Immunohistochemistry

CAP Updates Validation of Immunohistochemical Assays Testing Guideline for Precise Results, Improved Patient Care

Retrieved on: 
Friday, February 23, 2024

The College of American Pathologists (CAP) updated the “Principles of Analytic Validation of Immunohistochemical Assays” guideline to provide increased precision and accuracy of clinical immunohistochemical assays.

Key Points: 
  • The College of American Pathologists (CAP) updated the “Principles of Analytic Validation of Immunohistochemical Assays” guideline to provide increased precision and accuracy of clinical immunohistochemical assays.
  • This update assesses evidence published since the release of the original guideline in 2014 and provides new recommendations on how to analytically validate/verify immunohistochemical assays used for diagnostic and predictive purposes.
  • “This updated guideline provides new and revised recommendations for analytic validation/verification of immunohistochemical assays, which often guide therapeutic decision making for cancer treatment,” explains guideline chair, Jeffrey D. Goldsmith, MD, FCAP.
  • Current tools, resources, and information for the Principles of Analytic Validation of Immunohistochemical Assays: Guideline Update can be found on the guideline webpage on cap.org.

Western Blotting Market on the Rise, Expected to Hit $2.1 Billion by 2028: Strategic Analysis by BCC Research

Retrieved on: 
Wednesday, February 7, 2024

BOSTON, Feb. 7, 2024 /PRNewswire/ -- Diving into the world of scientific discovery, Western Blotting is like a superhero in the lab, helping researchers unravel the mysteries of proteins in complex mixtures. Picture it as a 'molecular fingerprint' that lets scientists sleuth around, uncovering the who, what, and how many proteins. This technique isn't just a fancy lab trick – it's a powerhouse in understanding diseases, crafting new drugs, and decoding the intricate dance of biological processes. With its fingerprints all over biology, medicine, and biotech, Western Blotting isn't just a tool; it's a key player in the game of life sciences, offering researchers a versatile way to unlock groundbreaking molecular insights.

Key Points: 
  • Embark on a comprehensive journey into the dynamic realm of Western Blotting with our latest report.
  • The journey through time has witnessed transformative modifications, with innovations like multiplex Western Blotting and quantitative techniques enriching its capabilities.
  • Increasing Prevalence of Target Diseases: One of the primary driving forces propelling the Western Blotting market is the escalating prevalence of target diseases.
  • This synergy between government funding and Western Blotting underscores the critical role this method plays in shaping the landscape of biomedical research.

Sai Life Sciences augments DMPK capabilities to ace large-scale collaborations

Retrieved on: 
Thursday, February 1, 2024

HYDERABAD, India, Feb. 01, 2024 (GLOBE NEWSWIRE) -- To offer global big pharma clients cutting-edge, end-to-end drug metabolism and pharmacokinetics (DMPK) services, Sai Life Sciences, a global Contract Research, Development & Manufacturing Organization (CRO-CDMO) , has expanded its DMPK capabilities .

Key Points: 
  • HYDERABAD, India, Feb. 01, 2024 (GLOBE NEWSWIRE) -- To offer global big pharma clients cutting-edge, end-to-end drug metabolism and pharmacokinetics (DMPK) services, Sai Life Sciences, a global Contract Research, Development & Manufacturing Organization (CRO-CDMO) , has expanded its DMPK capabilities .
  • Making the announcement, Krishna Kanumuri, CEO & Managing Director, Sai Life Sciences, said, “The focus of innovator companies on diversifying their supply chains bodes well for Indian CROs-CDMOs like ours.
  • Sauri Gudlavalleti, Chief Operating Officer said, “The latest expansion of DMPK capabilities augments our integrated drug discovery (IDD) offerings.
  • Sai Life Sciences also has plans to invest in niche areas such as peptides, oligos and large molecules to strengthen its discovery capabilities.

