Latest news with #MRD
National Post
3 days ago
- Health
- National Post
LabPMM® Receives New York State Approval for the NPM1 MRD Assay - Informing Therapy and Accelerating Targeted Trials
Article content SAN DIEGO — Invivoscribe is happy to announce that its wholly owned subsidiary, the Laboratory for Personalized Molecular Medicine ® (LabPMM) has received approval from New York State (NYS) for the NPM1 MRD Assay. This approval comes just two months after gaining NYS approval for our FLT3 ITD MRD Assay. Together these tests represent a critical tool for patients with acute myeloid leukemia (AML), clinicians and pharmaceutical companies. This new approval underscores Invivoscribe's ongoing commitment to providing the most accurate, standardized measurable residual disease (MRD) testing solutions worldwide. Article content The NPM1 MRD Assay is a pivotal development in the fight against AML, offering an ultra-sensitive DNA sequencing method to accurately measure trace levels of residual leukemia cells in patients with the NPM1 mutation variants. NPM1 mutations are considered an ideal target for MRD assessment because they are present in ~30% of adult AML cases, 1 stable over time, 2 and, if present in blood at allele fractions ≥0.01%, are associated with increased relapse and worse overall survival. 3 Recent studies show emerging evidence that pre-transplant MRD testing for NPM1 and FLT3 -ITD identifies AML patients in remission who are most likely to relapse or experience poor survival. 3,4,5 With this approval, LabPMM is helping to transform the landscape of AML research, treatment and drug development. By using MRD as a surrogate endpoint in clinical trials, instead of relying solely on overall survival (OS), pharmaceutical companies can accelerate their drug development timelines. This is particularly valuable in acute disease, where time is of the essence, and earlier intervention can dramatically improve patient outcomes. Article content 'We are proud to receive New York State approval for our NPM1 MRD Assay by NGS, marking our second assay approved by New York State this year,' said Jordan Thornes, V.P., Global Clinical Laboratory Operations at LabPMM. 'This milestone reflects our continued dedication to advancing precision diagnostics in cancer care. With this latest approval, we're further empowering clinicians with sensitive, reliable tools to detect residual disease and guide treatment decisions with confidence.' Article content LabPMM's NPM1 and FLT3 ITD MRD Assays are standardized next generation sequencing (NGS) tests that complement the LeukoStrat ® CDx FLT3 Mutation Assay, which is used to guide treatment selection for patients with AML. These services are offered in the U.S., European Union, and across Asia to ensure patients around the world have access to high-quality, standardized testing and to support the development of cutting-edge cancer treatments. LabPMM remains committed to advancing precision medicine and improving outcomes for patients worldwide. For more information about the NPM1 MRD Assay and LabPMM's full test menu, please visit or contact us at inquiry@ and follow us on LinkedIn. Article content About Invivoscribe Article content Invivoscribe ® is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics ®. For thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with pharmaceutical companies interested in clinical trial testing via our global lab network located in the U.S., Germany, Japan and China, and in developing and commercializing companion diagnostics, with our rigorous expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM ®), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization. Article content Article content Article content Article content Article content Article content
ITV News
5 days ago
- Health
- ITV News
New leukaemia treatment hailed as ‘milestone' for patients
Scientists have hailed a 'milestone' in leukaemia care for patients after a UK trial found a chemotherapy-free approach to treatment may lead to better outcomes for some patients. The groundbreaking UK-wide trial could reshape the way the most common form of leukaemia in adults is treated. Researchers from Leeds wanted to assess whether two targeted cancer drugs could perform better than standard chemotherapy among patients with chronic lymphocytic leukaemia (CLL). They led the Flair trial, which took place at 96 cancer centres across the UK. Flair trial is a milestone. We have shown that a chemotherapy-free approach can be not only more effective but also more tolerable for patients Dr Talha Munir Some 786 people with previously untreated CLL were randomly assigned to receive standard chemotherapy; a single targeted drug, ibrutinib, or two targeted drugs taken together, ibrutinib and venetoclax, with treatment guided by personalised