Before you start the selection process, it’s essential to clearly understand your project's specific needs and long-term goals. Think about the therapeutic area, the biomarkers involved, regulatory requirements across different regions, and the timelines for drug and diagnostic development.

A partner that closely aligns with your objectives and has a proven track record in similar projects will be invaluable.

Evaluate technical expertise and capacity of your CDx partner

When evaluating potential CDx partners, their expertise and experience in the field should be your top priority. The right CDx partner should have the technical expertise to develop and validate the diagnostic, as well as the capacity to manage the scale of your project. This includes having the right technological platforms in all relevant markets, quality systems, and manufacturing capabilities. Experience in navigating the regulatory landscape for CDx approvals is equally important, as this can significantly impact your drug’s time to market.

Consider the regulatory and market access strategy

Navigating the complex landscape of regulatory approvals is a significant challenge in CDx development. Choose a partner with a solid regulatory strategy and a proven record of successful CDx submissions. If they understand the market access landscape and are able to navigate it, it can further enhance the CDx value for your therapeutic product.

Developing a CDx requires close collaboration between the pharma company and its CDx partner. A partner whose corporate culture aligns with yours and who values open, transparent communication can make this relationship much easier.

Regular updates, mutual problem-solving, and a shared commitment to the project's success are key facets of a strong partnership.

Look beyond development to commercialization

The journey of a CDx doesn’t end with its development and regulatory approval. Effective commercialization is crucial to ensure that the diagnostic reaches its target audience and is adopted by healthcare providers.

To maximize the impact of your CDx, choose a partner with a global reach, experience in market access strategies, and a strong distribution network.

Diaceutics: your partner in navigating the CDx landscape

At Diaceutics, we understand the complexities involved in bringing a targeted therapy to market. Our expertise in precision medicine, combined with our global network and data-driven approach, uniquely positions us to assist pharma in selecting the right CDx partner. Not only can we help you develop an effective CDx strategy, but we can also provide insights into market dynamics, regulatory pathways, and commercialization strategies to ensure your therapy and its companion diagnostic achieve their full potential.

Choosing the right CDx partner is essential for the success of your targeted therapy. By considering these critical points and leveraging the expertise of a seasoned partner like Diaceutics, you can navigate this journey with confidence.

In the quest to bring more personalized treatment options to patients, the right collaborations can make all the difference. Reach out to Diaceutics today, and let’s discuss how we can support your CDx strategy and help you select the ideal partner to bring your targeted therapy to those who need it most.

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Developing a companion diagnostic (CDx) is a vital step for pharma looking to launch targeted therapies. These diagnostics help not only identify patients most likely to benefit from a specific drug but also boost drug efficacy and patient safety. However, given the complexity and regulatory intricacies involved, choosing the right CDx partner can be time consuming and difficult.

At Diaceutics, we leverage our extensive experience and deep industry insights to guide pharma companies through this critical decision. Here's how to ensure you pick the right CDx partner for your drug's go-to-market journey.

Pathogenic gene fusions as oncogenic drivers

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Can't make the live session? Register and we'll send you the recording! 

Speaker name: Kurt A. Schalper, M.D./Ph.D. 

Associate Professor of Pathology and Medicine (Medical Oncology), Yale School of Medicine. Director Translational Immuno-oncology Laboratory, Yale Cancer Center

Dr. Schalper trained as cell/molecular biologist and surgical pathologist. His professional experience includes clinical molecular diagnostics and development of cancer biomarkers. His laboratory focuses on understanding the interaction between molecular oncogenic pathways and immune evasion, and deciphering the structural/functional determinants of the tumor microenvironment in solid tumors. Dr. Schalper is also the director of the Translational Immuno-oncology Laboratory at the Yale Cancer Center where he leads the standardized analysis of biomarkers in clinical trials using advanced cell/tissue analysis platforms.

Our latest Lab Talk with Dr. Kurt Schalper explores pathogenic gene fusions as oncogenic drivers and actionable biomarkers in precision oncology, focusing on NRG1 fusions.