ENHERTU® Granted Priority Review in the U.S. for Patients with Metastatic HER2 Positive Solid Tumors

Retrieved on: 
Monday, January 29, 2024

ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Key Points: 
  • ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
  • The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in August 2023 for ENHERTU in metastatic HER2 positive solid tumors.
  • Data from other supporting trials in patients with HER2 positive IHC 3+ tumors in the ENHERTU clinical development program, including DESTINY-Lung01 and DESTINY-CRC02 , also were included in the submission.
  • We will continue working closely with the FDA to bring this potential first tumor agnostic HER2 targeted medicine to patients as quickly as possible.”

GC Cell's Promising AB-201 Cancer Treatment to Begin Phase 1 Trials Using Lunit AI Platform

Retrieved on: 
Monday, January 8, 2024

YONGIN, South Korea and SYDNEY, Jan. 8, 2024 /PRNewswire/ -- GC Cell, a fully integrated cell therapy pioneer, is proud to announce the approval from both the Australian Human Research Ethics Committee (HREC) and the Korean Ministry of Food and Drug Safety (MFDS) for a Phase 1 Investigational New Drug (IND) trial for its AB-201 cancer treatment, a HER2 targeted chimeric antigen receptor-natural killer (CAR-NK) cell therapy that shows great promise. Additionally, GC Cell is excited to reveal a strategic partnership with Lunit, the medical AI leader, to enhance precision and clinical intelligence of AB-201's efficacy evaluation by applying its advanced AI technology, in addition to traditional Immunohistochemistry (IHC) based assessments. After participating in the US White House's Cancer Moonshot initiative this past October, both accomplishments represent major milestones in GC Cell's efforts to revolutionize immunotherapy-based cancer treatment while harnessing AI and digital transformation to fight cancer.

Key Points: 
  • After participating in the US White House's Cancer Moonshot initiative this past October, both accomplishments represent major milestones in GC Cell's efforts to revolutionize immunotherapy-based cancer treatment while harnessing AI and digital transformation to fight cancer.
  • "Our preclinical studies suggest the possibility that AB-201 causes complete cancer remission and tumor suppression," remarked James Park, CEO of GC Cell.
  • With such quantitative analysis, AI can help standardize the assessment of cancer target expression across different laboratories and geographical locations.
  • It's a pivotal step in GC Cell's journey towards a digital future, aligning with the broader healthcare industry's shift towards technology-enhanced solutions.

Biocare Medical and Molecular Instruments Partner to Revolutionize Automated Bioimaging Through ONCORE Pro X and HCR™ RNA-ISH Assays

Retrieved on: 
Friday, January 5, 2024

Molecular Instruments®: Inventor of the HCR™ Platform: Molecular Instruments®, the market disruptor in bioimaging and ISH reagents, brings to the table their patented HCR™ Imaging technology.

Key Points: 
  • Molecular Instruments®: Inventor of the HCR™ Platform: Molecular Instruments®, the market disruptor in bioimaging and ISH reagents, brings to the table their patented HCR™ Imaging technology.
  • Biocare Medical's ONCORE Pro X: A Paradigm in Automation: Recognized as a leader in automated instrumentation, Biocare Medical's ONCORE Pro X exemplifies innovation and versatility.
  • Synergizing Strengths for Advanced Bioimaging: The integration of MI's HCR™ Platform into Biocare Medical's ONCORE Pro X instrument represents a synergy of strengths.
  • A New Era in Bioimaging: By integrating Biocare Medical's advanced automated instrumentation with the revolutionary HCR™ Platform from Molecular Instruments, researchers can now harness the power of the ONCORE Pro.

Data Presented at SABCS Demonstrate the Significant Promise of Precede Biosciences’ Novel Liquid Biopsy Platform to Define HER2 and ER Status in Patients With Advanced Breast Cancer

Retrieved on: 
Wednesday, December 6, 2023

The data demonstrate the ability of the platform to reveal disease-defining transcriptional biology of metastatic breast cancer and to accurately classify patients as HER2 3+ vs. HER2 0 and ER+ vs. ER- from just 1mL of plasma.

