Latest news with #LDT
5 days ago
- Science
These 3 meteor showers are happening in late July: What to know
It may be the best time of year for stargazers to witness meteors blazing through the night sky. Late July will offer the chance to witness three separate meteor shower events happening at the same time, according to the American Meteor Society (AMS). Adding to the sky show, the moon will be in the evening sky and set before meteor activity is strongest, meaning its brightness won't diminish the visibility of the meteors, according to AMS. For best viewing, NASA advises spectators to lie flat on their backs in a region away from light pollution. Meteors should be visible after about 30 minutes, when eyes adjust to the darkness. The Alpha Capricornids The Alpha Capricornids are one of the two meteor showers peaking in late July. The minor shower began on July 7 and will last through Aug. 13, but is expected to peak on July 30, according to AMS. The Alpha Capricornids are known to produce fireballs -- typically three to five an hour, at maximum, astronomers say. Most of the shower members are faint, but some can appear brighter than any of the surrounding stars, according to AMS. The meteors appear slow-moving. In late July, the meteors radiate near the area of Alpha Capricorni, a double star visible to the naked eye. This area of the sky rises in the east at about 8 p.m. Local Daylight Time, but very little activity can be seen at this time because many of the meteors are blocked by the horizon. Astronomers recommend waiting to view the Alpha Capricornids until later at night, when the radiant -- where the meteor appears to originate from -- has gained more altitude and the moon has set, according to AMS. The radiant lies highest in the sky between midnight and 1 a.m. LDT. To find them at this time, look south. The Southern Delta Aquariids Night owls will benefit when searching for the Southern Delta Aquariids, according to AMS. To see them, look toward the radiant near southwestern Aquarius, just west of the star known as Delta Aquarii, about 40 degrees east of the Alpha Capricornids. They rise at about 10 p.m. LDT and are highest in the sky around 3 a.m. LDT. They will reach maximum activity on July 30 -- the same night as the Alpha Capricornids, according to AMS. But they are easier to differentiate from the Alpha Capricornids because they are much faster -- typically less than a second. Hourly rates around 3 a.m. on the morning of July 30 should be about five to 10 meteors, according to AMS. However, in the southern hemisphere, where the radiant lies overhead, rates can reach between 10 and 20 meteors per hour. The Southern Delta Aquariids began on July 19 and will run through Aug. 13. The Perseids The Perseids, considered by astronomers to be the best meteor shower of the year, began on July 17 and are expected to last until Aug. 23, according to AMS. They typically peak in mid-August. They are known for their fireballs -- large explosions of light and color that persist longer than an average meteor streak, according to NASA. Fireballs are brighter and originate from larger particles of cometary material. The Perseids' "swift and bright" meteors often leave streaks of light and color behind as they track through the sky, according to AMS. They originate from the debris left behind by the comet Swift-Tuttle as it orbits the sun every 133 years. The Perseids can be viewed all over the night sky but are best seen from the Northern Hemisphere during the pre-dawn hours, according to NASA. To find them, look toward the constellation Perseus, where the radiant of the Perseids appears to originate. This year, the Perseids are expected to peak around Aug. 12, according to
Business News Wales
6 days ago
- Business
- Business News Wales
Welsh Revenue Authority Reports Total of £2bn in Revenue for Wales
Ruth Glazzard and Rebecca Godfrey The Welsh Revenue Authority (WRA) has announced £372 million in tax revenue for Wales during the last financial year. Publishing its Annual Report and Accounts for 2024 to 2025, the WRA passed the £2 billion mark for the total amount of tax collected since the start of operations in 2018. Revenue from Land Transaction Tax (LTT) and Landfill Disposals Tax (LDT) is re-invested by Welsh Government in public services, like the NHS and schools, in communities across Wales. The report focuses on the WRA's seventh year of operations. Highlights include: Over 56,000 LTT returns processed efficiently Tax recovery exceeded £2 million for the first time on LTT More than £34 million in tax collected for LDT Achieved spend within 1% of budget The WRA also reported on its work supporting Welsh Government in preparing for the Visitor Accommodation (Register and Levy) Etc. (Wales) Bill, providing the Welsh Treasury with operational insight to help develop the legislation. The WRA continued to grow capability and skills to deliver in these new areas of responsibility and it said it has been involving stakeholders from the industry in its work. Rebecca Godfrey The report marks the leadership transition from founding Chief Executive Officer (CEO), Dyfed Alsop, to Interim CEO, Rebecca Godfrey. She said: 'We continued to make progress in embedding what we call, 'Our Approach', a Welsh way of doing tax. This proactive way of supporting people to get things right resulted in the vast majority of people filing and paying the right tax the first time. 'We also innovated in current taxes by mitigating tax at risk. This is about helping people to put things right when they get their taxes wrong. We recovered a record amount of tax through this work. 'Continuing to support Welsh Government with a focus on visitor levy and national registration has also been a highlight. I'm proud of the important role we can play in leading on new public services for Wales.' The report closes the final year of the WRA's Corporate Plan 2022 to 2025. In April, the WRA published its latest corporate plan. Ruth Glazzard, Chair of the WRA, said: 'As we report on this period and look ahead with our next corporate plan, this feels like a pivotal moment in our evolution. 'We've continued to make strong progress with our current responsibilities. We've also made preparations to deliver new services on behalf of Welsh Government. We look forward to the next chapter as we deliver more for Wales.'
