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Business Wire
20 hours ago
- Health
- Business Wire
SAGA Diagnostics® Announces Medicare Coverage for Pathlight™ MRD Test in Breast Cancer Across All Subtypes
MORRISVILLE, N.C.--(BUSINESS WIRE)-- SAGA Diagnostics, a pioneer in blood-based cancer testing redefining the standard for ultra-sensitive molecular residual disease (MRD) detection, today announced that Palmetto GBA's Molecular Diagnostic Services Program (MolDX) issued a positive coverage decision for the Pathlight MRD test. Pathlight is covered for Medicare beneficiaries for recurrence monitoring in the surveillance setting for up to six years in patients with stage II-III breast cancer, including all subtypes: HR+/HER2-, HER2+ and TNBC. The Medicare local coverage determination follows a rigorous review of evidence demonstrating Pathlight's analytical and clinical validity and affirms the test's utility in improving standard-of-care management for patients with early-stage breast cancer. The coverage determination enables eligible Medicare beneficiaries to access the test when ordered by a healthcare provider. Breast cancer is the most common malignancy among women worldwide, and the second leading cause of cancer death in U.S. women 1. In the U.S. alone, approximately 300,000 women are expected to be diagnosed with breast cancer in 2025 2. Of these, roughly 90% present at early stages (I–III) 3, where timely intervention can improve outcomes. Notably, ~75% of all breast cancers are estrogen receptor-positive (ER+), making it the most prevalent molecular subtype 4. ER+ breast cancer can have a highly variable prognosis — with nearly 40% of patients characterized as high-risk 5 — which requires these patients to undergo long-term monitoring for relapse post-surgery. Currently available MRD tests have limited sensitivity in ER+ disease, especially at baseline (i.e., at diagnosis), highlighting a critical unmet need for early-stage patients with breast cancer who could be cured with timely and effective treatment. The coverage decision by the MolDX program was primarily based on evidence from the cTdna evaluation in eaRly breAst canCER (TRACER) study, published in Clinical Cancer Research 6 in January 2025. The TRACER study demonstrated Pathlight's excellent clinical performance across all subtypes of early-stage breast cancer. The study reported 100% sensitivity and 100% specificity, with a 13.7-month lead time prior to detection of recurrence by standard-of-care clinical methods, including imaging. The study also demonstrated a baseline detection rate of 96% across all subtypes in stage I-III breast cancer, and notably 94% in ER+ disease, which underscores its clinical advantages over currently available MRD tests. 'This Medicare coverage decision represents a pivotal moment for patients diagnosed with breast cancer – especially those with ER+ early-stage disease, who now have an ultra-sensitive test to monitor early for cancer recurrence,' said Roopom Banerjee, Executive Chairman of SAGA Diagnostics. 'Expanded access to Pathlight empowers patients and clinicians to make more personalized, informed treatment decisions to improve outcomes.' References 1. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. doi:10.3322/caac.21660 2. American Cancer Society. Cancer Facts & Figures 2024. Atlanta, GA: American Cancer Society; 2024. Available from: 3. Howlader N, Noone AM, Krapcho M, et al., eds. SEER Cancer Statistics Review, 1975–2020. Bethesda, MD: National Cancer Institute; 2023. Accessed May 5, 2025. 4. Prat A, Cheang MCU, Martín M, et al. Prognostic significance of progesterone receptor–positive tumor cells within immunohistochemically defined luminal A breast cancer. J Clin Oncol. 2013;31(2):203–209. doi:10.1200/JCO.2012.43.4134 5. Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61–70. doi:10.1038/nature11412 6. 