NRG1 is a pathogenic fusion receiving increasing attention, as it is associated with multiple poor prognostic factors

 NRG1 fusions are genetic alterations that involve the NRG1 gene being abnormally fused with another gene. These fusions are heterogeneous and have many different gene partners and breakpoints. NRG1 fusions result in increased cell signaling and growth and can lead to uncontrolled growth and cancer.

NRG1 fusions have been identified across many tumor types and generally occur in the absence of other driver mutations. The overall frequency of NRG1 fusions varies across tumor types, with the highest being found in lung cancer (0.3%-1.7%) and pancreatic cancer (0.5%-1.8%), with other tumor types having <1%.

Importantly, there is a significant enrichment in NRG1 fusions in invasive mucinous lung adenocarcinoma (27%-31%) and in KRAS wild-type pancreatic cancer (up to 6%).

Methods like RT-PCR, FISH, and IHC may fall short of detecting pathogenic gene fusions and have limitations in screening NRG1 fusions. Detection of NRG1 fusions poses challenges, as DNA-based NGS alone can miss pathogenic gene fusions and lead to false-negative and false-positive results. Comprehensive testing with RNA-based NGS, including both DNA and RNA sequencing, is recommended to capture these fusions that DNA-based NGS might miss. The detection of NRG1 fusions is particularly difficult without RNA-based NGS due to the diversity of gene fusion partners, varying breakpoints, and large intronic regions.

To learn more about NRG1 fusions and RNA-based testing please visit

Next week we will be inviting you to join our latest Lab Talk with Dr. Kurt Shalper from Yale School of Medicine. During this session Dr. Shalper will discuss pathogenic gene fusions as oncogenic drivers and actionable biomarkers in precision oncology, focusing on NRG1 fusions.

1. Gao Qet al. Cell Rep. 2018;23(1):227-238.e3. doi:10.1016/j.celrep.2018.03.050. 2. Latyshevaet al.Nucleic Acids Res. 2016;44(10):4487-4503. doi:10.1093/nar/gkw282. 3. Heyer EEet al. Nat Commun. 2019;10(1):1388. doi:10.1038/s41467-019-09374-9. 4. Liu SV. Future Oncol. 2022;18(26):2865-2870. doi:10.2217/fon-2022-0073. 5. Drilon Aet al. J Clin Oncol. 2021;39(25):2791-2802. doi:10.1200/JCO.20.03307. 6. Rosas D et al. Cancers (Basel). 2021;13(20):5038. doi:10.3390/cancers13205038. 7. Laskin J et al. Ann Oncol. 2020;31(12):1693-1703. doi:10.1016/j.annonc.2020.08.2335. 8. Zhang C et al. BiochimBiophys Acta Rev Cancer. 2022;1877(3):188707. doi:10.1016/j.bbcan.2022.188707. 9. Drilon A et al. J Clin Oncol. 2021;39(25):2791-2802. doi:10.1200/JCO.20.03307. 10. Schram AM et al. Cancer Discov. 2022;12(5):1233-1247. doi:10.1158/2159-8290.CD-21-1119. 11. Geuijen CAW et al. Cancer Cell. 2018;33(5):922-936. doi:10.1016/j.ccell.2018.04.003. 12. Liu SV. Plain language summary of NRG1 fusions in cancer: current knowledge and treatment with afatinib and other drugs. Future Oncol. 2022;18(26):2865-2870. doi:10.2217/fon-2022-0073. 13. Drilon A, Somwar R, Mangatt BP, et al. Response to ERBB3-directed targeted therapy in NRG1-rearranged cancers. Cancer Discov. 2018;8(6):686-695. doi:10.1158/2159-8290.CD-17-1004. 14. Jones MR et al. Clin Cancer Res. 2019;25(15):4674-4681. doi:10.1158/1078-0432.CCR-19-0191. 15. Liu SV et al. Future Oncol. 2022;18(26):2865-2870. doi:10.2217/fon-2022-0073. 16. Drilon A et al. Cancer Discov. 2018;8(6):686-695. doi:10.1158/2159-8290.CD-17-1004. 17. Jones MR et al. Clin Cancer Res. 2019;25(15):4674-4681. doi:10.1158/1078-0432.CCR-19-0191. 18. Bruno R et al. Diagnostics (Basel). 2020;10(8):521. doi:10.3390/diagnostics10080521. 19. Su D et al. J Exp Clin Cancer Res. 2017;36(1):121. doi:10.1186/s13046-017-0591-4. 20. Benayed R et al. Clin Cancer Res. 2019;25(15):4712-4722. doi:10.1158/1078-0432.CCR-19-0225. 21. Heydt C et al. BMC Med Genomics. 2021;14(1):62. doi:10.1186/s12920-021-00909-y