blood tests. They found that after five years, 94% of patients who received ibrutinib plus venetoclax were alive with no disease progression. This compares with 79% for those on ibrutinib alone and 58% for those on standard chemotherapy, according to the study, which has been published in the New England Journal of Medicine and presented to the European Haematology Association congress in Milan, Italy. Meanwhile 66% of patients on the new combination had no detectable cancer in their bone marrow after two years, compared with none of the people who received ibrutinib alone and 48% on chemotherapy. Ibrutinib is a type of drug known as a cancer growth blocker. It works by stopping signals that cancer cells use to divide and grow. And venetoclax blocks the functions of a protein found in CLL cells. Experts said that the new treatment regime was also tolerated better than traditional treatments. Dr Talha Munir, consultant haematologist at Leeds Teaching Hospitals NHS Trust, who led the study said: 'Flair trial is a milestone. 'We have shown that a chemotherapy-free approach can be not only more effective but also more tolerable for patients. 'By tailoring individualised treatment based on how well the cancer responds, we're moving into an era of truly personalised medicine.' Catherine Whitfield, 63, from Farnley, West Yorkshire, was diagnosed with CLL in 2018 after she noticed symptoms including bleeding gums, constant illness and neck pain. She signed up to the trial, which was co-ordinated by the Leeds Cancer Research UK Clinical Trials Unit at the University of Leeds and sponsored by the University of Leeds. She said: 'After three years of treatment, I am still MRD negative – that means no cancer cells.' 'I lost my husband to cancer. I have seen how hard it could be. 'My first thought after my diagnosis was, I will never see my grandchildren being born and growing up. 'Now I have two grandchildren, Drew and Alaia, and they are a delight and highlight the joys of a healthy life'. Ms Whitfield added: 'The way this trial was explained, it just made sense. 'Also, the thought of chemotherapy was scary to me. The trial felt right. And it was.' Dr Iain Foulkes, executive director of research and innovation at Cancer Research UK, which funded the trial along with AbbVie, and Johnson and Johnson, said: 'The results of the Flair trial show that we can provide kinder, more targeted treatment for chronic lymphocytic leukaemia, which gives people with CLL more precious time with their loved ones. 'We're hopeful that the results of the Flair trial will power new treatment options for leukaemia and other blood cancers, thanks to the efforts of researchers at in Leeds and across the UK working together on this trial.' Chronic lymphocytic leukaemia is the most common form of leukaemia in adults. There are about 4,000 new CLL cases in the UK every year.
Medscape
6 days ago
- Health
- Medscape
MRD: A Shared Compass for Patients, Clinicians, and Regulators
MILAN — The landscape of hematologic malignancies is shifting rapidly, in part due to the evolving significance of measurable (formerly "minimal") residual disease (MRD). Once confined to the realm of research, MRD is emerging as a critical tool for clinical and regulatory decision-making. In conditions such as acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and multiple myeloma (MM), MRD has become more than a marker of extent of disease burden; it now informs prognosis, therapeutic response, and access to novel treatments. "MRD is not a new concept; it has been studied for years", Jesus San Miguel Izquierdo, MD, PhD, director of clinical and translational medicine at the University of Navarra, Pamplona, Spain, told Medscape Medical News . Thanks to technological advances, unprecedented sensitivity in detecting residual cancer cells following treatment, in other words MRD, has been achieved. "We are capable of identifying a single tumor cell among a million," said San Miguel Izquierdo, who was awarded the 2025 EHA Lifetime Achievement Award for his lifelong work in MM. At a multidisciplinary session here at the European Hematology Association (EHA) 2025 Annual Meeting in Milan, representatives of patient organizations, clinicians, and regulatory bodies offered insights into the expanding role of MRD. Although its utility as an indicator of treatment response is widely recognized, debates remain over standardization, regulatory implications, and its intersection with patient experience and access. The Patient Voice: MRD as a Tool of Hope and Anxiety Anne-Pierre Pickaert, a survivor of ALL and patient advocate, described MRD in profoundly personal terms. For many patients, MRD is both a beacon and a burden. "It's like a needle in a haystack," she explained, noting that the absence of detectable cancer cells