CNBC
29-05-2025
- Business
- CNBC
This start-up is lowering the chances of passing on life-threatening diseases to your children—but it will cost you
Biotech start-up Orchid is one of the few companies offering in-vitro fertilisation (IVF) patients the option to screen their embryos for severe genetic diseases before their pregnancy begins. "This technology is going to totally reshape how people have children," Orchid's CEO Noor Siddiqui told CNBC's The Edge in an interview. "I think it's going to become an option that more and more people will choose because there's just the opportunity to avoid a lot of catastrophic outcomes, and they don't want to roll the dice on their child's health," Siddiqui added. During IVF, a woman takes fertility hormones to suppress her natural menstrual cycle and increase the number of eggs in her ovaries. Once her eggs are collected, they are mixed with the sperm and fertilized in a lab. The viable embryos are then transferred to the uterus. Siddiqui says that Orchid has developed a new technology that sequences 99% of an embryo's entire genome before implantation in the womb and screens for over 1,200 monogenic conditions, as well as some polygenic diseases. "When you have an embryo sample, you have about 125 cells on day five, and the embryologist at the IVF lab sends us about five of those cells, and in those five cells, you only have about 10,000 times less than the amount of DNA that you would have in a blood or saliva sample. So, what we had to invent is a new amplification protocol, as well as a new computational pipeline," Siddiqui said. The embryo screening process takes between two and three weeks, after which patients receive a whole genome embryo report. Orchid's counselors go through the report and help patients decide which embryo to move forward. Despite having been cleared by the Federal Drug Administration as a laboratory developed test (LDT) and backed by geneticists like George Church and Carlos Bustamante, Orchid's procedure has failed to convince some. "These tests, in general, cost money, often not covered by insurance. And so increasingly, breast cancer, for instance, is becoming more a disease of the poor because people can afford to undergo IVF and screen out breast cancer mutations when they've had a family history of breast cancer. I think that raises a problem ethically," bioethicist and Columbia University professor Robert Klitzman told The Edge in an interview. Orchid currently charges $2,500 per embryo screening. That's in addition to the IVF process which, according to the U.S. Department of Health and Human Services, ranges from $15,000 to $20,000 for a single cycle and sometimes requires several attempts. To mitigate the costs, the company has a philanthropic program that patients on low incomes can apply for. Orchid's technology is now available nationwide in the U.S. except in New York state, where Orchid had applied for a license to operate at the time of the interview. Learn more about Orchid's technology by clicking the video above. IVF was conceived as a reproductive method for people with infertility issues, but over the past decade, other patient groups have turned to it to prevent passing on genetic conditions to their child.
