SAGA Diagnostics® Announces U.S. Commercial Launch of Pathlight™ at ASCO 2025, Setting a New Standard for Ultra-sensitive and Early MRD Detection
MORRISVILLE, N.C.--(BUSINESS WIRE)-- SAGA Diagnostics, a pioneer in blood-based cancer detection and precision medicine redefining the standard for ultra-sensitive and early molecular residual disease (MRD) detection, today announced the U.S. commercial launch of its Pathlight test for the detection of residual disease and recurrence at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, May 30 - June 3.
Pathlight's baseline detection rate was 96% overall, and 94% in estrogen receptor-positive (ER+) breast cancer, which suggests clinical advantages over first generation ctDNA assays.
Pathlight is a first-of-its-kind, multi-cancer MRD platform, initially indicated for early breast cancer, that uses structural variants (SVs) as biomarkers. SVs are well-established hallmarks of cancer, arising from and contributing to genomic instability and oncogenesis. SVs, including breakpoints and rearrangements, are highly tumor- and patient-specific and often reflect the underlying tumor biology making them informative biomarkers for tracking disease.
Pathlight combines whole genome sequencing and proprietary algorithms and informatics optimized for the identification of stable SV breakpoints, generating a personalized genomic fingerprint for each tumor, which are subsequently orthogonally validated and tracked utilizing proprietary multiplex digital PCR to enable rapid, precise, efficient and quantitative MRD detection from a simple blood draw.
'By tracking structural variants — stable, unique, and tumor-defining fingerprints of each patient's cancer — Pathlight enables interception of recurrence at its most treatable and potentially curable stage,' commented Roopom Banerjee, Executive Chairman of SAGA Diagnostics. 'Our goal is to deliver the most accurate, trusted results that provide assurance and support confident, informed treatment decisions. Our published, peer reviewed data demonstrates the clinical validity of Pathlight in breast cancer and its potential power across all solid tumors and heme malignancies. SAGA has further partnered with leading clinicians, institutions, and biopharma to bring Pathlight to market and best serve patients.'
The clinical validity of Pathlight was established with samples collected in the TRACER (cTdna evaluation in eaRly breAst canCER) study, published in Clinical Cancer Research 1 in January 2025. In this retrospective analysis of 100 patients with stage I–III breast cancer of all subtypes receiving standard-of-care neoadjuvant and adjuvant therapy Pathlight demonstrated best-in-class clinical performance – with 100% sensitivity and 100% specificity, and a 13.7-month lead time to recurrence as confirmed by clinical presentation or imaging. Notably, Pathlight's baseline detection rate was 96% overall, and 94% in estrogen receptor-positive (ER+) breast cancer, which suggests clinical advantages over first generation ctDNA assays. Pathlight also delivered unparalleled sensitivity – breaking the 1ppm barrier and offers the potential to detect MRD at the earliest possible opportunity, to support individualized intervention directed towards cure.
'The vast majority of breast cancer patients are diagnosed with ER+ disease, and up to 25% will experience recurrence – often many years after completing curative-intent treatment,' said David Cescon, MD, PhD, medical oncologist and clinician scientist at Princess Margaret Cancer Centre, University Health Network and senior author of the paper. 'We know that continued improvement in outcomes for people diagnosed with early breast cancer will require a shift towards more individualized treatment. There is a critical need for MRD testing that is both ultra-sensitive and ultra-specific, to enable long-term surveillance and risk-aligned treatment decisions for each patient.'
Pathlight has been submitted for US Reimbursement via the MolDX Program and is analytically validated across multiple cancer types. The test is already being used successfully in clinical studies by top pharmaceutical companies and at preeminent academic institutions and national cancer centers.
SAGA Diagnostics and its collaborators will be presenting three abstracts highlighting Pathlight's performance in breast cancer, ovarian cancer and soft-tissue sarcoma at ASCO:
Abstract #11511| June 1 | 9:00 a.m. – 12:00 p.m. CDT
Title: Potential of tumor-informed ctDNA as an early predictor for relapse in advanced ovarian cancer
Abstract #5574 | June 2 | 11:30 a.m. – 1:00 p.m. CDT
Title: Detecting ctDNA using personalized structural variants to forecast recurrence in localized soft tissue sarcoma (STS)
Abstract #3057 | June 2 | 1:30 p.m. – 4:30 p.m. CDT
Title: NeoCircle: Investigating circulating tumor DNA dynamics as a predictor of survival in primary breast cancer
SAGA will also be showcasing the capabilities and partnership opportunities of Pathlight at its booth (#36150) during the conference.
