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In Brief This Week: LineaRx, OncoCyte, Vela Diagnostics, CosmosID, More

NEW YORK – Applied DNA Sciences subsidiary LineaRx said it has expanded an existing joint development agreement with Takis Biotech to include preclinical development of a linear DNA vaccine against 2019-nCoV, the novel coronavirus that originated in Wuhan, China. LineaRx said that its PCR-produced linear DNA provides advantages for this purpose such as speed of production, the absence of antibiotics and their resistance genes, DNA purity, simplicity of design, powerful immunogenicity proved in a prior linear DNA vaccine, the absence of bacterial contaminants, and the fact that the vaccine gene is effective without insertion into the patient's genome.

"We have a patented and proprietary platform for the production of linear DNA that empowers rapid development and large-scale production that we believe will yield a safe and effective vaccine with fewer risks than other DNA production platforms," James Hayward, president and CEO of Applied DNA and LineaRx, said in a statement. "As is typical for RNA viruses, coronaviruses mutate at rapid rates that require constant surveillance. We believe that one of the many benefits of PCR-produced linear DNA is the rapidity at which a putative vaccine can be revised to accommodate mutational drift."

Four US legislators announced they have formed a bicameral, bipartisan Congressional Personalized Medicine Caucus.

"As genomic sequencing becomes less expensive, opportunities increase to diagnose patients sooner and treat them more effectively," Rep. Eric Swalwell, D-Calif., a caucus cochair, said in a statement. "This caucus will go a long way toward ensuring that all American patients benefit from these and other transformative scientific developments in personalized medicine."

Swalwell is joined as cochair by Sens. Tim Scott, R-S.C., and Kyrsten Sinema, D-Ariz., and Rep. Tom Emmer, R-Minn.

OncoCyte has closed its previously announced merger agreement with Insight Genetics, which gives the firm a new immuno-oncology diagnostic test, as well as various other diverse technology and pharma service offerings including targeted therapeutic panels and a pharma trial lab compliant with 21 C.F.R Parts 820 and 11.

At closing, Oncocyte delivered $6.4 million in cash, which was net of a $0.6 million cash holdback, plus 1.9 million shares of Oncocyte common stock valued at $5 million. “While our current focus is on lung cancer, this acquisition significantly expands our suite of proprietary tests to manage key decision points potentially across multiple stages and types of cancers,” OncoCyte CEO Ron Andrews said in a statement.

The US Food and Drug Administration has classified Vela Diagnostics' Sentosa SQ HIV Genotyping Assay, a sequencing-based HIV drug-resistance genotyping assay, as class II (special controls). The agency determined that classifying the device as such will provide a "reasonable assurance of safety and effectiveness of the device" and will "enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens" that occur when a device is placed into a lower class than the automatic class III assignment. FDA said that the automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device, and that the agency may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II.

The Sentosa assay received FDA approval through the agency's de novo premarket review pathway in November. It is the first HIV drug resistance assay using NGS technology authorized for marketing in the US.

ProQR Therapeutics said it is participating in the Foundation Fighting Blindness My Retina Tracker Program, a collaborative, open-access program run by the Blueprint Genetics and InformedDNA to provide no-cost genetic testing and counseling to individuals with a clinical diagnosis of an inherited retinal disease (IRD). Genetic testing in the My Retina Tracker Program is performed by Blueprint Genetics and tests a broad panel of known mutations causing IRDs, including mutations causing LCA10, Usher syndrome, and retinitis pigmentosa for which ProQR is developing medicines. As a partner of the program ProQR has access to expert physicians and deidentified data from specific participating IRD patients, which would facilitate its efforts to advance new IRD treatments, the company said.

Microbial genomics company CosmosID and Bioeostasis, a preclinical CRO that offers in vivo research servces for metabolic and GI diseases, announced a strategic partnership to provide standardized, end-to-end services for the preclinical development of next-generation microbiome-based health products. The collaboration will aim to integrate relevant and tailor-made, in vivo, preclinical development studies offered by Biomeostasis' rodent facility with CosmosID's standardized GLP workflows and strain-level microbiome analysis to achieve superior model selection, address model-to-model microbiome variability, and collect longitudinal microbiome data from various rodent models.

Neogen, a developer of products including genomic testing solutions for food and animal safety, said that it has partnered with food industry blockchain company Ripe Technology to adapt blockchain technology for use with Neogen's food safety diagnostics and animal genomics. The blockchain technology will be initially separate from the Neogen Analytics platform, which enables Neogen customers to automate food safety workflows, and continuously monitor and analyze food risk data generated by the company's food safety diagnostic products. When fully integrated, the company believes the two technologies can form the basis for advanced data-driven decisions for its customers.

Neogen, based in Lansing, Michigan, also said this week that it has acquired UK-based Abtek Biologicals, a developer and supplier of culture media supplements and microbiology technologies.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.