does not always equate to the absence of disease, and that uncertainty can be emotionally taxing. The terminology shift from "minimal" to "measurable" residual disease may have technical sense, but it can be unsettling for patients. "Minimal" is often interpreted as benign or reassuring, whereas "measurable" conveys clinical precision but may also amplify anxiety. Conversely, "minimal" can offer false reassurance, underestimating actual risk. There are also disparities in how MRD is communicated and understood across different hematologic diseases. For patients with ALL or AML, MRD status can dictate eligibility for transplants, trials, or access to novel therapies. In contrast, patients with chronic lymphocytic leukemia or lymphoma may be less familiar with the concept, reflecting its inconsistent use in routine care. Advocacy networks face challenges in delivering cohesive education across this diverse landscape. Pickaert also used the term "MRD-xiety," likening it to the "scanxiety" experienced by patients with solid tumors awaiting imaging results. As MRD often determines treatment direction, it carries substantial emotional weight. Yet most patients remain unaware of the regulatory frameworks that shape access to MRD-guided interventions. "We just want access," she said, be it through compassionate use, early access programs, or full reimbursement. Clinician Perspective: A Shift in Therapeutic Strategy Nicola Gökbuget, MD, head of the study center, department of hematology/oncology, University Cancer Center, Frankfurt, Germany, highlighted how MRD is transforming clinical strategy. Presenting an ALL case, she emphasized the paradigm shift from hematologic to molecular decision-making. "Historically, we acted on clinical relapse. Today, persistent or re-emerging MRD — as a molecular failure — can prompt therapeutic changes." This proactive model is influencing clinical trial designs and enabling more personalized approaches, such as targeting residual disease before transplant. In contrast, classical strategies relied on hematologic response and salvage therapy after hematologic progression. Still, the clinical utility of MRD depends on standardization. Clinicians need consensus definitions for response categories — complete molecular remission, intermediate response, molecular failure — as well as harmonized testing modalities and timepoints. Gökbuget stressed that the value of MRD risks being undermined without unified standards. Coordinated efforts from academic groups and industry partners will be essential. The Regulatory View: Is Surrogacy the Right Goal? Pierre Démolis, MD, PhD, chair of the Oncology Working Party and co-chair of the Scientific Advice Working Party at the European Medicines Agency, discussed the nuanced regulatory stance on MRD. Although MRD is a powerful indicator of response, it is not yet a validated surrogate endpoint. Surrogacy, in regulatory terms, requires consistent, reproducible correlation with overall survival across various contexts; something MRD has not fully achieved. Still, Démolis advocates for MRD as a "response trigger" in adaptive designs, transplant decisions, and early treatment assessments. "Let's stop pretending surrogacy is required to make MRD useful," he said. "It's like objective response rate or complete hematologic response; we've used such endpoints for decades." He clarified the distinction between activity and efficacy: activity refers to pharmacodynamic effects (eg, tumor shrinkage, MRD negativity), while efficacy denotes clinical benefit (eg, overall survival, progression-free survival). Activity-based endpoints such as MRD are already used in single-arm trials, particularly when randomized data are impractical. However, MRD should not replace overall survival as the final endpoint. "It can be used in conditional settings, provided final efficacy outcomes confirm its relevance," he added. Survey Shows Divergence in Attitudes Anna Smit, a PhD candidate at Erasmus MC Cancer Institute in Rotterdam, the Netherlands, presented preliminary findings from a joint EHA-International Myeloma Society survey on the role of MRD in MM trials. Among 389 healthcare professionals and 40 regulators surveyed, most supported MRD negativity as a primary endpoint, regardless of transplant eligibility. Nearly all respondents emphasized the need for global standardization. Yet variation in techniques and sensitivities remains a major barrier. Smit noted that in April 2024, the Oncologic Drugs Advisory Committee of the US Food and Drug Administration unanimously supported MRD-negative complete response as an endpoint to justify accelerated approval in MM. Europe, however, has not yet agreed to this and continues to monitor the field. Démolis confirmed ongoing global regulatory discussions on different topics, including