April 29, 2020 | April featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Roquette, PGDx, as well as recent attempts to combat COVID-19.
The diagnostics community has been working around the clock to address the COVID-19 pandemic. Companies and universities such as Washington University, OpGen, and others have concentrated their efforts on 3D-printed swabs, biosensors that detect COVID-19 in less than one minute, and much more. Roundup
Roquette has launched an online technical search platform, called “Innovation Hub,” along with its virtual pharmaceutical assistant, named “Rosa,” aimed specifically at research scientists and drug developers requiring immediate access to in-depth research and chemical formulations. The interactive and easy-to-use digital platform is a new innovation for the company, offering product solutions to common formulation challenges in an effort to help developers achieve optimal drug processability and enhanced tabletability while reducing a drug’s time-to-market. “We recognize that the scientific community is determined to collaborate more than ever before,” said Rajeev Gokhale, Head of Pharmaceutical Sciences at Roquette, in a press release. “Innovation Hub supports the digital transformation happening on the bench by more rapidly addressing formulators’ challenges in pre-clinical stages, while allowing developers direct access to our own scientists and their deep level of know-how and scientific expertise.” Press release
Personal Genome Diagnostics (PGDx) announced that the company has received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in a more efficient, reliable, and accurate manner. By automating the data analysis process, which is incorporated in the cleared product, PGDx is enabling the scalability of precision medicine in healthcare systems across the country. “Nearly 80% of patients aren’t getting the clinical insights they need to inform their treatment path, or they aren’t being tested in a window of time that makes a difference in determining their care,” Megan Bailey, Chief Executive Officer, PGDx, said in a press release. “PGDx eliotissue complete responds to this unmet need by bringing genomic cancer testing of the highest quality directly to healthcare providers. Since the founding of our company we have been united in our mission to empower the fight against cancer, and an integral part of that is establishing standardized testing as a core element of patient care. Today is an incredible milestone for us, but more importantly for the millions of people living with cancer.” PGDx elio tissue complete detects single nucleotide variants (SNVs) and small insertions and deletions (indels) in 500+ genes, select amplifications and translocations, and genomic signatures including microsatellite instability (MSI) and tumor mutation burden (TMB). Collectively, the information from this diagnostic kit is intended for use by healthcare professionals to help tailor clinical management for patients based on their tumor’s unique genomic profile in accordance with professional guidelines. The broad genomic profiling assay includes biomarkers to help inform the use of targeted cancer therapies and immunotherapies and can help oncologists identify patients for clinical trial participation. This FDA clearance was supported by a magnitude of data that demonstrates robustness and consistency of performance across multiple lab sites, and accuracy data across all variant classes in clinical samples from 35 tumor types. Press release
Caris Life Sciences announced the submission of two Pre-Market Approval (PMA) applications for MI Exome CDx and MI TranscriptomeCDx to the U.S. Food and Drug Administration (FDA). MI ExomeCDx, whole exome sequencing (DNA), and MI Transcriptome CDx, whole transcriptome sequencing (RNA), are powerful precision medicine assays that include key companion diagnostic biomarkers with therapy claims, and detect all classes of alterations including genomic signatures for microsatellite instability (MSI), tumor mutation burden (TMB), and loss of heterozygosity (LOH). MI ExomeCDx is a next-generation sequencing-based test utilizing DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the qualitative detection of genomic alterations. MI ExomeCDx can identify genetic variants (single nucleotide variants, insertions and deletions), copy number alterations, MSI, TMB and LOH. MI Transcriptome CDx is a next-generation sequencing-based test that utilizes RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the qualitative detection of genomic and transcriptomic alterations. MI Transcriptome CDx is a broad, multi-gene panel utilized to identify gene fusions, transcript variants, genetic variants (single nucleotide variants, insertions and deletions), and gene expression changes. MI Transcriptome CDx received Breakthrough Device designation by the FDA in 2019. Press release
