Issue 2  October 30th 2015

OK, Theranos: Here’s the Data the World Needs to See

Theranos, a company valued at $102 billion US, increased its market share in the clinical lab testing industry with its Edison fingerstick technology, lower pricing, and retail concept. However, striking controversy has been overshadowing these results after media accounts provided discrediting reviews of the company recently.

A Wall Street Journal investigative report, which included former employee interviews has focused attention on the company. In response to the claims, Theranos released a statement stating, “Today’s Wall Street Journal story about Theranos is factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents.”

In mid-September, Theranos received two inspection forms (report 1, report 2) from the Food and Drug Administration which stated that inspectors had discovered objectionable conditions which were believed to be in violation of federal law. In August and September, locations were inspected over a three-week period and showed that Theranos had misclassified its Nanotainer blood collection device as a low-risk medical device, kept inadequate records, was not completing quality audits, and did not correctly handle consumer complaints. Theranos is required to explain or correct 14 “inspectional observations.”

At a conference sponsored by the Cleveland Clinic on Tuesday, Elizabeth Holmes, CEO of Theranos, stated that Theranos was prepared to publish data about its lab tests in an attempt to battle the current quality feud. The New York Times wrote how Holmes “suggested that presenting the data would be more effective than trying to rebut articles in the news media that she said unfairly attacked the company. ‘Data is a powerful thing because it speaks for itself,’ she said.”

Relevant Article: Two FDA Inspection Reports Show Theranos’ Blood-Collection ‘Nanotainer’ Was an Uncleared Class II Medical Device

Relevant Article: OK, Theranos: Here’s the Data the World Needs to See

Blood test could match cancer patients to best treatments

In a study published in Clinical Cancer Research, researchers from the UK examined 160 blood samples from 39 cancer patients of various late stage disease. The study discussed the findings of a developed blood test which can identify and stratify disease to align it with the most suitable drug therapy, as well as contribute to monitoring disease change and response to treatment over time. Professor Johann de Bono, from The Institute of Cancer Research, London, and The Royal Marsden, said: "Tumours and the gene faults that drive them are unique and constantly evolving. It's crucial that we understand these changes so doctors can choose the best treatments for each patient.”

The article demonstrates the feasibility of this blood analysis approach in the context of developmental therapeutics in oncology. The blood test filters out tumour DNA and analyzes it for genetic ‘faults’; Tumor cell genomic alterations can be evaluated by genotyping circulating cell free DNA (cfDNA). Incorporating cfDNA sequencing in the blood analysis makes it possible to match some faults to a targeted drug therapies.

Full Article: Frenel et al. Serial Next Generation Sequencing of Circulating Cell Free DNA Evaluating Tumour Clone Response To Molecularly Targeted Drug Administration. Clinical Cancer Research

Multi-tasking flu vaccine could provide better protection against outbreaks

Each year the seasonal flu vaccine is developed on the statistical prediction of a limited number of predominant flu virus strains. A team of researchers from Australia have released a publication in mBio, an open access journal published by the American Society for Microbiology, and have identified how to boost the effectiveness and cross-protective capabilities of an influenza A vaccine through a synthetic lipopeptide additive. It is suspected that this additive stimulates different types of antibody-independent immune responses.

The synthetic was added to an inactivated influenza A vaccine and vaccinated mice, with the mice exposed three days later to both the virus contained in the vaccine and another strain. The mice given the synthetic lipopeptide additive vaccine were better protected compared to the mice that received the vaccine without the additive. In addition, the additive vaccine mice were more likely to survive normally lethal dose of the flu virus. The research team also found that a low dose nasal application vaccine with the additive produced 600 times more neutralizing antibodies and activated more T cells that are responsible for supporting lung function when infected compared to the original vaccine. It was concluded that the additive reduced the transmission of an unmatched flu strain from vaccinated mice to unvaccinated mice housed in the same cage for 2 days.

This research provides future guidance on the development of more effective seasonal flu vaccines for humans and our ability to protect communities in the early stages of an outbreak.