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PRESS RELEASE 02/06/2025, 10:00 CEST Biocartis Announces IVDR Class C CDx Certification of the Idylla™ EGFR Mutation Test Mechelen, Belgium, 02 June 2025 – Biocartis NV (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ EGFR Mutation Test has received the European Union (EU) Technical Documentation Assessment and Quality Management System certificate under the European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR), making it the first Idylla™ Test to be certified as a Class C Companion Diagnostic (CDx) IVD Medical Device under the IVDR framework. The IVDR-certified Idylla™ EGFR Mutation Test is designed to serve as a CDx for the detection of EGFR exon 19 deletions and the L858R mutation, which are key biomarkers that guide targeted therapies for patients with non-small cell lung cancer (NSCLC). The IVDR certification confirms the Test’s compliance with Europe’s rigorous new regulatory standards, ensuring enhanced patient safety, improved information transparency, and robust data traceability. Designed for use on the Idylla™ Platform, the Test qualitatively detects 44 mutations across exons 18, 19, 20, and 21 of the EGFR gene – all within a single cartridge. Among these, exon 19 deletions and L858R mutations are validated as CDx targets, and the remaining mutations have been analytically validated. Utilizing formalin-fixed, paraffin-embedded (FFPE) tissue samples, the Test is fully automated from sample to result, delivering fast results in under 3 hours – streamlining laboratory workflows and empowering oncologists with timely treatment decisions for their patients. With 99.2% sensitivity (PPA) and 99.0% specificity (NPA) for the CDx targets, the Idylla™ EGFR Mutation Test ensures accurate detection of key EGFR mutations, providing healthcare professionals with actionable results to guide treatment decisions in NSCLC. For more information about the Test, please visit the Biocartis website or contact the Biocartis team. While the IVDR-certified Idylla™ EGFR Mutation Test is now available to customers across Europe, with availability in other non-US markets expected to follow progressively – Biocartis is also developing the Idylla™ EGFR CDx Test in the US with AstraZeneca. Upon approval, the Test will be intended to help identify patients with NSCLC who may respond to treatment with Tagrisso® (Osimertinib), AstraZeneca’s third-generation EGFR-TKI treatment. Roger Moody, Chief Executive Officer of Biocartis, commented: “Achieving IVDR certification for our Idylla™ EGFR Mutation Test is a key milestone for Biocartis and reinforces our commitment to quality and regulatory excellence. This is the first Idylla™ Test to be certified under the new IVDR framework, and we are currently pursuing certification of additional Tests in our portfolio. The IVDR establishes more rigorous standards to improve patient safety and diagnostic accuracy, and we are proud to be at the forefront of this evolution in European diagnostics.” ----- END ----- More information: www.biocartis.com info@biocartis.com Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium About Biocartis With its revolutionary and proprietary Idylla™ Platform, Biocartis aspires to enable personalized medicine for patients around the world through universal access to molecular testing, by making molecular testing actionable, easy, fast and suitable for any lab. The Idylla™ Platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) based system designed to offer in-house molecular biomarker testing in only 3 hours, allowing fast and optimal treatment selection. ​Idylla™'s continuously expanding menu of molecular diagnostic tests and research assays addresses key unmet clinical needs. Today, Biocartis offers tests supporting lung, skin, thyroid, colorectal, endometrial, blood, brain and breast cancer. More information: www.biocartis.com. Follow us on LinkedIn, Facebook and X (Twitter). Disclaimers Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, listed as a class II device in the US under establishment registration 3009972873, and registered in many other countries. Idylla™ EGFR Mutation Test (A0270/6) is CE-marked in Europe in compliance with the EU IVD Regulation 2017/746 (IVDR). Biocartis and Idylla™ are registered trademarks in Europe, the US and many other countries. The Biocartis and Idylla™ trademarks and logos are used trademarks owned by Biocartis NV. © June 2025, Biocartis NV. All rights reserved.

