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Vermillion, Colorado Prevention Center, Active Motif, Center for Information Technology, Theranostics, Duke University, Chromatide, Novasep, Crucell, Bioceros, Miraculins, National Institutes of Health

Vermillion Chooses Colorado Prevention Center for PAD Test Clinical Test Design
Vermillion has selected the Colorado Prevention Center as its academic research organization in connection to the company’s blood-based test for peripheral arterial disease, the company said this week.
CPC will participate in the design of a clinical study to support clearance of the test, called VASCLIR, by the US Food and Drug Administration. In a statement, Gail Page, president and CEO of Vermillion, said CPC was chosen for its extensive experience “in designing and executing high-quality, cost-effective clinical studies in the field of cardiovascular disease.”
Terms of the deal were not disclosed.

NIH Licenses Active Motif Software to Support Salivary Proteome Project
Active Motif announced this week that it reached a multi-year agreement to license its AlmaKnowledgeServer 2 software to the Center for Information Technology at the National Institutes of Health.
AlmaKnowledgeServer 2 is text-mining software developed by Spanish bioinformatics firm Bioalma. CIT will use it to support an annotation platform for the human salivary proteome project aimed at supporting the discovery of saliva-based diagnostic tests.
Financial terms of the deal were not disclosed.
Active Motif, based in Carlsbad, Calif., sells antibodies, assays, and fluorescent dyes.

Theranostics Gives Duke Investigators Access to LCM, RPMA Technologies
Theranostics Health and Duke University have entered into an agreement giving researchers at the school access to Theranostics’ Laser Capture Microdissection and Reverse Phase Protein Microarray technologies, the company said last week.
The technologies can be used to measure aberrant protein signaling and the protein molecular networks used by tumor cells obtained directly from a patient’s biopsy, Theranostics said in a statement. That information can then be used to evaluate patient-specific treatments and to better understand the mechanisms of tumorigenesis to discover and develop new and safer therapies.
Terms of the deal were not disclosed.

Chromatide, Novasep Extend Partnership
Chromatide and Novasep have extended a partnership for the development of solid-phase peptide and oligonucleotide synthesis technology, the companies said last week.
The partnership was originally forged in 2006 and combines Chromatide’s expertise in solid-phase synthesis, especially in the fields of peptide and oligonucleotides synthesis, with Novasep’s expertise in synthesis services, chromatography, filtration and crystallization technologies, as well as processes used in the pharmaceutical and biotechnology sectors.
The goal of the partnership is to finalize the co-development of large-scale peptide and oligonucleotide synthesis process, equipment, and systems “to meet the growing needs of biotechnology and pharmaceutical industries for more efficient, continuous-flow instruments for gram to industrial-scale production of high-quality products,” the companies said in a statement.
Terms of the deal were not disclosed.

Crucell, Bioceros Reach Deal for Monoclonal Antibody Production
Dutch pharmaceutical firm Crucell said this week it has reached a non-exclusive deal with Bioceros for the production of monoclonal antibodies.
Financial terms of the deal were not disclosed.
The agreement involves the use of Crucell’s STAR Technology for the production of recombinant human antibodies and proteins. Crucell focuses on R&D, production, and marketing of vaccines, proteins, and antibodies for the prevention and treatment of infectious diseases.
Bioceros, also based in the Netherlands, focuses on the pre-clinical development of protein products with an emphasis on monoclonal antibodies. Its technology platform consists of generating high protein-producing CHO cell lines, process development, and pre-clinical manufacturing at 20-liter scale in disposable reactors.

