PGDx Cancer Assay Wins IDE to Be Used in Merck Trial

Personal Genome Diagnostics (PGDx) and Merck are looking to find the right combination to enhance and improve cancer therapy. Both companies hope to achieve this goal through an IDE FDA recently granted to Baltimore-based PGDx. The IDE gives PGDx approval for the use of its elio tissue complete assay in a Merck trial of pembrolizumab-base combination therapy. The elio assay will be used during the trial to analyze genomic markets to direct patient enrollment and stratification. PGDx’s elio tissue complete panel is a 500+ gene test for somatic alterations that detect single nucleotide variants (SNVs), small insertion/deletions, amplifications, rearrangements, microsatellite instability (MSI) and tumor mutation burden. PGDx provides genomic solutions from biomarker discovery to companion diagnostic development through its CAP/CLIA certified laboratory and is developing a portfolio of regulated tissue-based and liquid biopsy genomic products to enable local next-generation sequencing (NGS) testing in laboratories worldwide. “We’re pleased with FDA’s decision to approve PGDx’s elio tissue complete assay for this trial, as it validates the robustness of the test and reinforces the role of diagnostic biomarkers in investigating treatment strategies for patients living with cancer,” said Doug Ward, CEO at PGDx. “Further, Merck’s selection of...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Source Type: news

Related Links:

Kolch David Matallanas The RASSF1A tumour suppressor is a scaffold protein that is involved in cell signalling. Increasing evidence shows that this protein sits at the crossroad of a complex signalling network, which includes key regulators of cellular homeostasis, such as Ras, MST2/Hippo, p53, and death receptor pathways. The loss of expression of RASSF1A is one of the most common events in solid tumours and is usually caused by gene silencing through DNA methylation. Thus, re-expression of RASSF1A or therapeutic targeting of effector modules of its complex signalling network, is a promising avenue for treating seve...
Source: Cancers - Category: Cancer & Oncology Authors: Tags: Review Source Type: research
Immune checkpoint inhibitors (ICIs) have reshaped cancer therapy. ICIs enhance T cell activation through various mechanisms and may help reverse the exhausted phenotype of tumour-infiltrating lymphocytes. However, disrupting the key role that checkpoint molecules play in immune homeostasis may result in autoimmune complications. A broad range of immune-related adverse events (irAEs) involve almost every organ but mostly affect the skin, digestive system, lung, endocrine glands, nervous system, kidney, blood cells, and musculoskeletal system.
Source: Journal of Hepatology - Category: Gastroenterology Authors: Tags: Review Source Type: research
AbstractPurpose of the ReviewThe purpose of this review is to outline the role of echocardiography in identifying patients at increased cardiovascular risk for cancer treatment-associated cardiotoxicity.Recent FindingsWith a wide array of cancer therapeutics, a variety echocardiographic cardiotoxicity phenotypes have been identified. Recent consensus statements from several professional societies have provided a framework for risk assessment prior to cancer therapy that involves assessment and optimization of cardiac risk factors but also involves echocardiographic evaluation of left ventricular (LV) function at baseline, ...
Source: Current Cardiovascular Imaging Reports - Category: Radiology Source Type: research
Sousa Éric Robert Lluis M. Mir The effectiveness of electrochemotherapy (ECT) in local eradication of tumours in human and veterinary medicine has been proven. ECT consists of increasing the uptake of cytotoxic drugs by means of pulsed electric fields (PEFs) that transiently permeabilise the cell membrane. Still, this tumour treatment includes some drawbacks that are linked to the characteristics of the intense electric pulses (EPs) used. Meanwhile, the emerging field of cancer therapies that are based on the application of non-thermal plasmas (NTP) has recently garnered interest because of their potentiali...
Source: Cancers - Category: Cancer & Oncology Authors: Tags: Article Source Type: research
In conclusion, miR-346-5p may promote CRC growth by targeting FBXL2 and activating the β-catenin signaling pathway. MiR-346-5p may be a novel target in cancer therapy.Graphical abstract
Source: Life Sciences - Category: Biology Source Type: research
Publication date: Available online 14 January 2020Source: Acta Pharmaceutica Sinica BAuthor(s): Yuan Fang, Guochao Liao, Bin YuAbstractBlocking the MDM2/X–P53 protein–protein interaction has been widely recognized as an attractive therapeutic strategy for the treatment of cancers. Numerous small-molecule MDM2 inhibitors have been reported since the release of the structure of the MDM2–P53 interaction in 1996, SAR405838, NVP-CGM097, MK-8242, RG7112, RG7388, DS-3032b, and AMG232 currently undergo clinical evaluation for cancer therapy. This review is intended to provide a comprehensive and updated overview ...
Source: Acta Pharmaceutica Sinica B - Category: Cancer & Oncology Source Type: research
.
Source: Health Communication - Category: Health Management Authors: Source Type: research
ACS Applied Materials&InterfacesDOI: 10.1021/acsami.9b21214
Source: ACS Applied Materials and Interfaces - Category: Materials Science Authors: Source Type: research
Authors: Regua AT, Doheny D, Arrigo A, Lo HW Abstract Tropomyosin receptor kinases (TRKs) were first identified in 1986 when NTRK1 was discovered as part of an oncogenic fusion gene in colorectal cancer and the discovery of NTRK2 and NTRK3 followed shortly after. In the decades since their discovery, TRKs have been implicated in a number of cancer types due to their canonical roles in promoting cell proliferation and survival. Studies have shown that increased expression and/or activity of TRKs can be indicative of metastatic potential, suggesting that TRKs can be therapeutic targets in aggressive cancers. While pr...
Source: Discovery Medicine - Category: Research Tags: Discov Med Source Type: research
Numerous studies have shown that berberine and its derivatives demonstrate important anti-tumor effects. However, the specific underlying mechanism remains unclear. Therefore, based on systems pharmacology, this review summarizes the information available on the anti-tumor effects and mechanism of berberine and its derivatives. The action and potential mechanism of action of berberine and its derivatives when used in the treatment of complex cancers are systematically examined at the molecular, cellular, and organismic levels. It is concluded that, with further in-depth investigations on their toxicity and efficacy, berber...
Source: Frontiers in Pharmacology - Category: Drugs & Pharmacology Source Type: research
More News: Cancer | Cancer & Oncology | Cancer Therapy | Genetics | Laboratory Medicine | Medical Devices | Merck