Latest news with #LDT
CNBC
5 days ago
- 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
Yahoo
01-04-2025
- Health
- Yahoo
Federal Court 'Vacates in Its Entirety' the FDA's Costly and Onerous Lab Test Rule
A federal district court has struck a blow for medical innovation and patient empowerment by overruling the Food and Drug Administration's (FDA) misbegotten effort to regulate laboratory-developed (LDTs) and in vitro testing. LDTs are diagnostic in vitro tests for clinical use that are designed, manufactured, and performed by individual laboratories. They can diagnose illnesses and guide treatments by detecting relevant biomarkers in saliva, blood, or tissues; the tests can identify small molecules, proteins, RNA, DNA, cells, and pathogens. For example, some assess the risks of developing Alzheimer's disease, detect the presence of cancers, or guide the treatment of breast cancer. Last May, the agency adopted extensive new rules aimed at regulating those tests for the first time. This is the same agency whose bureaucratic acumen in 2020 massively screwed up COVID-19 diagnostic testing as the pandemic rolled in. As I reported at the time, out of the billions of tests given annually, the FDA sought to justify imposing its burdensome oversight by citing problematic medical device reports and unconfirmed "allegations" for a grand total of nine and four different tests respectively between 2009 and 2023. The remaining examples cited by the FDA are tests that had actually been submitted to the agency for analysis and were subsequently rejected or revised as recommended. Various clinical and professional organizations including the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) strenuously opposed the FDA's regulatory overreach. Subsequently, they sued the agency in U.S. District Court for the Eastern District of Texas. Now, Judge Sean Jordan has ruled in favor of the laboratory representatives, setting aside the case "in its entirety" and remanding the matter to the secretary of Health and Human Services (HHS), now Robert F. Kennedy Jr., for further consideration. In his opinion memorandum, Judge Jordan pointedly notes that the FDA actually admits that administering its new LDT regulatory scheme would be costly and slow. FDA recognizes that the final rule will impose major burdens on laboratories. In fact, the new requirements will initially affect about 79,114 existing tests offered by 1,181 existing laboratories. AR318. Going forward, it will continue to affect about 10,013 new tests every year. The final rule also substantially increases FDA's workload. Even assuming that FDA will adhere to its non-binding enforcement discretion policies, FDA estimates that it will need to review an additional 103 premarket applications, 1,090 premarket notifications, and 267 de novo classification requests each year—an across-the-board increase that includes more than doubling the number of premarket applications subject to review. FDA estimates that the compliance costs for laboratories will total well over $1 billion per year. Over the next two decades, FDA projects that total costs associated with the rule will range from $12.57 billion to $78.99 billion. Without going too deeply into the legal details, Judge Jordan accepted the industry arguments that the existing Clinical Laboratory Improvement Amendments (CLIA) had established the appropriate and adequate system for regulating the quality, safety, and efficacy of LDTs and that the FDA has no statutory authority over LDTs. "The court's ruling ensures that clinical laboratories can continue to focus on their primary mission—offering innovative and reliable diagnostics that save and improve the lives of millions of patients every day," said ACLA President Susan Van Meter in a press release. "This is a victory that protects patient access to critically needed testing services and removes burdensome regulations that would have undermined the clinical laboratory system in this country." RFK Jr. should accept the court's ruling and immediately instruct the FDA to halt any further efforts to regulate LDTs and in vitro tests. The post Federal Court 'Vacates in Its Entirety' the FDA's Costly and Onerous Lab Test Rule appeared first on
Yahoo
01-04-2025
- Health
- Yahoo
Association for Molecular Pathology Celebrates U.S. District Court's Decision to Vacate FDA Rule on Laboratory-Developed Test Procedure Regulation
Professional society will continue to work with stakeholders to develop a more effective and efficient legislative regulatory framework that ensures high-quality patient care while fostering rapid innovation and the promise of new diagnostic technologies ROCKVILLE, Md., March 31, 2025 /PRNewswire/ -- The Association for Molecular Pathology, the premier global molecular diagnostic professional society, and pathologist Michael Laposata, M.D., Ph.D., today announced a favorable ruling in their lawsuit against the U.S. Food and Drug Administration over the regulation of laboratory-developed test procedures. The ruling by Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas granted AMP's motion for summary judgment and vacated the FDA rule that would have regulated LDTs as medical devices under the Federal Food, Drug and Cosmetic Act. AMP President Jane S. Gibson, Ph.D., is a Pegasus-awarded professor of pathology, chair of the Department of Clinical Sciences and director of molecular diagnostics at the University of Central Florida College of Medicine. "AMP is extremely pleased with the court's clear and decisive ruling in our favor, and we hope this will finally end the FDA's attempts to exert an unwarranted overreach of authority of LDTs," said Gibson. "This judgment is a significant victory for our members and for patients across the country. The decision to vacate the FDA rule will avoid adding billions of dollars to healthcare costs and protect access to high-quality care for hundreds of millions of Americans." For decades, LDTs have led to significant clinical advancements and diagnostic breakthroughs in rare and infectious diseases, human genomics, oncology biomarker testing and more. They are often created in response to recent medical advances and unmet clinical needs, and have been instrumental for early and precise diagnosis, disease monitoring and treatment guidance. LDTs are designed, developed, validated, performed and interpreted by highly trained medical and scientific experts in regulated clinical laboratories. Importantly, LDTs are not manufactured, packaged or commercially distributed like medical devices. Eric Konnick, M.D., is AMP's Professional Relations Committee chair and an associate professor and the associate director of the Genetics and Solid Tumor Laboratory at the University of Washington Department of Laboratory Medicine and Pathology. "The FDA LDT rule would have created an undue burden on laboratories tasked with keeping patients healthy and safe, and would have led to extensive additional requirements in addition to the existing CLIA regulations," said Konnick. "AMP members continue to work with key stakeholders to develop a more effective and efficient legislative framework that clarifies oversight, enhances transparency, preserves innovation, avoids escalating costs and ensures widespread patient access for these essential medical services." AMP has long maintained that the best approach to ensuring the continued development and deployment of accurate and reliable LDT procedures —and the correct utilization, precise interpretation and proper application of molecular test results — is through clarifying the current CLIA regulations. AMP's legislative proposal builds on the existing oversight framework and offers test quality enhancements where appropriate. To read the full ruling, please visit the AMP website. ABOUT AMPThe Association for Molecular Pathology was founded in 1995 to provide structure and leadership to the emerging field of molecular diagnostics. AMP's more than 3,100 members practice various disciplines of molecular diagnostics, including bioinformatics, infectious diseases, inherited conditions and oncology. Our members are pathologists, physicians, clinical laboratory directors, basic and translational scientists, technologists and trainees who practice in a variety of settings, including academic and community medical centers, government and industry. Through the efforts of its board of directors, committees, working groups and members, AMP is the primary resource for expertise, education and collaboration in one of the fastest-growing fields in healthcare. AMP members influence policy and regulation on the national and international levels, ultimately serving to advance innovation in the field and protect patient access to high-quality, appropriate testing. For more information, visit and follow AMP on X: @AMPath. MEDIA CONTACT:Andrew Nobleanoble@ View original content: SOURCE Association for Molecular Pathology Sign in to access your portfolio