The Critical Path Institute (C-Path) announced that its Type 1 Diabetes (T1D) Consortium has received a letter of support from the European Medicines Agency (EMA) to facilitate the development and validation of the proposed regulatory qualification of pancreatic islet autoantibodies commonly used in clinical practice to diagnose T1D: insulin autoantibodies, glutamic acid decarboxylase 65, and insulinoma antigen-2 autoantibodies as enrichment biomarkers for T1D clinical trials. In their response to the T1D Consortium Letter of Intent (LOI) and Briefing Package, the EMA stated, "[Therapies that preserve endogenous β-cell function and can prevent, halt or slow T1D disease progression in a clinically meaningful way would constitute a significant advancement in T1D care. If successful, the quantitative tools proposed by this Consortium have the potential to facilitate the streamlined design, execution, and review of clinical trials targeting this goal.]." C-Path's T1D Consortium will achieve the regulatory qualification of the islet autoantibodies currently used in clinical practice to diagnose T1D by employing the resources of all its members and engaging with regulatory agencies at each step of the process with funding and input from The Leona M. and Harry B. Helmsley Charitable Trust, Janssen Research & Development, JDRF International, Novo Nordisk, and Provention Bio. Press release
People who approach the front desk at Albert Einstein Jewish Hospital (HIAE) in the city of São Paulo have their temperature taken remotely by a computer vision system installed in a nearby column. Consisting of a thermal camera and armed with facial recognition algorithms, the system scans people's face and measures their temperature automatically. If the system detects a fever, one of the symptoms of COVID-19, its artificial intelligence (AI) software sends a smartphone alert to the duty nurse, who will quickly activate the hospital's triage protocol, isolating the person if necessary to avoid transmission of SARS-CoV-2 in the hospital environment. The system is called Fevver. It was developed jointly by two AI startups based in the state of São Paulo, Hoobox and Radsquare, both of which are supported by Eretz.bio, a healthcare startup incubator operated by the Albert Einstein Jewish-Brazilian Charitable Society (SBIBAE). Hoobox is also supported by the São Paulo Research Foundation - FAPESP Innovative Research in Small Business (PIPE) Program.
Thrive, together with Johns Hopkins University and Geisinger Health, announced data from the landmark DETECT-A study. DETECT-A (Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing) is the first ever prospective, interventional study to use a blood test to screen for multiple types of cancers in a real-world population. The study was conducted by Johns Hopkins University and Geisinger and enrolled more than 10,000 women with no prior history of cancer. The purpose was to identify multiple cancer types in asymptomatic individuals using an early version of CancerSEEK developed in 2016. DETECT-A is the first study of a multi-cancer blood-based screening test to deliver results to physicians to manage patient care. “This study is a seminal moment in cancer screening that advances the entire field,” said Christoph Lengauer, Ph.D., co-founder and chief innovation officer of Thrive, in a press release. “For the first time, a blood test was utilized in a real-world setting and was able to more than double the number of cancers first identified through screening methods. We learned that it can be both complementary to existing standard-of-care screening tools, and a significant benefit for many types of cancers like ovarian, appendix and kidney, which do not have any current screening modalities.” Press release
VERICHEM LABORATORIES announced the availability of a ready-to-use, liquid stable, product expressly designed for the calibration verification of any “wet” chemistry testing system. The ENZYME ER Verifier Kit is a multi-analyte, six level verifier kit of liquid stable materials, comprised of nine separate clinical enzyme components and covering a total of fifty-four individual activities. The enzyme components included within in the materials include Amylase, ALT, ALP, AST, Cholinesterase, CK, GGT, LD, and Lipase. The availability of this unique kit is certain to address the needs of a wide variety of medical laboratory professionals, including those involved with clinical testing, research applications, and in the development and manufacturing of in-vitro diagnostic (IVD) products. The ENZYME ER VerifierKit represents the cutting edge in enzyme test calibration verification materials, as its proprietary formulation is specifically designed to include at least one set point for each enzyme in the normal range. Plus, the use of purified source components and liquid format eliminates matrix variations and reconstitution errors common with lyophilized or serum-based products. In addition, the material’s protein balance, pH, and ion content are constant across concentration levels for optimum linearity. Press release