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/ About Pathlight™ Pathlight™ is a novel, personalized, tumor-informed multi-cancer molecular residual disease (MRD) platform developed by SAGA Diagnostics. It delivers industry-leading sensitivity and specificity for detecting cancer recurrence and monitoring treatment response by analyzing circulating tumor DNA (ctDNA). Pathlight uses a proprietary combination of whole genome sequencing and digital PCR to identify and track large-scale genomic changes known as structural variants (SVs) – stable, truncal biomarkers that provide a clearer, earlier indication of disease recurrence. By optimizing for SVs, Pathlight enables ultra-sensitive detection of recurrence and precise monitoring of treatment response in early-stage and metastatic disease. This advanced approach empowers oncologists to make timely, confident decisions—helping patients avoid unnecessary treatments or receive interventions sooner when needed. Pathlight supports accurate, longitudinal assessments of disease status, enhancing care across the entire patient journey. Pathlight is covered by Medicare for early-stage breast cancer across all subtypes and is actively used in clinical studies by leading clinical institutions, national cancer centers and major pharmaceutical companies. For more information, visit 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 and reimbursed for patients with early stage 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 are 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 MRD, all aligned in the mission to intercept cancer at its earliest stages when it is most treatable. For more information, visit
UPI
24-07-2025
- Science
- UPI
SpaceX launches satellites from California, Florida day after scrubs
SpaceX launches TRACER satellites for NASA. July 23, 2025. SpaceX screenshot. July 23 (UPI) -- SpaceX launched two Falcon 9 rockets with satellite payloads after they were scrubbed less than a minute before liftoff one day earlier in Florida and California. In both situations, the rockets and payloads were in good health. On Wednesday, the private agency launched two Tandem Reconnection and Cusp Electrodynamics Reconnaissance Satellites, or TRACER, for NASA at 2:13 p.m. PDT from Vandenberg Space Force Base in California. The mission was scrubbed just 45 seconds before liftoff Tuesday because of Federal Aviation Administration "airspace concerns" in the Santa Barbara area, which is midway between San Francisco and Los Angeles. On Tuesday, SpaceX launched two O3b mPOWER satellites for Luxembourg-based SES from Cape Canaveral Space Station's Pad 40 in Florida at 5:12 p.m. EDT after the mission was scrubbed 11 seconds before liftoff. Vandenberg The "airspace concerns" were linked to a power issue at an FAA control center. "A regional power outage in the Santa Barbara area disrupted telecommunications at the Los Angeles Air Route Traffic Control Center, which manages air traffic over the Pacific Ocean," an FAA spokesperson said in a statement to SpaceFlight Now. "As a result, the FAA postponed the SpaceX Falcon 9 TRACERS launch on Tuesday, July 22. The FAA took this action to ensure the safety of the traveling public." The two TRACER satellites were deployed near each other to "help understand magnetic reconnection and its effects in Earth's atmosphere." They were deployed into a low-Earth orbit of 367 miles. Other payloads were the Athena EPIC, the Polylingual Experimental Terminal and the Relativistic Electron Atmospheric Loss. The REAL mission will explore high-energy particles in Earth's Van Allen radiation belts scattered in the atmosphere. Less than 8 minutes after liftoff, Falcon 9's first stage landed on SpaceX's Landing Zone 4 stationed in the Pacific Ocean. Cape Canaveral A reason wasn't given for the late scrubbing. About 8 1/2 minutes after liftoff, the booster landed on Just Read the Instructions droneship stationed in the Atlantic Ocean. The same first-stage booster launched the last two satellites for SES in December 2024. The booster was also involved in the NASA Crew-10 launch and two Statlink missions. SpaceX earlier launched eight satellites for the company into medium Earth orbit. They are stationed about 5,000 miles above Earth. It was SpaceX's 15th SES mission with the first one in 2013. The two mPOWER satellites were delivered by Boeing to Florida earlier this month. "This next-generation satellite network was designed to bring connectivity to the 'other three billion' -- those who lack consistent, reliable access to communications systems," SES said on its website. "For the first time, telcos connect entire island nations, remote industries access digital tools and governments conduct vital operations to the harshest terrains."
