HPV E7

FOSTER CITY, Calif., April 28, 2025 /PRNewswire/ -- Adela, Inc., an innovator in blood testing for molecular residual disease (MRD) monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, presented initial results demonstrating the ability of its MRD test to predict recurrence in early-stage non-small cell lung cancer, at the American Association for Cancer Research (AACR) Annual Meeting from April 25-30, 2025. Adela's MRD test is a blood-only, tissue-free approach for detecting recurrence prior to clinical exam and imaging, eliminating the need for tumor tissue samples and enabling broader access to MRD testing. A blood-only approach is especially important in lung cancer, where nearly 40% of patients do not have sufficient tumor tissue for tissue-informed MRD tests.1 The ability of Adela's test to quantify cfDNA cancer signal and predict recurrence was evaluated in 136 samples from 24 patients diagnosed with stage I-II non-small cell lung cancer treated at New York University Langone Medical Center. Blood draws occurred prior to surgery, after surgery and at intervals before recurrence or last clinical follow-up. Adela's test demonstrated the ability to identify recurrences up to 35.9 months before standard of care clinical exam and imaging, with a mean lead time of 16.6 months. Significant differences in recurrence-free survival (RFS) were observed when patients were stratified by MRD positivity (hazard ratio of 3.58, P=0.038). "We are greatly encouraged by these results which highlight the ability of Adela's tissue-free MRD test to detect recurrence in lung cancer well in advance of standard of care," said Dr. Anne-Renee Hartman, Chief Medical Officer of Adela. "Adela's MRD test has been clinically validated for head & neck cancer. These results further validate the strong performance of Adela's genome-wide methylome enrichment platform and demonstrate its applicability across multiple cancer types." Adela's MRD test based on its genome-wide methylome enrichment platform is currently available to biopharmaceutical companies and other investigators for Research Use Only (RUO), including for biomarker discovery and drug development. Adela plans to commercialize the test in 2025 for use in patients who have received curative intent treatment for head & neck cancer, regardless of HPV status, to detect recurrence earlier and help guide treatment decision-making. Presentation Details Abstract #: 3249: The Development of a Tissue-Agnostic Genome-Wide Methylome Enrichment Assay for Lung Cancer Harvey I. Pass2 Monday Apr 28, 2025 2:00 PM - 5:00 PM Poster Section 29, Poster Board Number: 14 About Adela Adela is developing best-in-class technology to accelerate the diagnosis and improve the management of cancer through blood tests for minimal residual disease (MRD) monitoring and multi-cancer early detection (MCED). Adela's blood-based, tissue-free product ensures universal accessibility to MRD testing for patients with cancer, eliminating any dependency on tumor tissue availability. Adela's approach efficiently captures extensive, biologically-relevant genomic information from the methylome, providing greater opportunity to detect cancer signals in the blood compared to platforms that target a smaller set of genomic regions. Adela's first product utilizing this genome-wide methylome enrichment platform was recently clinically validated for predicting and surveilling for recurrence in patients with head & neck cancer and published in Annals of Oncology. Adela's investors are F-Prime Capital, OrbiMed, Deerfield Management, Decheng Capital, RA Capital Management and Labcorp. Find more information at adelabio.com. 1 Sam Khan et al. ctDNA-Lung-DETECT: ctDNA outcomes for resected early stage non-small cell lung cancers at 12 months.. JCO 42, 8018-8018(2024). DOI:10.1200/JCO.2024.42.16_suppl.8018 2 Department of Cardiothoracic Surgery, NYU Langone Medical Center New York, NY SOURCE Adela WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

A program to screen women for cervical cancer using AI has been launched in Ho Chi Minh City in Vietnam. Community organisation Ho Chi Minh City Public Health Association (HPHA) partnered with listed Australian company TruScreen and its local distributor Gorton Health Services to run the community-based program, which aims to screen 260,000 women in the city over five years. The partnership follows the signing of their initial memorandum of understanding in November. WHAT IT'S ABOUT The program will utilise TruScreen's cervical cancer screening device, which is powered by AI and has shown comparable accuracy to HPV DNA tests and liquid-based cytology. HPHA will hold screenings for women aged between 30 and 49 at the gynaecology clinics of the District Health Centres and private clinics while collecting epidemiological data on cervical cancer and pre-cancer. Tu Du Hospital, Hung Vuong Hospital, and Ung Buou Hospital will reportedly provide technical support. There is also a plan to expand the program to other provinces across Vietnam after the Ho Chi Minh City pilot. WHY IT MATTERS Around 4,000 Vietnamese women get diagnosed with cervical cancer each year, with around half dying. Given this significant burden, the Vietnamese government had set a goal of screening 60% of women aged 30-54 for cervical cancer, or an addressable population of 36 million. However, only a quarter of them have been screened over the past five years. Meanwhile, HPV vaccination is yet to be included in Vietnam's national immunisation schedule; the free administration of HPV vaccines will only start in 2026. The HPHA chose TruScreen's non-invasive AI-powered solution to address the need for early, rapid cervical cancer detection in large populations without costly cytology or laboratory infrastructure. "This HPHA screening program will also serve as an important reference site for neighbouring countries who may be considering a similar large-scale screening program to improve women’s health," added TruScreen CEO Marty Dillon. THE LARGER TREND Last year, Fujifilm opened in Vietnam its first cancer-focused health screening centre in Southeast Asia. The NURA centre, run by Vietnam Japan Health Technology, also leverages AI to support cancer and lifestyle disease screening. Besides Vietnam, China is another Asian country that utilises AI in cervical cancer screening. In 2019, the China Maternal and Child Health Care Association and Wuhan University introduced an AI and cloud-based diagnostic platform to assist with the country's expanded cervical cancer screening coverage. In other related news, a new AI-driven cervical cancer diagnostic system was granted regulatory approval in the United States. Last year, Hologic received the US Food and Drug Administration's clearance for its digital cytology system, which integrates deep learning and advanced volumetric imaging technology to detect pre-cancerous lesions and cervical cancer cells. This diagnostic tool has also been made available in Australia and New Zealand.