Fusions can occur across different tumor types, being a contributing factor in 1 in 6 cancers and accountable for approximately 20% of cancer morbidity. Among 9624 patients who had their tumors genetically tested with RNA-based sequencing, pathogenic gene fusions were found in 16.5% of samples.

Listen now!

Episode 5 in the ‘Better Testing, Better Treatment’ podcast series, focuses on the practical considerations for oncogenic fusion detection and reporting. In this podcast, our guests discuss the factors that go into deciding to test for oncogenic fusions, using IHC as a screening tool, and more!

We’re happy to welcome our guests Dr. James Solomon, Assistant Professor of Pathology and Laboratory Medicine at Weill Cornell Medicine and Assistant Attending Physician at the New York Presbyterian Hospital and Dr. Ashish Saxena is an Assistant Professor of Medicine at Weill Cornell Medical College and Assistant Attending Physician at the New York-Presbyterian Hospital.

Other episodes in the series are available to listen now.

We are excited to announce that our fifth episode is available now.

The recent development of radioligand therapy (RLT) has provided the therapeutic upgrade that medicine was hoping for. RLT is a form of precision nuclear medicine. Administered as intravenous infusion, it delivers radioactive particles and their detrimental effects directly to tumor sites by binding to target molecules overexpressed on tumor cells or the tumor micro-environment (Figure 1). This limits off-target effects and enables access to tumor sites that would be difficult to irradiate externally, setting RLT apart from traditional radiation treatments.

Despite all the benefits, clinical implementation of RLT is still facing numerous challenges related to regulatory policies, awareness, and availability of the treatment, which need to be tackled in order to allow eligible patients to receive treatment.

(Radio) Theranostics refers to a personalized treatment where paired radiopharmaceuticals are used for diagnostic imaging and selective treatment of a patient. It’s utilization of radiotracers, composed of radiation particles attached to a carrier molecule which will bind specifically to its target on tumor, allows for the initial confirmation of target overexpression on tumor sites followed by RLT application. This approach facilitates 

The first two ground-breaking RLTs were Lutathera and Pluvicto for somatostatin receptor 

 respectively (3-6). Considering the unique potential of RLT to create numerous combinations of radioactive isotopes and to target molecules tailored to specific tumor types, many more RLTs are both now in development and likely to come to the market in the near future.

RLTs are already being tested in clinical trials for other 

(1,7). Novel strategies targeting PSMA for prostate cancer therapy are also in clinical trials, 

comparing beta-emitting lutetium (177Lu)-labeled RLT to alpha-emitters such as actinium (225Ac)

GRPR, EGFR-cMET, IGF-1R, FRα, NTSR1, CA9/CAIX, LAT1/2, GPC3

 etc. are also being investigated in various tumor types (7, 10, 12,13, 15, 16). Expanding beyond tumor cells, novel RLTs are 

targeting cancer-associated fibroblasts and the stromal matrix

 in tumor microenvironments (1, 2, 7, 11, 17). 

Combining RLTs with already established systemic treatments

 such as chemotherapy, immunotherapy, or agents inhibiting DNA repair like PARP inhibitors, is another emerging approach being tested with the aim to improve patients’ outcomes (1,2).

As RLTs are becoming relevant therapeutic options for a growing number of patients, the current success of approved treatments is expected to drive further development of novel targeting agents in order to improve cancer detection, patient stratification and personalized treatments.

Medical innovations, despite their clinical benefits, usually come with some challenges and this holds true for RLTs as well (1).

 is currently the name of the game, dictating access to approved treatments, clinical trials and radioisotopes. There is great variability across different countries with respect to local rules and regulations for RLT, 

so understanding the regulatory requirements at the country level and building towards uniformity is critical

. The same holds true for reimbursement frameworks.

these treatments have a short shelf-life.