Business Wire
22-05-2025
- Health
- Business Wire
Exact Sciences Highlights Innovations in Early Cancer Detection and Precision Oncology at ASCO 2025
MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced it will present ten abstracts at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30–June 3, 2025, in Chicago, Ill. Presentations include new data on the Oncodetect™ molecular residual disease (MRD) test, multi-cancer early detection (MCED) testing, the Oncotype DX Breast Recurrence Score® test, and the Cologuard® test that underscore Exact Sciences' expanding portfolio and commitment to advancing care through scientific excellence. 'The data Exact Sciences will present at ASCO 2025 reflect the scientific rigor and clinical significance of our expanding portfolio and pipeline,' said Dr. Rick Baehner, MD, chief medical officer, Precision Oncology at Exact Sciences. 'From MRD to MCED to CRC screening, we are advancing evidence-based innovations that help empower providers and deliver crucial answers to patients. Every study, partnership, and data point move us closer to a future where cancer is detected earlier and treated with greater precision.' Real-world evidence supporting the Cologuard test continues to grow, with ongoing research into repeat screening. New data from prominent experts and research groups reinforce the Oncotype DX® test as a trusted, evidence-backed tool, further affirming its role as the standard of care for predicting chemotherapy benefit for breast cancer patients. Building on more than a decade of experience with Cologuard and 20 years of leadership with the Oncotype DX test, Exact Sciences continues to advance the future of precision oncology and multi-cancer screening. New Data and Continuous Evidence Generation Underscore the Oncodetect Test's Power to Detect Cancer Recurrence. Data from the Beta-CORRECT study further strengthens the clinical foundation of the Oncodetect test, confirming its role in helping guide treatment decisions and surveillance strategies for patients with stage II–IV colorectal cancer1. Expanding on this evidence to multiple solid tumor types, Exact Sciences and Flatiron Health continue enrollment in a multi-year, prospective study evaluating how MRD testing can improve cancer monitoring and treatment decisions in community care settings. New Data Support Promise of MCED as Exact Sciences Prepares for LDT Launch. A modeling study found annual MCED testing could reduce late-stage cancer incidence by more than 40% and mortality by up to 18% in high-risk groups2. Additionally, the Falcon registry, a large, prospective real-world study of Exact Sciences' MCED test, will track 25,000 participants against a 50,000-person standard-care cohort to assess adoption, outcomes, and patient experience. These findings come as Exact Sciences prepares to launch Cancerguard™ EX, its MCED lab-developed test (LDT), in the second half of the year, marking a significant step in expanding access to earlier cancer detection. Exact Sciences abstracts at ASCO include: Precision Oncology The Association of Circulating Tumor DNA (ctDNA) with Recurrence in Patients with Stage II-IV Colorectal Cancer: The ꞵ-CORRECT Study Saturday, May 31, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 3590 Molecular Residual Disease (MRD) in Solid Tumors Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: TPS3186 Enhancing Recurrence Detection in Stage III Colorectal Cancer Patients Through Molecular Residual Disease Test-guided Surveillance: A Modeling Study Abstract number: e15600 Patient outcomes in WSG-ADAPT according to NATALEE and MonarchE risk criteria Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 601 Screening Adherence to repeat screening for colorectal cancer using the multi-target stool DNA test: Real-world analysis of patients from Federally Qualified Health Centers Saturday, May 31, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 3630 A decade of progress: Trends in 5-year survival across 17 cancer types Abstract number: e23262 The potential of multi-cancer early detection screening in reducing cancer incidence and mortality in high-risk groups: A modeling study Saturday, May 31, 2025, from 1:30 PM to 5:30 PM CT Abstract number: 10542 Falcon – Exact Sciences' multi-cancer early detection (MCED) real-world evidence (RWE) registry Saturday, May 31, 2025, from 1:30 PM to 5:30 PM CT Abstract number: TPS11189 Evaluation of plasma methylated DNA markers for detection HPV-positive oropharyngeal squamous cell carcinoma: a case control study Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 6057 Feasibility of vaginal tampons versus vaginal swabs in the collection of vaginal fluid for endometrial cancer testing Abstract number: e17617 References Hashimoto et al. The association of ctDNA with recurrence in patients with stage II-IV colorectal cancer: The β-CORRECT study. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. Chhatwal, J., Xiao, J., ElHabr, A., Tyson, C., Cao, X., Raoof, S., Fendrick, A. M., Ozbay, A. B., Limburg, P., Beer, T. M., Deshmukh, A., & Briggs, A. (2025). The potential of multi-cancer early detection screening in reducing cancer incidence and mortality in high-risk groups: A modeling study. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences helps give patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype DX® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. NOTE: Oncotype DX Breast Recurrence Score and Oncodetect are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences, Cologuard, and Cancerguard are trademarks of Exact Sciences. Forward-Looking Statement This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements regarding the performance characteristics and health care benefits of the Cologuard, Oncotype DX Breast Recurrence Score, Oncodetect, and Cancerguard EX tests in a commercial setting, as well as statements regarding the development and commercialization of Exact Sciences' pipeline tests. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Yahoo
19-05-2025