References
Elliott MJ, Howarth K, Main S, et al. Ultrasensitive detection and monitoring of circulating tumor DNA using structural variants in early-stage breast cancer. Clin Cancer Res. 2025;31(8):1520-1532. doi:10.1158/1078-0432.CCR-24-3472
About Pathlight
Pathlight™ is a next-generation, tumor-informed multi-cancer molecular residual disease (MRD) test, initially indicated for commercial testing in breast cancer. Pathlight uses whole genome sequencing to identify large-scale genomic changes, called structural variants (SVs), and tracks them over time using a unique combination of NGS and digital PCR, enabling industry-leading sensitivity and specificity. By optimizing for SVs that are stable, truncal biomarkers, Pathlight enables ultrasensitive recurrence detection and treatment response monitoring from early stage to metastatic disease. Developed and marketed by SAGA Diagnostics, the test has been submitted for US Reimbursement via the MolDX Program and is being used in clinical studies by multiple top 10 pharmaceutical companies and leading academic institutions and national cancer centers. For more information, www.pathlightMRD.com.
About SAGA Diagnostics
SAGA Diagnostics® is redefining the early detection of molecular residual disease (MRD), empowering treatment decisions with greater insight and confidence. Pathlight™, the company's flagship product, is an ultra-sensitive, blood-based, multi-cancer MRD test that is now available for commercial use in the U.S. for patients with breast cancer. SAGA is partnering with pharmaceutical and biotechnology companies, as well as commercial entities to support early through late-stage cancer development programs across a range of cancer types. SAGA's headquarters and CLIA-certified laboratory is located in the heart of the life science ecosystem in Research Triangle Park, North Carolina. SAGA Diagnostics combines world-class genomic expertise with a leadership team deeply experienced in molecular residual disease (MRD), all aligned around a compelling mission of intercepting cancer at the earliest stages when it's most treatable. For more information, www.sagadiagnostics.com.
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Vertex Presents New Data on Benefits of ALYFTREK® and Importance of Achieving Lower Sweat Chloride Levels at the European Cystic Fibrosis Conference
- Oral presentation on outcomes following treatment with CFTR modulators show that improvements in CFTR function, as measured by lower sweat chloride, correlate with better outcomes for people with cystic fibrosis - - Oral presentation on new post hoc data from randomized, controlled and open-label trials suggest improved quality of life results with ALYFTREK compared to TRIKAFTA® – BOSTON, June 06, 2025--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data across multiple studies demonstrating positive clinical and quality of life benefits of treatment with CFTR modulators and, in particular, ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor), which is approved in the United States and United Kingdom and is currently under review with health authorities in the EU, Canada, Australia, New Zealand and Switzerland. 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Vertex also presented the results of a post hoc analysis from the Phase 3 randomized, controlled and open-label trials of ALYFTREK (abstract WS19.04) which suggest treatment with ALYFTREK is associated with improved health-related quality of life outcomes in adolescents and adults, and with improved CF symptoms and general functioning in children aged 6-11 years compared to patients treated with TRIKAFTA. "These new data further demonstrate that reducing sweat chloride via treatment with CFTR modulators drives improved CFTR function and may ultimately result in better outcomes for patients across a variety of measures," said Professor Isabelle Fajac, Pulmonologist, Professor of Physiology at APHP-Université Paris Cité, Paris, France. 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While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the 30s, but with treatment, projected survival is improving. Today Vertex CF medicines are treating over 75,000 people with CF in more than 60 countries on six continents. This represents approximately 2/3 of the diagnosed people with CF eligible for CFTR modulator therapy. 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ALYFTREK and TRIKAFTA are not recommended in patients with moderate hepatic impairment and should only be considered when there is a clear medical need and benefit outweighs risk. If ALYFTREK is used, monitor patients closely. If TRIKAFTA is used, use with caution at a reduced dosage and monitor patients closely HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported in the post marketing setting for TRIKAFTA. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue ALYFTREK or TRIKAFTA and institute appropriate therapy. 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The use in children under these ages is not recommended Please see full Prescribing Information, including Boxed Warning, for Alfytrek and Trikafta. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 15 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on LinkedIn, Facebook, Instagram, YouTube and X. Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Professor Isabelle Fajac, in this press release, and statements regarding Vertex's beliefs about the potential benefits of ALYFTREK and TRIKAFTA for people with CF, and expectations for the pilot donation program. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, the risks listed under the heading "Risk Factors" in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at and available through the company's website at You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN) View source version on Contacts Vertex Pharmaceuticals Incorporated Investors: InvestorInfo@ Media: mediainfo@ orInternational: +44 20 3204 5275 Sign in to access your portfolio