Yahoo
16-07-2025
- Business
- Yahoo
Voyager Adds Fourth Wholly-Owned Alzheimer's Disease Program to Pipeline, Complementing Existing Tau and Amyloid Assets with New APOE Approach
- New program combines IV-delivered TRACER™ capsid with bifunctional payload to silence APOE in carriers of the high-risk APOE4 variant while delivering the protective APOE2 variant - - Voyager's wholly-owned Alzheimer's disease franchise now includes clinical-stage anti-tau antibody VY7523 as well as gene therapies targeting tau, amyloid, and APOE - LEXINGTON, Mass., July 16, 2025 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to leveraging genetics to treat neurological diseases, today continued the expansion of its Alzheimer's disease (AD) franchise with the introduction of a wholly-owned program that modulates the expression of apolipoprotein E (APOE), the strongest genetic risk factor for AD.i The program uses a proprietary intravenous (IV)-delivered, blood-brain barrier (BBB)-penetrant TRACER capsid to deliver a bifunctional payload that is designed to decrease expression of APOE in carriers of the variant APOE4, while delivering the variant APOE2. APOE4 has been strongly linked with a higher risk of developing AD, with almost all APOE4 homozygotes exhibiting AD pathologyi, while APOE2 has been associated with a lower risk of developing AD. In preclinical studies, a single IV injection of a TRACER capsid carrying the single bifunctional vector resulted in significant reductions of endogenous APOE4 in key AD-relevant brain regions of APOE4 knock-in mice, while significantly increasing expression of the APOE2 isoform to maintain overall APOE levels. Voyager anticipates presenting early data on this program at an upcoming scientific meeting in 2025. 'The Voyager team is leveraging our deep expertise in Alzheimer's disease biology and drug development to advance multiple programs against what we believe to be the three most-promising targets: tau, amyloid, and APOE,' said Alfred W. Sandrock, Jr., M.D., Ph.D., Chief Executive Officer of Voyager. 'We believe each of these approaches will have an important role to play in the treatment of Alzheimer's disease, particularly as the field begins to understand how best to sequence and combine treatments to improve outcomes for patients. We look forward to near-term data on some of these targets expected from third parties, which we expect will continue to inform our Alzheimer's disease franchise and approach.' Voyager's AD franchise is now comprised of four wholly-owned assets: VY7523, a pathologic-specific anti-tau antibody, which is being evaluated in a multiple ascending dose (MAD) clinical trial in AD patients, with initial tau positron emission tomography (PET) data expected in the second half of 2026. VY1706, an IV-delivered tau silencing gene therapy that has shown up to 73% knockdown of tau mRNA in non-human primates following a single IV dose and is advancing towards IND in 2026. A vectorized anti-Aβ antibody gene therapy, which demonstrated over 15-fold greater brain-to-plasma ratio after a single IV dose compared to a passively administered antibody over 4 weeks in a murine model, as presented at the American Society of Gene & Cell Therapy's (ASGCT) 28th Annual Meeting. The APOE gene therapy program, which is designed to knock down APOE in APOE4 carriers while delivering APOE2 and maintaining total APOE levels. About the TRACER™ Capsid Discovery Platform Voyager's TRACER™ (Tropism Redirection of AAV by Cell-type-specific Expression of RNA) capsid discovery platform is a broadly applicable, RNA-based screening platform that enables rapid discovery of novel AAV capsids to enable gene therapy. Voyager has leveraged TRACER to create multiple families of novel capsids that, following intravenous delivery in preclinical studies, harness the extensive vasculature of the central nervous system (CNS) to cross the blood-brain barrier and transduce a broad range of CNS regions and cell types. In cross-species preclinical studies (rodents and multiple non-human primate species), intravenous delivery of TRACER-generated capsids resulted in widespread payload expression across the CNS at relatively low doses, enabling selection of multiple development candidates in Voyager's wholly-owned and partnered gene therapy programs for neurologic diseases. About Voyager Therapeutics Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer's disease, Friedreich's ataxia, Parkinson's disease, amyotrophic lateral sclerosis (ALS), and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; and Neurocrine Biosciences, Inc. For more information, visit Voyager Therapeutics® is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc. Forward-Looking Statements This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as 'will,' 'expect,' 'believe,' 'anticipate,' 'potential,' or 'continue,' and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding Voyager's continued expansion of its AD franchise by advancing multiple programs against tau, amyloid and APOE to treat AD and the potential to sequence and combine such treatments to improve therapeutic outcomes for patients; Voyager's ability to advance its AAV-based gene therapy programs and tau antibody program, including expectations for Voyager's achievement of preclinical and clinical development milestones for its potential development candidates such as the IND filings, the initiation of clinical trials, clinical trial enrollment, and the generation of clinical data; Voyager's ability to advance preclinical programs (i) against ApoE using a single IV-injected TRACER capsid to deliver a bifunctional payload to reduce endogenous ApoE4, as well as (ii) against amyloid by its vectorized anti-Ab antibody gene therapy. Voyager's plans to present scientific data at future conferences; the commercial potential for