CHICAGO Funding cancer research isn't usually a political flashpoint. But as the Trump administration signals its desire to drastically cut the budget of the National Cancer Institute, the American Society of Clinical Oncology is finding itself forced to defend what is usually a bipartisan policy.“If implemented, these cuts would be devastating to the pace and progress of cancer research in America,“ ASCO CEO Clifford Hudis said in a Friday statement. ASCO maintains that federally funded cancer research is the single best investment our country has ever made.“ASCO's annual meeting this year provides a convincing example. A large study funded by the NCI found that adding the immunotherapy Tecentriq to a common chemotherapy regimen can halve the risk of disease recurrence or death in patients with a certain form of colon cancer. These data, said one of the researchers involved, will change clinical practice.But they may not have been as easily obtained without the help of the NCI, said Joel Saltzman, vice chair of regional oncology at the Cleveland Clinics Taussig Cancer Center, in a press conference held for reporters. This was a study that took five years to accrue patients to. It was open at 300 sites, he said. A study like this would just not have been feasible without the federal funding from the National Cancer Institute. Ned PagliaruloA $1 billion dollar posterOn Saturday, doctors and biotechnology executives got a closer look at Pfizers latest billion-dollar acquisition, a bispecific antibody from Chinas 3SBio, code-named SSGJ-707, that blocks the proteins PD-1 and VEGF.3SBio, which licensed Pfizers rights to SSGJ-707 for $1.25 billion upfront, presented mid-stage study data in a poster session that hinted at the drugs promise in non-small cell lung cancer. The Phase 2 study involved previously untreated people whose tumors express the protein PD-L1.Treatment shrank tumors in about two-thirds of participants given a dose of 10 milligrams infused every three weeks, with lower response rates at doses of 5, 20 and 30 milligrams. Nearly all patients experienced side effects, notably liver enzyme elevations and increased cholesterol. More than half on the 20 and 30 milligram doses had side effects judged to be severe or medically significant, while on lower doses only about 1 in 4 did.Researchers, led by Lin Wu of Hunan Cancer Hospital in China, wrote that the data support further evaluation of the 10 milligram dose. Four trials are listed as underway at clinicaltrials.gov, with a fifth planned.The 3SBio data came a day after Summit Pharmaceuticals and Akeso released Phase 3 data from their PD-1/VEGF combination treatment, now one of the most closely watched drugs in all of oncology. Jonathan GardnerAstraZenecas ad blitzWalk around Chicago this weekend and youre likely to see an ad for AstraZenecas cancer research, often emblazoned on the sides of bus stops. Take an Uber to McCormick Place, the convention center that houses ASCO for five days, and you might be reminded by an ad on the app that its been 10 years since the initial approval of Tagrisso, which now ranks among the top 20 most lucrative pharmaceutical products by sales.All pharma companies advertise at ASCO, of course, but AstraZeneca has a lot of talk about this year. For the seventh year in a row, the maker of Tagrisso, Imfinzi and Enhertu has trial data highlighted in the ASCO plenary session an occasion AstraZeneca executives are marking with a pin that weaves the number 7 between the A and Z of their companys logo.An AstraZeneca ad in downtown ChicagoNed Pagliarulo/BioPharma DiveData from one such highlighted study indicate that an AstraZeneca drug called camizestrant could be swapped in for so-called aromatase inhibitors as part of an initial treatment regimen for the most common form of advanced breast cancer. Aromatase inhibitors, one AstraZeneca bus stop ad reminds possibly confused Chicagoans, were state of the art in the 1990s. Then again, so were videotapes, it adds.Camizestrant is not yet approved, but AstraZeneca expects it will eventually become a major product. Its importance is reflected in its name: the cami root is a nod to the British drugmakers Cambridge laboratories, where camizestrant originated. Ned PagliaruloAn unexpected gene therapy spotlightHaydar Frangoul, a pediatric hematologist and oncologist, is used to presenting at medical meetings. But ASCO isnt the usual forum for Frangoul, who played a major role in testing the CRISPR gene editing treatment Casgevy for sickle cell disease.I was shocked they wanted to hear about sickle cell at ASCO, Frangoul said Saturday, opening a joint session on gene therapy held by ASCO and the American Association of Cancer Research.Frangoul walked the assembled cancer doctors and researchers through the study that supported Casgevys U.S. approval in December 2023. Jimi Olaghere, a patient in that study, described his life before treatment, and how Casgevy has changed it.Their reflections spotlighted what gene therapy can accomplish, even as the field falters amid waning investor interest, dried-up funding and persistent safety concerns.Its an important reminder even in oncology, which is perhaps not as often associated with gene therapy as rare diseases like sickle cell. Kymriah, a CAR-T cell treatment for leukemia, was the first therapy based on gene transfer technology to be cleared by the FDA. Five other CAR-Ts have been approved since, as have several other T cell-based medicines.More are likely coming, too. The session closed with a presentation from Katy Revzani, head of the MD Anderson Cancer Centers cell therapy institute, about her hospitals research exploring NK cell therapy, which she said could be safer and easier to produce off of the shelf. Ned Pagliarulo '