MRD, highlighting monthly exchanges among agencies to share and possibly align perspectives. Patient-Centered Medicine Remains Paramount Quality of life (QoL) was also discussed during the session as another important aspect of the patient-centered approach to hematologic malignancies. For Pickaert, QoL is a non-negotiable endpoint: "Patients want survival, but not at any cost." Démolis echoed this view: "If you prolong life by a month but destroy QoL, is that meaningful?" Gökbuget acknowledged the practical difficulties of collecting QoL data, especially in acutely ill populations, but emphasized that such hurdles are not insurmountable. "Even when patients are unwell, someone can help complete the questionnaire," Pickaert said. Integrating QoL into MRD-based strategies could ensure that treatments extend not just life but also well-being. "As regulators, we must prioritize QoL in our decisions," Démolis said. San Miguel Izquierdo reinforced this message in a comment to Medscape Medical News . "Looking at MRD allows for early intervention," he said, implicitly linking early intervention to better QoL. Although some clinicians worry about overtreatment, the risk of undertreatment is often far greater. "By ignoring MRD, we risk undertreating 90% of patients and overtreating 10%," he concluded. Pickaert, Smit, and Démolis have reported no relevant financial relationships. Gökbuget has reported advisory board participation for and speaker honoraria and travel support from Amgen, AstraZeneca, Autolus, Celgene, Clinigen, Gilead, Incyte, Jazz Pharmaceuticals, Novartis, Pfizer, Sanofi, and Servier; and institutional research support from Amgen, Clinigen, Incyte, Jazz Pharmaceuticals, Novartis, and Servier. San Miguel Izquierdo has declared participation on advisory boards and consulting services, on behalf of his institution, for AbbVie, Amgen, BMS, Celgene, GSK, Haemalogix, Janssen-Cilag, Karyopharm, MSD, Novartis, Pfizer, Takeda, Regeneron, Roche, Sanofi, Secura Bio, and Gilead-Kite.
Scoop
07-06-2025
- Business
- Scoop
HKH Constituency Submits 2024 CDF Expenditure Report, Reinforces Accountability & Compliance With CDF Act 2023
Press Release – Solomon Islands Ministry of Rural Development The report submitted comprised of the records of the total CDF allocation of about 3.88m disbursed to each constituency at the end of the Financial Year 2024. The Hograno-Kia-Havulei Constituency (HKHC) on Monday this week submitted its 2024 CDF Expenditure Report to the Ministry of Rural Development (MRD), reinforcing accountability and compliance with the reporting obligation under Section 29 of the CDF Act 2023. The report submitted comprised of the records of the total CDF allocation of about 3.88m disbursed to each constituency at the end of the Financial Year 2024. The presentation was done by the Constituency Development Officer for HKH Constituency, Mr Apollos Manegere on behalf of the Member of Parliament for the Constituency, Honourable Jeremiah Manele. Receiving the report on behalf of the Ministry of Rural Development, PS John Misite'e, said that this is a reassuring pace, as the Ministry continues to implement the CDF legislation and bringing guidance in the administration of the constituency program under this legal framework. PS Misite'e emphasised that Annual Reports inclusive of the financial expenditures' reports are important processes and documents within any organisation and more so when public resources are being utilised in service delivery. These reports re-enforce transparency and demonstrated accountability in the use of public resources and funds. PS Misite'e thanked the HKH constituency for its diligent efforts in complying with the reporting obligations and also thanked other constituencies that already made their submissions on this 2024 CDF disbursement. PS Misitee reiterated calls on other constituencies who are yet to submit their reports to do so as soon as possible. By law all constituency annual reports and expenditure reports should be submitted by February each year and to be compiled by MRD by March of any financial year. 