VY7523 and VY1706; the importance of tau as a target for the treatment of AD; and the potential for third-party clinical data to inform Voyager's clinical development plans are forward looking. All forward-looking statements are based on estimates and assumptions by Voyager's management that, although Voyager believes such forward-looking statements to be reasonable, are inherently uncertain and subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected. Such risks and uncertainties include, among others, the expectations and decisions of regulatory authorities; the timing, initiation, conduct and outcomes of Voyager's preclinical and clinical studies; the availability of data from clinical trials; the availability or commercial potential of product candidates under collaborations; the success of Voyager's product candidates; the willingness and ability of Voyager's collaboration partners to meet obligations under collaboration agreements with Voyager; the continued development of Voyager's technology platforms, including Voyager's TRACER platform and its non-viral discovery platform; Voyager's scientific approach and program development progress, and the restricted supply and increased costs of critical research components; the development by third parties of capsid identification platforms that may be competitive to Voyager's TRACER capsid discovery platform; Voyager's ability to create and protect intellectual property rights associated with the TRACER capsid and non-viral discovery platform, the ligands identified by the platform, and development and clinical candidates for Voyager's pipeline programs; the possibility or the timing of Voyager's receipt of program reimbursement, development or commercialization milestones, option exercise, and other payments under Voyager's existing licensing or collaboration agreements; the ability of Voyager to negotiate and complete licensing or collaboration agreements with other parties on terms acceptable to Voyager and the third parties; the success of programs controlled by third-party collaboration partners in which Voyager retains a financial interest; the ability to attract and retain talented directors, employees, and contractors; and the sufficiency of Voyager's cash resources to fund its operations and pursue its corporate objectives. These statements are also subject to a number of material risks and uncertainties that are described in Voyager's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission. All information in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Contacts Trista Morrison, tmorrison@ Investors: Sarah McCabe, smccabe@ Media: Adam Silverstein, adam@ ____________________________________i Fortea, J., Pegueroles, J., Alcolea, D. et al. APOE4 homozygosity represents a distinct genetic form of Alzheimer's disease. Nat Med 30, 1284–1291 (2024). in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
CBS News
17-06-2025
- Politics
- CBS News
Colorado suspends access to state election site to remove some information after Minnesota shootings
Colorado Secretary of State Jena Griswold closed off access to the state's online election database, known as "TRACER," over the weekend, amid concerns about publicly available private information about politicians in the aftermath of the politically-motivated shootings and killings in Minnesota. "Addresses and other personal information is on TRACER," Griswold said. "The reason it's on there is for public transparency. There is the ability for elected officials and candidates to request that their addresses are redacted, and so we wanted to give folks enough time to do that, and temporarily took TRACER down." The site is where political candidates post their information to comply with election finance requirements, among other information. The site Monday carried the message, "Down for maintenance," which Griswold pointed out, does happen from time to time. After a few seconds on the error message, the website redirects you to another elections landing page on the Colorado Secretary of State's Office's website. TRACER, Colorado's online elections database, was taken down by the Colorado Secretary of State's Office as election officials and elected officials review private information on the site after the politically-motivated killing of a state representative and her husband and the shooting of a state senator and his wife in Minnesota. CBS She said she had talked with legislative leadership and other statewide elected leaders about the existence of the information on the public database. "Out of abundance of caution, we wanted to make sure that officials had the ability to think about whether they wanted their addresses redacted," Griswold said. There are many places where people's private information can be potentially obtained online, but Griswold said the killing of a state representative and her husband and the shooting of a state senator and his wife in Minnesota made the review timely. Griswold herself has been the subject of repeated threats, particularly following the 2020 elections. Four people have been convicted of charges related to making threats directed at her. "It's coming from the real facts that elected officials are under increased threats. I myself received, just in 2024, over 1,800 death threats or physical threats. It is scary, and I think we have to take that as a fact of where this country is right now," she said. "And for me, weighing the choices of the safety of elected officials, Republicans and Democrats, and a brief outage of Tracer, that the choice was very clear." Griswold said she had asked lawmakers if they wanted information like home addresses, which is not required, to be removed. The process of redacting information was taking time, and she said the site would likely remain down, but for a period of days, not weeks.