A panel of experts who decide the national immunization schedule will meet on Tuesday for the first time in 2025, providing an opportunity for the nation’s top vaccine scientists to publicly discuss the value of products that the new administration has cast doubt on. The CDC’s Advisory Committee on Immunization Practices meeting was postponed from February and is one of three scheduled for this year. The group is expected to discuss a number of vaccines, including shots protecting against the flu, Covid-19, RSV and meningitis. The group will vote on updated recommendations for chikungunya vaccines, meningococcal vaccines for teens and young adults, and RSV vaccination for adults. The administration’s scrutiny of these routine meetings reflects how much anti-vaccine sentiment has risen in recent years, and how HHS Secretary Robert F. Kennedy Jr. stands to reinforce those concerns. “I’m just praying that there will be an ACIP meeting,” Laura Riley, a former ACIP member and chair of obstetrics and gynecology at Weill Cornell Medicine, said in an interview on Monday. A spokesperson for HHS did not immediately respond when asked about Kennedy’s views of the committee and whether he plans to replace members in the future. Vaccine policy in the US is effectively divided into two parts. The FDA and its own advisory group review and decide what vaccines to approve. The CDC and ACIP recommend which Americans should get the approved vaccines. Recommended vaccines are usually covered by insurance. The decisions that ACIP makes, which the CDC director ultimately has final say over, are based on a number of factors, primarily the safety and efficacy of the vaccine. But the committee also considers the cost-effectiveness of the vaccine and the ethics of how certain recommendations, or lack thereof, will impact uptake. The committee reviews vaccine safety data post-licensure, and considers them when updating recommendations. “Unfortunately, there are so much data out there, and people are not aware of how to interpret it, which is why you need an advisory committee like ACIP poring through all of the data in order to make informed decisions,” said Henry Bernstein, a pediatrics professor at the Zucker School of Medicine at Hofstra University and another former ACIP member who served from 2017 to 2021. Not in recent memory has ACIP existed under an administration that so frequently questions the benefits of vaccination. Kennedy leads a separate MAHA Commission that he tasked with investigating the childhood vaccine schedule. He’s continuously questioned whether vaccines are the source of rising autism rates, and has initiated plans for the CDC to study just that, despite numerous studies concluding they do not. Specific kinds of vaccines, including mRNA-based and single-antigen vaccines, have been singled out by either Kennedy or key voices in the MAHA movement he leads. Riley said that acceptance of the committee’s work boils down to effective communication, which she says could be improved. “I don’t think people understand the benefits of science period,” Riley said. “I don’t think that we have communicated clearly enough how important scientific discovery is.” She pointed to the Covid pandemic as a time when the committee could have more directly explained what it did and didn’t know, given how swiftly new data about the vaccines and the virus were being produced. “I don’t think that it was clear to people that we didn’t know everything,” she said, adding that it created a vacuum for alternative sources of information to seep in. Sometimes the decisions themselves were polarizing, like when the committee decided in June 2021 that the benefits of the two-shot mRNA Covid vaccine regimen in men outweighed the risk of vaccine-related heart inflammation known as myocarditis. Kennedy has also questioned whether federal vaccine advisors have a too-cozy relationship with industry. Politico previously reported he was considering replacing some members because of their perceived conflicts. Former ACIP members dismissed the concern, saying the required conflict of interest submissions before each meeting were rigorous and that members frequently erred on the side of caution. Arthur Reingold, a former committee member and an epidemiology professor at the University of California, Berkeley, told Endpoints News that he was barred from voting on a vaccine against HPV because his wife was the director of the CDC’s division of sexually transmitted diseases at the time. “So if people are saying that all of that was basically hiding things or not fully transparent, I don’t know where that accusation comes from, frankly, or what it’s based on,” he said. The CDC now publishes past conflict of interest disclosures. Moving forward, Bernstein hopes there isn’t “dramatic change” to the group, calling its work “incredibly successful.” “What’s being done is critically important, but if we don’t communicate and educate the public at all levels around these vaccines, it’s going to be problematic,” he said. Editor’s note: This story was updated to include the full titles of Henry Bernstein and Arthur Reingold.