'I am now calling on these constituencies to come forward with their reports soon'. PS Misite'e reiterated. The HKH Constituency Development Officer (CDO), Manegere on behalf of the Honourable Member of Parliament, Jeremiah Manele and its Constituency Officers was very delighted with its office for submitting their report and pledge to support MRD in the process annually to satisfy the legal requirements for reporting. The CDF Act 2023 was passed by Parliament on 22nd December 2023 and came into commencement/enforcement on the 5th of January 2024. This means that whatever offence (s) committed by a recipient (s) of the CDF program after the commencement date of the new Act will be subject to penalties. Penalties apply to constituents, Members of Parliament (MPs), and Public Officers if they commit an offence (s). A Member of Parliament (MP), or a Public officer or a fund (CDF) recipient commits an offence if he or she: Misappropriates any funds or assets from the fund; or Advances materials and cash from a supplier without prior approval from the responsible ministry; or Fraudulently converts project assets or materials to his own use or to the use of some other person; or Deliberately victimises non-voters by excluding them from receiving Constituency Development Funds projects and funds without justifiable grounds; or Assists or causes a person to misappropriate or apply the funds otherwise than in the manner provided in this Act and Regulations. Now that we have a new CDF Act, the responsibility is on all of us to take responsibility and comply with the new CDF law to avoid legal penalties. We (constituents) should not be fearful of this legislation as it is there to act as a guide to our conduct in working with and applying the CDF in our development processes. The purposes of the new CDF Act 2023 are;
Scoop
07-06-2025
- Business
- Scoop
HKH Constituency Submits 2024 CDF Expenditure Report, Reinforces Accountability & Compliance With CDF Act 2023
The Hograno-Kia-Havulei Constituency (HKHC) on Monday this week submitted its 2024 CDF Expenditure Report to the Ministry of Rural Development (MRD), reinforcing accountability and compliance with the reporting obligation under Section 29 of the CDF Act 2023. The report submitted comprised of the records of the total CDF allocation of about 3.88m disbursed to each constituency at the end of the Financial Year 2024. The presentation was done by the Constituency Development Officer for HKH Constituency, Mr Apollos Manegere on behalf of the Member of Parliament for the Constituency, Honourable Jeremiah Manele. Receiving the report on behalf of the Ministry of Rural Development, PS John Misite'e, said that this is a reassuring pace, as the Ministry continues to implement the CDF legislation and bringing guidance in the administration of the constituency program under this legal framework. PS Misite'e emphasised that Annual Reports inclusive of the financial expenditures' reports are important processes and documents within any organisation and more so when public resources are being utilised in service delivery. These reports re-enforce transparency and demonstrated accountability in the use of public resources and funds. PS Misite'e thanked the HKH constituency for its diligent efforts in complying with the reporting obligations and also thanked other constituencies that already made their submissions on this 2024 CDF disbursement. PS Misitee reiterated calls on other constituencies who are yet to submit their reports to do so as soon as possible. By law all constituency annual reports and expenditure reports should be submitted by February each year and to be compiled by MRD by March of any financial year. 'I am now calling on these constituencies to come forward with their reports soon'. PS Misite'e reiterated. The HKH Constituency Development Officer (CDO), Manegere on behalf of the Honourable Member of Parliament, Jeremiah Manele and its Constituency Officers was very delighted with its office for submitting their report and pledge to support MRD in the process annually to satisfy the legal requirements for reporting. The CDF Act 2023 was passed by Parliament on 22nd December 2023 and came into commencement/enforcement on the 5th of January 2024. This means that whatever offence (s) committed by a recipient (s) of the CDF program after the commencement date of the new Act will be subject to penalties. Penalties apply to constituents, Members of Parliament (MPs), and Public Officers if they commit an offence (s). A Member of Parliament (MP), or a Public officer or a fund (CDF) recipient commits an offence if he or she: Misappropriates any funds or assets from the fund; or Advances materials and cash from a supplier without prior approval from the responsible ministry; or Fraudulently converts project assets or materials to his own use or to the use of some other person; or Deliberately victimises non-voters by excluding them from receiving Constituency Development Funds projects and funds without justifiable grounds; or Assists or causes a person to misappropriate or apply the funds otherwise than in the manner provided in this Act and Regulations. Now that we have a new CDF Act, the responsibility is on all of us to take responsibility and comply with the new CDF law to avoid legal penalties. We (constituents) should not be fearful of this legislation as it is there to act as a guide to our conduct in working with and applying the CDF in our development processes. The purposes of the new CDF Act 2023 are;