17-06-2025
- Politics
After Minnesota shooting, some states are more tightly guarding officials' personal information
LOS ANGELES -- Lawmakers in some states are moving to delete their home addresses from online directories and Wisconsin legislators are seeking added security for a session this week after one Minnesota legislator was killed and another wounded in their suburban Minneapolis homes last weekend in what Gov. Tim Walz described as a targeted political attack. Vance Boelter is in federal custody facing murder and stalking charges in the shooting death of former Democratic House Speaker Melissa Hortman and her husband, Mark. Authorities say he also shot and wounded Sen. John Hoffman and his wife Yvette. Boelter, 57, also faces state murder charges. Authorities said Boelter had a list of dozens of state and federal elected officials in Minnesota and meticulous notes on the homes and people he targeted early Saturday. He also stopped by the homes of two other legislators that night, according to police. Authorities say he found their addresses in a variety of internet searches. The Minnesota Legislature's website lists the addresses of members' offices in the state capital of St. Paul, not their home addresses. On Saturday, the North Dakota Legislature's staff agency removed lawmakers' addresses from their biographical webpages as a result of the targeted attacks in Minnesota, Legislative Council Director John Bjornson said. Most North Dakota lawmakers opt to give a home, business or postal box address on their webpage, where the public also can find their email addresses and phone numbers. Removing addresses of elected officials is a difficult decision because they have to be approachable, open and transparent, said Burleigh County Sheriff Kelly Leben, whose county is home to North Dakota's capital city. 'I think it's a balancing act between being a public official and the safety of myself and my family,' the elected county sheriff said. All home addresses for New Mexico legislators were also removed from the Statehouse website as an immediate precaution, said Shawna Casebier, director of the Legislature's legal office. Personal information on the website already had been limited at the discretion of individual lawmakers in the aftermath of drive-by shootings at the homes of four Democratic state and local lawmakers in Albuquerque in 2022 and 2023. In Colorado, at least 31 elected officials have filed requests to remove their personal contact information from a public-facing state campaign finance database called TRACER, which was briefly taken down Saturday so those requests could be fulfilled. 'We did so out of an abundance of caution for the safety of elected officials in an unprecedented political climate,' Colorado Secretary of State Jena Griswold said in a statement. The Colorado development was first reported by Axios. Lawmakers in Wisconsin requested additional security for when the state Assembly meets on Wednesday, said Luke Wolff, spokesperson for Republican Assembly Speaker Robin Vos. Wolff did not detail what was requested or what changes may be made. The Wisconsin Capitol is one of the most open in the country, with public access seven days a week, no metal detectors, screening checkpoints or security badges required to gain entry. There are galleries in both the Senate and Assembly where the public can view legislative debate. Even before the Minnesota shooting, states in recent years have stepped up efforts to shield the personal information of officials in response to high-profile attacks. One day before the Minnesota killings, Oregon lawmakers passed a bill that would prohibit the Oregon Secretary of State from making the residential addresses of those associated with a candidates' campaign committee viewable by the public on its electronic filing system. The campaign filings would still be viewable online, but home addresses would be redacted, unless the person asks the Secretary of State's office to publish it. A public records request would need to be filed to obtain such addresses. Louisiana lawmakers passed a bill last week that adds statewide elected officials and legislators to the list of people who can ask that their personal information be removed from public records and the internet. Certain judges were already on the list. Officials can seek to have home addresses, phone numbers, email addresses, date of birth, marital status, school or daycare of their child, their place of worship or employment location of their spouse removed. Under current law, if person does not comply with the removal request, they can be sued and face up to 90 days in prison or $1,000 fine for the misdemeanor. The measure still needs final approval from Gov. Jeff Landry, one of the Louisiana officials whose private information would be protected. Georgia legislators passed a law earlier this year to require that home addresses of candidates who file campaign finance reports, including themselves, be redacted from by the state Ethics Commission from public view. The action came after a number of Georgia officials were targeted by swatting incidents in December 2023. Lawmakers also passed a second law which removes the personal phone number, home address, and property or tax records of a judge or their spouse from public view. Records covered include voter registration and corporation records. The Illinois State Board of Elections stopped publishing the street addresses of candidates for political office on its website last year, spokesperson Matt Dietrich said. Lawmakers had raised concerns after protestors picketed the home of Secretary of State Alexi Giannoulias, the state librarian, over legislation he pushed through the General Assembly that would cut state funding to libraries that ban books. Candidates' addresses remain on elections board documents that are no longer published on the web but accessible via public records request. In 2020, a gunman posing as a delivery driver shot and killed the 20-year-old son of U.S. District Judge Esther Salas in New Jersey and injured her husband at their family home. The state legislature passed a law later that year by that exempted the home addresses of current or retired judges, prosecutors and law enforcement officers from disclosure under public records laws. The measure, called Daniel's Law in honor of the judge's son, also allowed officials to ask websites to remove their home addresses. Maryland enacted a law in 2024 preventing individuals from publishing judges' personal information online after a circuit court judge was shot by a man hours after the judge ruled against him in a divorce case. Judges can submit requests to government entities and private websites to remove information like phone numbers, social security numbers, and personal emails.
