diagnostics

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NGS Companion Diagnostic Approved by FDA

The US Food and Drug Administration today approved the first next-generation sequencing-based companion diagnostic that can analyze alterations in a panel of genes predictive of response across three non-small cell lung cancer treatments.

The panel, however, gauges alterations in 23 genes in total. The test report will not only indicate whether patients have ROS1, EGFR, and BRAF alterations linked to the three FDA-approved treatments, but also the presence or absence of variants in other genes.

This initial approval makes way for Thermo Fisher to quickly expand the indication of the panel into new markers predictive of drug response. The company is actively working with other drugmakers to expand the indications for the Oncomine Dx Target Test.

Read the entire article at Genome Web.

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Get more genomic news at GenomeWeb

Predictive Gene Expressions

Qiagen has reported that the company and Bristol-Myers Squibb will explore the use of NGS to develop gene expression profiles as predictive or prognostic tools for use with several BMS immuno-oncology therapies. The companies also plan to enter into a further agreement to develop diagnostic products using the jointly developed profiles to expand the use of NGS technology with other BMS immuno-oncology therapies.

“Greater precision in the treatment of cancer may enable faster decision making to identify which patient populations are most likely to derive benefit from our immuno-oncology agents.”

–Fouad Namouni, Bristol-Myers Squibb

This development is an example of the trend towards companion diagnostics, in which the use of predictive biomarkers identify individually-based therapies.
Read the announcement here.

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Get more genomic news at GenomeWeb

From Point of Care to Point of Clinic

Within developed world healthcare systems, there is a growing awareness that the turnaround time of the central laboratory cannot always provide the speed to enable effective and economic decision making.

See full article


Point-of-clinic diagnostic services bring analytical testing from the laboratory to the clinic with the aim of providing prompt, high-quality results.
This is an exciting area of technology that has the potential to impact the lives of many patients and play a significant role in supporting sustainable healthcare systems. Stratified medicine and more individualized approaches to care will become a focus moving forward, and diagnostics will aid the selection of the most effective medicines.

“This facilitates early diagnosis and treatment of health conditions…”

Check the full article at Qmed here.

New Sensor for Early Cancer Detection

A new plasmonic sensor developed by researchers at the University of Illinois at Urbana-Champaign will serve as a reliable early detection of biomarkers for many forms of cancer and eventually other diseases.

Research from University of Illinois

“…instead of needing a vile of blood for a test, a simple finger prick will do.”

For now, detection methods for cancer biomarkers are being implemented in high-risk patients, especially cancer patients in remission. They take time, specialized equipment, and are labor-intensive.
In the future, however, because of the portability and inexpensive nature of this method, it can be more easily administered to any patient at routine check-ups. This would allow those with an elevated concentration of CEA to be treated even before cancer cells spread in the body.
Read the full article at the University of Illinois Engineering site.

Researchers Link Noncoding Genetic Variants to Neurodevelopmental Disorders

Scientists at the Max Planck Institute for Psycholinguistics studying the DNA of children with severe language problems say they have identified genetic variants in the 3′ untranslated region genome (3’UTRome), which is part of the noncoding part of the genome.

“Our study shows that the identification and testing of noncoding variants will foster our understanding of the genetic causes of neurodevelopmental disorders, which is crucial in the long-term for the design of new and effective therapeutics.”

— Sonja Vernes, Ph.D.
Get the full story at Genetic Engineering and Biotechnology News

New Article in GEN

GRAIL Raises $900M to Develop Early Blood Tests for Cancer

GRAIL is combining what it calls high-intensity (ultrabroad and ultradeep) sequencing and population-based clinical trials to characterize circulating tumor DNA (ctDNA) in healthy individuals and cancer patients. The ultimate aim is to develop cancer diagnostics that can detect tumors early enough to cure the disease. See the full story at Genetic Engineering and Biotechnology News.

New Article in GEN


This is a core focus for all precision medicine oncology approaches, including ours. We believe that a multi-omic focus that goes beyond circulating tumor cells can have major advantages.

The Importance of microRNAs

New Article in GEN Explores miRNA

After advances to genomics and transcriptomics technology, scientists have realized that about 98% of the genome contains sequences that perform key regulatory functions. Some of these sequences give rise to microRNAs (miRNAs), small noncoding RNA molecules that have emerged as one of the most complex, multilayered, and intriguing constituents of gene-regulatory networks.

“The future is bright for the diagnostic use of microRNAs”

– Christos Argyropoulos, M.D., Ph.D.

“The goal in biomarker development is to use microRNA expression-based biomarkers to better manage the clinical treatment of cancer,” declares Dr. Jingfang Ju,Ph.D., professor of pathology at the State University of New York at Stony Brook. Historically, mRNA expression, DNA mutations, and proteins have been used as the most common biomarkers.

Expanding the biomarker universe to create new diagnostic and treatment solutions is critical to improving the human condition and a main focus of Forentis Fund. To read the whole article in GEN, click here.