On September 1, 2022 SkylineDx, a leading molecular diagnostics company, reported the commercial launch of Merlin Assay as CE-IVD distributable test kit in Europe (Press release, SkylineDx, SEP 1, 2022, View Source [SID1234618925]). Merlin Assay identifies melanoma (skin cancer) patients that have a low risk for nodal metastasis and therefore can safely forgo a sentinel lymph node biopsy (SLNB) surgery . This is an invasive surgical procedure used to determine metastatic spread of the cancer for staging purposes. In approximately 80% of surgeries, the biopsy comes back negative for metastasis, where it does not further impact the patient pathway. The test provides a more personalized insight on the metastatic propensity of the tumor, identifying patients with a low-risk tumor that could avoid the surgery [2]. The CE-IVD device is based on a well-established qPCR method that can easily run in molecular diagnostic laboratories.

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This news follows the company’s recent announcement of having obtained Medicare coverage for Merlin Assay’s counterpart in the United States, Merlin Test, serviced centrally from SkylineDx’s CAP/CLIA laboratory in San Diego (CA) [3]. The company is expanding its dermatology franchise’s geographical footprint with commercial activities in the key markets United States and Europe. Whilst Merlin Test and Merlin Assay are their first and lead products in dermatology, successive introductions of additional dermatology tests are anticipated [4].

As jointly announced in April 2021, Biocartis Group NV will act as SkylineDx’s commercial distribution partner for the European market [5].

"Launching Merlin Assay as CE-IVD marked manual kit in Europe signifies a major milestone in making our diagnostic solutions available to patients globally," comments Dharminder Chahal, CEO SkylineDx. "We are looking forward to enter this new phase of our partnership with Biocartis."

"We are very excited to start commercialization in Europe of SkylineDx’s CE-IVD marked manual kit of the Merlin Assay. In Europe we have long-standing relationships with our customer base of labs and hospitals. This very innovative Merlin Assay will now allow our customers to improve outcomes for melanoma patients," concludes Herman Verrelst, CEO Biocartis.

About Merlin Assay

Merlin Assay uses the CP-GEP model, a powerful proprietary algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes [2]. The model is able to calculate risk on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness and the patient’s age; and has been analytically and clinically validated. Further clinical research and validation studies on the predictive use of the CP-GEP model is the main focus of Merlin Study Initiative, developed under the wings of Falcon R&D Program. More information (including references) may be obtained at www.falconprogram.com. Merlin Assay’s US counterpart, Merlin Test, is commercially available and Medicare reimbursed as a Laboratory Developed Test serviced from SkylineDx’s CAP/CLIA laboratory in San Diego (CA).

On September 1, 2022 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported the appointment of Dr. Anders Neijber to the position of Chief Medical Officer, Global Medical Affairs and Clinical Development and R&D, effective September 1, 2022 (Press release, PhotoCure, SEP 1, 2022, View Source [SID1234618924]).

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Dr. Neijber is Photocure’s current VP Medical Affairs and Clinical Development and joined the company in August 2021. He brings over 25 years of substantial experience in the Uro-oncology area and successful leadership in the pharmaceutical industry. He has had global and regional leadership roles, both in the U.S. and Europe, within Clinical R&D and Medical Affairs, having worked for Pfizer, AstraZeneca, Johnson & Johnson, Allergan, Ferring, and Novartis.

Dr. Neijber is a board-certified urologist, and has held an Assistant Professor position at the Department of Clinical Pharmacology, Robert Wood Johnson Medical School, New Jersey.

"In the time that Anders has been with Photocure, he has proven his ability to apply his extensive experience and deep knowledge in the field of Urology, together with his business acumen in leading our Global Medical Affairs strategy" said Dan Schneider, President and Chief Executive Officer of Photocure. "As Photocure continues to grow and expand its global reach, Medical Affairs will have an increasingly important role in navigating the complex health-care environment. Anders will be able to provide a strategic approach beyond addressing the heightened regulatory and compliance regulations, to further build a Global Medical Affairs organization that will have a strong foundation for future scalability and capability globally."

On September 1, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, will participate in a fireside chat at the Wells Fargo 2022 Healthcare Conference on Thursday, September 8, 2022, at 2:35 p.m. ET in Boston (Press release, Nuvalent, SEP 1, 2022, View Source [SID1234618923]).

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A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.

On September 1, 2022 Ibex Medical Analytics, the leader in AI-powered cancer diagnostics, reported outstanding outcomes for the Galen Breast solution in diagnosing multiple cancer types and further expansion of its AI portfolio for breast cancer diagnosis (Press release, Ibex Medical Analytics, SEP 1, 2022, View Source [SID1234618922]). The CE-Marked AI solution is generally available as Ibex partners with laboratories, hospitals and health systems across Europe to deploy Galen Breast into their routine workflow, supporting improved quality and efficiency in the diagnosis of breast biopsies.

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Breast cancer is the most common malignant disease in women worldwide, with over two million new cases each year. As such, accurate and timely diagnosis is key to guiding treatment decisions by oncologists and improving patient survival rates.