 This imposes tremendous time pressure on manufacturers and clinicians to produce, transport and administer treatment within a few days. 

Ensuring a consistent supply of radioisotopes can also be challenging

Currently there is a limited number of healthcare professionals properly trained in RLT, highlighting not only a strong need for more physicians specialized in nuclear medicine, but also for multidisciplinary training programs on RLT in general. Implementation of RLTs requires procedural adjustments and 

further integration of nuclear medicine with oncology.

medical institutions will need to implement some structural adjustments

 in order to provide sufficient capacity for inpatient care, and to address additional requirements related to the equipment and storage for radioactive materials.

All these factors are currently restricting the use of the RLTs to a small number of specialized centers within a few countries.

Improving patient selection and outcomes: future perspectives. 

Currently the objective response rate (ORR) for patients receiving RLTs is approximately 40-50%(3-6). Targeted PET imaging is, at the moment, the gold standard for selecting eligible patients. It is well established for approved indications, especially PSMA-positive prostate cancer, and is further being introduced/optimized across several different biomarkers/indications.

One of the underlying reasons for the lack of consistent therapy response is heterogeneous expression of target antigens on tumor cells or acquired resistance due to loss of cell-surface target molecules under the selective pressure of toxic radiation (1). Patient response to RLT differs not only with respect to treatment efficacy, but toxicity as well, defined by administered dose of radioactivity, clinical characteristics, previous treatments and possibly genetic factors (1).

Additional (biomarker) assessments of target expression, as well as better understanding of individual genomic profiles and its impact on patient’s response to RLT might prove critical for better patient stratification and improved clinical outcomes.

Unlocking Radioligand therapy potential with Diaceutics:

Diaceutics can support and accelerate your RLT-related strategies through a number of different solutions.

Our Daily DXRX Signal can help identify patients who would be potentially eligible for RLT, especially those with rare cancers, such as gastroenteropancreatic (GEP)-NET.

When no functional imaging is possible, alternative biomarker testing approaches can be considered (18). Diaceutics can support diagnostic partner selection for the development of complementary molecular assays and the implementation of novel biomarkers into regular clinical practice.

Our experts are always happy to assist with feasibility studies, and our DXRX Data Repository has the largest global and US lab dataset, allowing us to capture a robust view of the patient journey over a wide range of indications, no matter how rare. 

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Radiotheranostics in oncology: current challenges and emerging opportunities - PMC (nih.gov)

Carrier systems of radiopharmaceuticals and the application in cancer therapy | Cell Death Discovery (nature.com)

Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors | New England Journal of Medicine (nejm.org)

Novartis Lutathera® significantly reduced risk of disease progression or death by 72% as first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors | Novartis

Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer | New England Journal of Medicine (nejm.org)

Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors | Novartis

Bicycle Therapeutics - Pipeline - Bicycle Therapeutics

Lilly to Acquire POINT Biopharma to Expand Oncology Capabilities into Next-Generation Radioligand Therapies | Eli Lilly and Company

AstraZeneca to acquire Fusion to accelerate the development of next-generation radioconjugates to treat cancer

Fusion Pipeline - Fusion Pharma - Pipeline

Bristol Myers Squibb - Bristol Myers Squibb Completes Acquisition of RayzeBio, Adding Differentiated Actinium-Based Radiopharmaceutical Platform (bms.com)

ITM Radiopharma: Research & Development (itm-radiopharma.com)

Pipeline｜PEPTIDREAM INC ペプチドリーム株式会社

Radiation therapy is one of the first non-surgical cancer treatments. It was established in the late 19th century and has remained an integral part of cancer care ever since. Although radiation has a high potency for killing tumor cells, it also causes significant damage to the surrounding healthy tissue, resulting in severe side effects.

Insights

Selecting the right CDx partner: Insights from Diaceutics

DXRX Lab Talk: NRG1 fusions testing

Pathogenic gene fusions are key actionable biomarkers in precision oncology

Oncogenic Fusion detection and reporting in NSCLC and solid tumors: from clinic to lab

Radioligand therapy: How is this transforming radiotherapy into a precision medicine treatment