Miraculins Plans Second Study for Prostate Exam
Miraculins said this week that it will conduct a second pre-biopsy screen study for its urine-based prostate cancer diagnostic test after feedback from the US Food and Drug Administration indicated the company needed to look at patients who had elevated PSA levels but may not have prostate cancer.
In November, the company filed a pre-investigational device exemption with the FDA to seek informal input on its first study for the P2V prostate cancer diagnostic test. The test looked at a broad swath of men including those with extremely high PSA scores and irregular digital rectal exam scores. Based on the feedback from the agency, Miraculins eliminated the data of patients with PSA scores greater than 10 nanograms per milliliter and those with irregular DRE scores.
Doing so, however, left Miraculins with a “vastly reduced” data set, the company said in a statement. As a result, it decided it needed to do a second test looking specifically at men with a PSA score between 2.5 nanograms per milliliter and 10 nanograms per milliliter and with a normal DRE result.
“The objective of the study will be to determine the effectiveness of the P2V test in reducing the number of unnecessary biopsies in this key group of patients by being able to screen out the men who have been selected for a prostate biopsy based strictly on their elevated PSA score, but who do not have prostate cancer,” the company said.
The company will also test the samples from the second study using immunoassays for PSP94 and Vitronectin, the proteins that form the basis for the P2V test, the company said. 
The company plans to begin the study in about 30 days.

NIH Using ‘Omics’ to Study Mystery Ailments
In an effort to discover and find the causes for a variety of undiagnosed diseases, the National Institutes of Health plans to start a new program that will bring to bear the knowledge and resources of its many institutes, including those focused on genomics and proteomics, on patients who have uncommon or unknown conditions.
The trans-NIH Undiagnosed Diseases Program “will aim to provide answers to patients with mysterious conditions that have long eluded diagnosis,” NIH said in a statement this week, and it will “focus on the most puzzling medical cases” that are referred to the NIH Clinical Center.
NIH Director Elias Zerhouni said that “the history of biomedical research has taught us that careful study of baffling cases can provide new insights into the mechanisms of disease — both rare and common.
“The reason we’re doing this now is because of the many advances of the last five years, the new techniques of proteomics, genomics,” Zerhouni elaborated in a conference call. “That’s the significance of this effort — using the tools that come out of the lab” to apply to human diseases, he added.
The UDP will use existing staff and facilities at the NIH Clinical Center, the National Human Genome Research Institute, and the NIH Office of Rare Diseases, and will see around 100 patients each year who have been referred by physicians.
The program will be directed by William Gahl, who also is clinical director at NHGRI, and it will include a group of over 25 senior attending physicians from various fields who will evaluate and review patients’ cases.
“We expect this program will create many new articles, new science, and new treatments,” Gahl said in the conference call. “This program will offer real hope,” Gahl added, “but it is a research program.”
Cases will be submitted by physicians, and a review panel will decide if they are right for the UDP, Gahl said.
The project is funded with $280,000 per year so far from the Office of Rare Diseases, and Gahl said that ORD funding is scheduled to last four years.
That may sound like a small amount of funding to run an NIH program, but Gahl explained that the UDP will primarily be using resources, technology, and expertise already within the institutes.
Gahl also said he thinks this program could be expanded even before the four-year period is up if “we have a long line of people waiting” to join the program, and “because people believe in this enough,” he said.
Gahl said the program plans to put both clinical and lab information into a database, and that in the future it will be able to scan and compare genetic information as well as medical records and test results in the database with others.
“I think if we were to see five different people who have a similar rare disease,” Gahl said, “we also could go back and ask to get DNA samples from other members of their family” in the hunt for genetic links to the disease.
Matt Jones (This article originally appeared in ProteoMonitor’s sister publication GenomeWeb Daily News)

The Scan

Researchers Compare WGS, Exome Sequencing-Based Mendelian Disease Diagnosis

Investigators find a diagnostic edge for whole-genome sequencing, while highlighting the cost advantages and improving diagnostic rate of exome sequencing in EJHG.

Researchers Retrace Key Mutations in Reassorted H1N1 Swine Flu Virus With Avian-Like Features

Mutations in the acidic polymerase-coding gene boost the pathogenicity and transmissibility of Eurasian avian-like H1N1 swine influenza viruses, a PNAS paper finds.

Genome Sequences Reveal Evolutionary History of South America's Canids

An analysis in PNAS of South American canid species' genomes offers a look at their evolutionary history, as well as their relationships and adaptations.

Lung Cancer Response to Checkpoint Inhibitors Reflected in Circulating Tumor DNA

In non-small cell lung cancer patients, researchers find in JCO Precision Oncology that survival benefits after immune checkpoint blockade coincide with a dip in ctDNA levels.