Over the last several years, rapid advances in personalized medicine have resulted in a growing complexity of cancer diagnosis. Coupled with the increase in overall cancer incidence and a global decline in the number of pathologists, these trends have led to growing workloads imposed on pathology departments. Clearly, there is a growing need for automated solutions and decision-support tools that help pathologists detect cancer to the utmost accuracy more rapidly.

Galen is Ibex’s integrated diagnostics platform supporting pathologists in the diagnosis of breast, prostate, and gastric biopsies. Galen is the most widely deployed AI technology in pathology, and laboratories, hospitals and health systems worldwide already use it as part of their everyday practice. The combination of a skilled pathologist together with the accuracy, speed and objectivity provided by Artificial Intelligence has the potential to improve the quality of diagnosis, user experience, operational efficiency, and ultimately patient outcomes.

Galen Breast demonstrated excellent outcomes in a blinded, multi-site clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. The study evaluated the performance of pathologists who used Ibex AI for diagnosing breast biopsies and compared them to pathologists who used only a microscope across multiple types of breast cancer including invasive and in-situ carcinoma as well as rare subtypes, such as metaplastic, mucinous, and other types of breast cancer. The study results showed very high accuracy and utility of Galen Breast across multiple scanning and staining platforms, and established its potential for improving the quality of diagnosis, compared to using a microscope alone. The full study results will be presented by Judith Sandbank, MD, Director of the Pathology Institute at Maccabi Healthcare Services5 and one of the principal investigators in the study, at the European Congress of Pathology which takes place in Basel, Switzerland, between September 3-7 (Ibex presents at booth no. 1).

Previous studies on Galen Breast established its AI algorithm’s accuracy in detecting cancer, distinguishing between multiple subtypes such as ducal and lobular carcinomas, grading DCIS (ductal carcinoma in-situ) and identifying rare tumors. Moreover, the solution successfully detected clinically important cancer-related and non-cancer features, including tumor infiltrating lymphocytes, angiolymphatic invasion, microcalcifications and more1,2. Galen also enables automated pre-ordering of the breast immunohistochemistry (IHC) panel and other tests which may help shorten the turnaround time for diagnosis of cancer cases, maximizing efficiency gains for laboratories and enabling patients to start treatment earlier3. Ibex is also working to expand its technology to support improved prognosis of breast cancer, by providing automated quantification of HER2, Ki67, ER and PR receptors in immunohistochemistry stained slides as part of its product portfolio. These innovative AI algorithms are intended to assist pathologists in their diagnosis which may help further enhance diagnostic efficiency and enable more accurate and objective scoring of breast biomarkers, allowing for improved treatment decisions and patient care.

"We are impressed with the successful study outcomes and the performance of Galen Breast, that was evaluated in a diagnostic setting which is identical to how our pathologists review cases in their daily routine," said Anne Vincent-Salomon, MD, Director of Pathology at Institut Curie and one of the principal investigators in the study4. "Our team demonstrated that when pathologists use Ibex’s AI technology they achieve very high accuracy levels in diagnosing breast cancer over a broad range of subtypes, with higher quality than when using a microscope alone. With these results, and as more and more laboratories transition to digital pathology workflows, I look forward to seeing Artificial Intelligence broadly adopted in the field."

"AI is going to be a critical adjunct to diagnostic pathology going forward. Pathologists reviewing whole-slide images, in combination with an AI algorithm, will provide better diagnoses and better care than either a pathologist alone or AI alone," said Stuart Schnitt, MD, Chief of Breast Oncologic Pathology at the Dana-Farber/Brigham and Women’s Cancer Center and Professor of Pathology at Harvard Medical School4. "AI has already demonstrated its value in helping pathologists improve the quality of breast cancer diagnosis and reduce misdiagnosis, and I am impressed with the outcomes of this new study, demonstrating the robustness and utility of Ibex AI in a primary diagnosis setting. I look forward to seeing the impact this solution will have on the overall performance of pathology departments and patient outcomes, as it becomes widely adopted."

"We are excited to announce this milestone results and enable breast pathologists to further adopt AI into their routine diagnosis of breast biopsies, following excellent outcomes in a clinical study" said Chaim Linhart, PhD, Co-founder and CTO of Ibex at Ibex Medical Analytics. "We believe that AI has an essential role to play in pathology and cancer diagnosis, extending beyond cancer detection to ultimately support pathologists across most of the diagnostic pathway, as demonstrated by the scope of clinical features available with Galen Breast, as well as the expansion toward automated quantification and scoring of breast biomarkers".

On September 1, 2022 Recursion (NASDAQ: RXRX), the clinical-stage biotechnology company industrializing drug discovery by decoding biology, reported its participation in the following investor conferences (Press release, Recursion Pharmaceuticals, SEP 1, 2022, View Source [SID1234618920]):

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Morgan Stanley Global Healthcare Conference — September 12 through September 14, 2022
Goldman Sachs Global Sustainability Forum — September 29, 2022