminary results are promising, and further data will be presented at the ASCO meeting. While head and neck cancer is a significant opportunity, they are also exploring other indications. Q: Was there any one-time event contributing to the 14% year-over-year growth in Q4, and why is there a slowdown expected in 2025? A: Brandon Perthuis, CCO, clarified that the growth was due to market share gains rather than one-time events. The expected slowdown in Q1 2025 is due to seasonality, such as healthcare benefits resetting and adverse weather events, not macro issues. Q: Can you elaborate on the revised plan that led to 9% sequential growth in anatomic pathology? A: Brandon Perthuis, CCO, stated that the revised plan focused on targeting the dermatopathology market due to national issues with turnaround times. Their team delivered faster results, capturing significant market share. They plan to continue scaling the sales team to maintain momentum. Q: With the strong Q4 performance, is there potential upside to the 2025 guidance, especially with new wins like VA and Foundation Medicine? A: Brandon Perthuis, CCO, mentioned that while the guidance is based on clear visibility, new partnerships like Foundation Medicine are not yet fully baked into the numbers. There is potential upside as these partnerships develop and contribute to revenue. Q: How should we think about the cash utilization for clinical trials and pharma efforts in 2025? A: Ming Hsieh, CEO, indicated that the expected cash burn for the therapeutics development business is around $25 million for 2025. They are efficiently using funds to develop critical drugs, with promising results expected to be published at ASCO. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
