The University of North Carolina at Chapel Hill (UNC) HIV Cure Center and Cell Microsystems, a provider of instruments for the sorting and isolation of single cells, have received an approximately $283,000, 12-month Phase I Small Business Innovation and Research contract from the National Institutes of Health to develop an automated platform to quantify the latent HIV reservoir.

As researchers develop therapies to reverse HIV latency—a step toward clearing the virus from the body—an accompanying diagnostic test is also needed to accurately measure the viral reservoir and judge the efficacy of these new latency reversal agents.

The collaboration between UNC and Cell Microsystems aims to fill this need by using Cell Microsystem’s automated images analysis tools, the CytoSort Array and CellRaft AIR system, to screen and isolate thousands of patient-derived cells to detect emergence of HIV after exposure to potential therapeutics. If Cell Microsystem’s solutions accurately quantify the viral reservoir, the company along with UNC will apply for Phase II funding to explore the project’s commercial and scientific viability.

 “We are very excited the CellRaft Technology will be utilized by a world-class team of investigators toward a historically intractable problem,” said Nick Trotta, PhD, Cell Microsystem’s director of product applications and market development. “As we talk to more HIV investigators, it’s clear that the platform has a lot of advantages that uniquely address the latency reversal drug screening process. We are also eager to contribute our genomics capabilities to better understand the precursors of HIV latency reversal.”

Prescient Medicine, Metabiomics to Develop Microbiome-Based GI Health Tests

Prescient Medicine and Meta-biomics are collaborating to develop a microbiome diagnostics platform for detecting precancerous colon polyps and diagnosing other types of gastrointestinal (GI) diseases including Crohn’s, colitis, and irritable bowel syndrome. These assays will apply Metabiomics’ MultiTag next-generation sequencing and microbiome analytics platform to detect warning signs of polyps and carcinogenesis in the colon. The partnership is currently aiming for the new tests to be available in 2020.

“The interrogation of the gut microbiome in order to assess GI health and predict colon cancer risk is a total game changer,” said Greg Kuehn, chief operating officer of Metabiomics. “Gastroenterologists have known for a long time that gut microbes are associated with GI disease. Now we’re finally applying these new metagenomics tools to analyze gut microbial DNA and bringing our understanding of GI disease to a new level.”

Qiagen to Acquire NeuMoDx, Commercialize NeuMoDx PCR Systems

Qiagen has signed an agreement to acquire the remaining 80.1% of NeuMoDx shares that it does not currently own at a predetermined price of approximately $234 million. Separately, the two companies also entered a strategic partnership to commercialize two of NeuMoDx’s new fully integrated systems for automation of polymerase chain reaction testing, the NeuMoDx 288 (high-throughput version) and NeuMoDx 96 (mid-throughput version).

These next-generation systems are designed to help clinical molecular diagnostics’ laboratories process increasing test volumes and deliver more rapid insights on a broad range of diseases. Under the terms of the agreement, Qiagen will initially distribute the NeuMoDx 288 and NeuMoDx 96 in Europe and other major markets outside of the U.S., while NeuMoDx will cover the U.S. directly.

Qiagen intends to begin commercialization of the NeuMoDx systems with an initial assay menu including the systems’ first two CE marked assays, which are for Group B Streptococcus and Chlamydia trachomatis/Neisseria gonorrhoeae infections.

Bristol-Myers Squibb, Natera to Evaluate ctDNA Lung Cancer Co-Diagnostic

Bristol-Myers Squibb has entered an agreement with Natera to use the company’s Signatera circulating tumor DNA (ctDNA) assay in a study to determine whether the test can serve as a co-diagnostic for adjuvant non-small cell lung cancer therapy.

Led by Charles Swanton, MD, PhD, of the Francis Crick Institute, the study will use the Signatera ctDNA assay to select patients who have minimal residual disease after surgical resection to receive adjuvant standard of care with or without Bristol-Myers Squibb’s drug Opdivo (nivolumab).

The first patient is expected to enroll in 2019 once Natera completes validation of the Signatera ctDNA assay under CLIA. “Our goal is to potentially use the learnings from this study to serve as Natera’s framework with other companies to investigate novel approaches from the metastatic setting in early-stage treatment,” said Matthew Rabinowitz, PhD, Natera CEO. “We believe that our technology will potentially enable treatment selection for patients most likely to benefit.”

Seven Bridges, e-NIOS Team to Improve Biomarker Extraction From Omics Data

The biomedical data platform and analytics company Seven Bridges has joined forces with the start-up e-NIOS in an effort to improve derivation of robust biomarkers from next-generation sequencing and multi-omic data. Together, the two companies will leverage machine learning and physiology to partially automate interpretation of potential biomarkers.

The partnership will use e-NIOS’ technology, which enables unsupervised translation of omics data through BioInfoMiner, a cloud platform that resolves biological complexity and derives molecular signatures suitable for data-driven interpretation. “e-NIOS’ technology has the unique ability to combine biological network information with data-driven models,” said Brandi Davis-Dusenbery, CEO of Seven Bridges. “Our strategic partnership supports Seven Bridges’ mission to connect the world’s biomedical information and rapidly transform it into actionable information.”

The project will also leverage the Seven Bridges Platform, a high-performance cloud computing service for streamlined processing of massive genomic datasets.

Merck, Definiens Partner on Immuno-Oncology Biomarker Discovery

Definiens will support Merck’s exploratory and clinical immunotherapy development programs with the Definiens TissuePhenomics solutions, which quantify biomarkers for immunoprofiling and enable users to share data via web-based collaboration software. Based in Munich, Germany, Definiens focuses on tissue-based biomedical digital imaging and data visualization, mining, and analysis.

“This partnership agreement is a testament to Definiens’ ability to transform tissue image data into valuable insights using our proprietary data mining methods for biomarker discovery,” said Oliver Lehner, vice president of Definiens business development and partnering.

In addition to providing Merck with digital tissue analysis tools, Definiens will provide a dedicated team to help Merck maximize synergies between its immuno-oncology projects. Merck believes that the tissue diagnostics and biomarker data gained through this collaboration will enable the company to make more informed decisions about its immuno-oncology product development portfolio.