- Business
- Yahoo
Medicare Boosts Reimbursement for Oncocyte's Flagship Technology
New price of $2,753 for the GraftAssureCore™ assay increases total addressable market size and margin opportunity Brings pricing in line with existing competitive technology Expands market appeal for prospective FDA-cleared kitted product at transplant centers IRVINE, Calif., May 19, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp., (Nasdaq: OCX), a diagnostics technology company, today provided a positive update on pricing for its next-generation lab-developed test (LDT), GraftAssureCore. The new reimbursement rate strengthens the company's position in the growing transplant rejection testing market and suggests potential upside to its estimated $1 billion total addressable market. The Centers for Medicare & Medicaid Services (CMS) has improved its reimbursement rate to $2,753 per result. This represents an increase from the prior structure using an earlier version of the assay, which paid $2,222 for first-time testing of a patient and $1,029 for subsequent tests. GraftAssureCore1 is Oncocyte's lab-developed test (LDT), which is run at the company's CLIA-certified Nashville lab2. 'Over the past two years Oncocyte has made significant investments in improving the scalability and manufacturability of our workflow to support our kitted test program,' said CEO, Josh Riggs. 'Last fall, we transferred these improvements into our CLIA lab and submitted to MolDX3 for repricing. We are very pleased with the result.' The new rate for the optimized workflow sets a benchmark that can be used to establish a reimbursement pathway for its future kitted test, GraftAssureDx, which the company expects to submit for FDA review by the end of this year. This process, known as 'bridging,' would allow other labs, upon receipt of FDA marketing authorization by Oncocyte, to purchase the Oncocyte kits to perform the test themselves and bill Medicare at the same rate. 'We believe this new price reflects the value that our technology brings to the transplant community,' continued Mr. Riggs. 'Once we receive FDA authorization, the ability to run the test clinically and bill Medicare directly will drive much broader adoption of our technology. We look forward to providing transplant centers the opportunity to access a high-quality, FDA-cleared kit with established reimbursement.' "We are very excited about the future of our company and this technology," said Chief Science Officer Dr. Ekke Schuetz. "We believe that our activation of decentralized testing will enable broader use of dd-cfDNA, transforming it from a high-cost technology to a revenue generating solution for transplant institutions." Oncocyte provided a positive update on its FDA submission process and clinical trial in an announcement on April 30. The company noted that a Central Institutional Review Board approved its clinical trial, that final preparatory steps are underway at the first participating transplant centers, that it expects three of the top 10 U.S. transplant centers to participate in its trial, and that nearly 10% of annual U.S. transplant volume is represented in clinical trial site interest. Footnotes: (1) Oncocyte's flagship technology quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). The company's scientists in Germany and the U.S. have played a critical role over the past decade in developing the science that helped establish dd-cfDNA as a trusted biomarker of transplant rejection, and the company is now commercializing that technology using a market disruptive approach. Per recent rebranding announcements, GraftAssure is becoming the umbrella brand for the company's dd-cfDNA test portfolio. The company is in the process of rebranding its VitaGraft assay (also known as VitaGraft Kidney), which is a lab developed test, under the name GraftAssureCore. For purposes of this press release, references to 'GraftAssureCore' shall be deemed to include the test previously marketed as VitaGraft. The company is also in the process of rebranding its research-use-only (RUO) test kit, GraftAssure, as 'GraftAssureIQ,' and rebranding its future in-vitro diagnostic (IVD) test kit as 'GraftAssureDx.' (2) CLIA, or the Clinical Laboratory Improvement Amendments, is a federal program overseen by CMS that ensures laboratories meet quality standards when performing diagnostic testing on human samples. (3) MolDX is a program managed by Medicare contractor Palmetto GBA (Government Benefits Administrators) that reviews molecular diagnostic tests and decides whether they should be covered and reimbursed by Medicare. About OncocyteOncocyte is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. Investors may visit for more information. GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, and VitaGraft™ are trademarks of Oncocyte Corp. Forward-Looking StatementsAny statements that are not historical fact (including, but not limited to, statements that contain words such as 'will,' 'believes,' 'plans,' 'anticipates,' 'expects,' 'estimates,' 'may,' and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, Oncocyte's commercial progress, anticipated FDA submissions, the expectation that Oncocyte will receive FDA marketing authorization for GraftAssureDx, the belief that decentralized testing will enable broader use of dd-cfDNA, transforming it from a high-cost technology to a revenue generating solution for transplant institutions, the expectation that three of the top 10 U.S. transplant centers will participate in Oncocyte's trial, and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Oncocyte's third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients' use of any diagnostic tests Oncocyte or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the 'Risk Factors' and other cautionary statements found in Oncocyte's Securities and Exchange Commission (SEC) filings, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Investor Contact: Doug FarrellLifeSci Advisors LLCdfarrell@ 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