Key Points: 
  • The data demonstrate the ability of the platform to reveal disease-defining transcriptional biology of metastatic breast cancer and to accurately classify patients as HER2 3+ vs. HER2 0 and ER+ vs. ER- from just 1mL of plasma.
  • “Determination of HER2 and ER status is foundational to therapeutic decision-making in patients with advanced breast cancer,” said Heather A. Parsons, MD, MPH, Dana-Farber Cancer Institute, lead author.
  • All patients had plasma drawn within six weeks of a tissue biopsy that was assessed for HER2 and ER by immunohistochemistry.
  • Breast cancer cell lines were profiled to enable initial feature selection for the HER2 and ER classifiers.

Coherus Presents Phase 1/2 Clinical Data on Casdozokitug, a First-in-Class IL-27-Targeted Antibody, at the 2023 ESMO Immuno-Oncology Congress

Retrieved on: 
Wednesday, December 6, 2023

REDWOOD CITY, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced data from the ongoing Phase 1b/2 clinical trial of casdozokitug (casdozo), a first-in-class IL-27-targeting antibody, being presented at the 2023 ESMO Immuno-Oncology Congress taking place December 6 – 8, 2023 at Palexpo Exhibition Centre in Geneva, Switzerland. The presentation includes updated data for casdozo monotherapy dose escalation and expansion cohorts and a cohort evaluating treatment with casdozo in combination with the anti-PD-1 antibody pembrolizumab (pembro) in patients with non-small cell lung cancer (NSCLC) who have progressed after 2-4 prior lines of therapy, including chemotherapy and anti-PD-1 agents. Interleukin (IL)-27 is an immunoregulatory cytokine involved in suppressing anti-tumor immune responses and an important new target for cancer treatment. Casdozo is a first-in-class antibody, and the only clinical stage immunomodulatory cytokine antagonist targeting IL-27.

Key Points: 
  • Interleukin (IL)-27 is an immunoregulatory cytokine involved in suppressing anti-tumor immune responses and an important new target for cancer treatment.
  • Casdozo is a first-in-class antibody, and the only clinical stage immunomodulatory cytokine antagonist targeting IL-27.
  • The overall response rate (ORR) in the subset of patients with squamous NSCLC (n=2/9) was 22% in this data cut.
  • Casdozo continues to demonstrate an acceptable safety profile as monotherapy or in combination with a PD-1 inhibitor (pembro).

MediciNova Announces New Data and Results of a Phase 2 Clinical Trial of MN-166 (ibudilast) in Glioblastoma Presented at the 28th Annual Meeting of the Society for Neuro-Oncology

Retrieved on: 
Sunday, November 19, 2023

The presentation also included data from preclinical studies which evaluated the combination of MN-166 (ibudilast) and anti-PD1 or anti-PD-L1 therapy in GBM models.

Key Points: 
  • The presentation also included data from preclinical studies which evaluated the combination of MN-166 (ibudilast) and anti-PD1 or anti-PD-L1 therapy in GBM models.
  • MN-166 (ibudilast) and TMZ combination treatment was safe and well-tolerated, and no unexpected adverse effects were reported.
  • We are eager to evaluate MN-166 (ibudilast) in combination with anti-PD1 and anti-PD-L1 therapies in a future clinical trial.
  • MediciNova is grateful to the patients and families for their invaluable participation in our trial.”

Biocare Medical Unveils intelliPATH+: Next-Generation Enhancement of the Proven intelliPATH FLX Staining System

Retrieved on: 
Tuesday, December 5, 2023

SAN FRANCISCO, Dec. 5, 2023 /PRNewswire/ -- Biocare Medical, a leader in immunohistochemistry (IHC) and in situ hybridization (ISH) diagnostics, is proud to introduce the intelliPATH+ Advanced Staining Instrument.

Key Points: 
  • SAN FRANCISCO, Dec. 5, 2023 /PRNewswire/ -- Biocare Medical, a leader in immunohistochemistry (IHC) and in situ hybridization (ISH) diagnostics, is proud to introduce the intelliPATH+ Advanced Staining Instrument.
  • The intelliPATH+ has been meticulously redesigned with input from users and the latest technological advancements to become a fully open system that accommodates continuous random access with immediate STAT capabilities.
  • It offers a seamless workflow with increased speed and superior quality in IHC staining, all while reducing waste.
  • The intelliPATH+ system takes command of every analytical detail in the staining process.