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Vertex Presents New Data on Benefits of ALYFTREK ® and Importance of Achieving Lower Sweat Chloride Levels at the European Cystic Fibrosis Conference
BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data across multiple studies demonstrating positive clinical and quality of life benefits of treatment with CFTR modulators and, in particular, ALYFTREK ® (vanzacaftor/tezacaftor/deutivacaftor), which is approved in the United States and United Kingdom and is currently under review with health authorities in the EU, Canada, Australia, New Zealand and Switzerland. These data were presented at this year's European Cystic Fibrosis Society's (ECFS) 48th European Cystic Fibrosis Conference held June 4-7, 2025, in Milan, Italy. During the conference, the Company presented data from a pooled analysis across CFTR modulators, including ALYFTREK, which demonstrate that reduction in sweat chloride (SwCl), and therefore greater restoration of CFTR function, is associated with improved outcomes in people with cystic fibrosis (CF). For all clinical outcomes in the study, SwCl levels below 60 mmol/L were associated with greater benefit including better and more stable lung function, fewer pulmonary exacerbations, better nutritional status and better quality of life. SwCl levels below 30 mmol/L generally demonstrated greater numerical benefit than all other groups, with confidence intervals that overlapped with the ≥30 to <60 mmol/L group. Vertex also presented the results of a post hoc analysis from the Phase 3 randomized, controlled and open-label trials of ALYFTREK (abstract WS19.04) which suggest treatment with ALYFTREK is associated with improved health-related quality of life outcomes in adolescents and adults, and with improved CF symptoms and general functioning in children aged 6-11 years compared to patients treated with TRIKAFTA. 'These new data further demonstrate that reducing sweat chloride via treatment with CFTR modulators drives improved CFTR function and may ultimately result in better outcomes for patients across a variety of measures,' said Professor Isabelle Fajac, Pulmonologist, Professor of Physiology at APHP-Université Paris Cité, Paris, France. 'Importantly, the data also indicate that ALYFTREK, which has been shown to deliver even greater reductions in sweat chloride than TRIKAFTA, may drive improved quality of life and other health-related outcomes above and beyond even what we've seen with CFTR modulators to date.' About Cystic Fibrosis Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 109,000 people, including 94,000 people in North America, Europe and Australia. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the 30s, but with treatment, projected survival is improving. Today Vertex CF medicines are treating over 75,000 people with CF in more than 60 countries on six continents. This represents approximately 2/3 of the diagnosed people with CF eligible for CFTR modulator therapy. In addition, we have established a pilot donation program in collaboration with Direct Relief to provide TRIKAFTA® to eligible people with CF in select lower-income countries. The program currently includes 14 countries across four continents. 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Cases of liver failure leading to transplantation and death have been reported in both clinical trials and the postmarketing setting in patients with and without a history of liver disease taking TRIKAFTA, a fixed-dose combination drug containing elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA), the same or similar active ingredients as ALYFTREK. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of TRIKAFTA. Assess liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating ALYFTREK or TRIKAFTA, then every month during the first 6 months of treatment, every 3 months for the next 12 months, and at least annually thereafter. Consider more frequent monitoring for patients with a history of liver disease or liver function test (LFT) elevations at baseline. Interrupt ALYFTREK or TRIKAFTA for significant elevations in LFTs or in the event of signs or symptoms of liver injury. Consider referral to a hepatologist. Follow patients closely with clinical and laboratory monitoring until abnormalities resolve. If resolved, resume treatment only if benefit is expected to outweigh risk. Closer monitoring is advised after resuming treatment. ALYFTREK or TRIKAFTA should not be used in patients with severe hepatic impairment (Child-Pugh Class C). ALYFTREK or TRIKAFTA is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B). ALYFTREK should only be considered when there is a clear medical need and benefit outweighs risk. If ALYFTREK is used, monitor patients closely. If TRIKAFTA is used, use with caution at a reduced dosage and monitor patients closely. WARNINGS AND PRECAUTIONS DRUG-INDUCED LIVER INJURY AND LIVER FAILURE Elevated transaminases have been observed in patients treated with ALYFTREK. TRIKAFTA, which contains the same or similar active ingredients as ALYFTREK, can cause serious and potentially fatal drug-induced liver injury. Liver failure leading to transplantation and death has been reported in patients with and without a history of liver disease taking TRIKAFTA. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of TRIKAFTA Assess LFTs (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating ALYFTREK or TRIKAFTA, then every month during the first 6 months of treatment, every 3 months for the next 12 months, and at least annually thereafter. Consider more frequent monitoring for patients with a history of liver disease or LFT elevations at baseline, or a history of elevated LFTs with drugs containing ELX, TEZ, and/or IVA Interrupt ALYFTREK or TRIKAFTA in the event of signs or symptoms of liver injury, which may include: Significant elevations in LFTs (e.g., ALT or AST >5x the upper limit of normal (ULN) or ALT or AST >3x ULN with bilirubin >2x ULN) Clinical symptoms suggestive of liver injury (e.g., jaundice, right upper quadrant pain, nausea, vomiting, altered mental status, ascites) Consider referral to a hepatologist and follow patients closely with clinical and laboratory monitoring until abnormalities resolve. If resolved, and if benefit is expected to outweigh risk, resume treatment with close monitoring ALYFTREK and TRIKAFTA should not be used in patients with severe hepatic impairment. ALYFTREK and TRIKAFTA are not recommended in patients with moderate hepatic impairment and should only be considered when there is a clear medical need and benefit outweighs risk. If ALYFTREK is used, monitor patients closely. If TRIKAFTA is used, use with caution at a reduced dosage and monitor patients closely HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported in the post marketing setting for TRIKAFTA. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue ALYFTREK or TRIKAFTA and institute appropriate therapy. Consider benefits and risks for the individual patient to determine whether to resume treatment PATIENTS WHO DISCONTINUED OR INTERRUPTED ELX-, TEZ-, OR IVA-CONTAINING DRUGS DUE TO ADVERSE REACTIONS ALYFTREK There are no available safety data for ALYFTREK in patients who previously discontinued or interrupted treatment with drugs containing ELX, TEZ, or IVA due to adverse reactions. Consider the benefits and risks before using ALYFTREK in these patients. If ALYFTREK is used in these patients, closely monitor for adverse reactions as clinically appropriate DRUG INTERACTIONS Use With CYP3A Inhibitors Exposure to vanzacaftor, tezacaftor, and deutivacaftor, or elexacaftor, tezacaftor, and ivacaftor are increased when used concomitantly with strong or moderate CYP3A inhibitors. The dose of ALYFTREK or TRIKAFTA should be reduced when used concomitantly with moderate or strong CYP3A inhibitors Use With CYP3A Inducers Following concomitant use of strong or moderate CYP3A inducers with ALYFTREK, exposures of vanzacaftor, tezacaftor, and deutivacaftor were decreased, which may reduce ALYFTREK effectiveness. Concomitant use with strong or moderate CYP3A inducers is not recommended Exposure to ivacaftor is significantly decreased and exposure to elexacaftor and tezacaftor are expected to decrease by concomitant use with CYP3A inducers, which may reduce therapeutic effectiveness of TRIKAFTA. Concomitant use with strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort, is not recommended CATARACTS Non-congenital lens opacities/cataracts have been reported in pediatric patients treated with TRIKAFTA, which contain ivacaftor (similar to an active ingredient in ALYFTREK). Baseline and follow-up ophthalmological examinations are recommended in pediatric patients initiating treatment ADVERSE REACTIONS ALYFTREK Serious adverse reactions that occurred more frequently with ALYFTREK than with ELX/TEZ/IVA in 2 or more patients (≥0.4%) were influenza (1.5%), increased AST (0.4%), increased GGT (0.4%), depression (0.4%), and syncope (0.4%) The most common adverse reactions occurring in ≥5% of patients and at a frequency higher than ELX/TEZ/IVA by ≥1% were cough, nasopharyngitis, upper respiratory tract infection, headache, oropharyngeal pain, influenza, fatigue, increased ALT, rash, increased AST, and sinus congestion TRIKAFTA Serious adverse reactions that occurred more frequently in patients treated with TRIKAFTA compared to placebo included rash (1% vs <1%) and influenza (1% vs 0%) The most common adverse reactions occurring in ≥5% of patients treated with TRIKAFTA and at a rate higher than placebo by ≥1% were headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, alanine aminotransferase increased, nasal congestion, blood creatine phosphokinase increased, aspartate aminotransferase increased, rhinorrhea, rhinitis, influenza, sinusitis, blood bilirubin increased, and constipation USE IN SPECIFIC POPULATIONS PEDIATRIC USE Safety and effectiveness have not been established for ALYFTREK in patients younger than 6 years of age, nor for TRIKAFTA in patients younger than 2 years of age. The use in children under these ages is not recommended Please see full Prescribing Information, including Boxed Warning, for Alfytrek and Trikafta. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 15 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on LinkedIn, Facebook, Instagram, YouTube and X. Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Professor Isabelle Fajac, in this press release, and statements regarding Vertex's beliefs about the potential benefits of ALYFTREK and TRIKAFTA for people with CF, and expectations for the pilot donation program. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, the risks listed under the heading 'Risk Factors' in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at and available through the company's website at You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN)
