 Blood-test startup Theranos defends 'integrity' Laguna Beach, United States (AFP) Oct 22, 2015 - The founder of innovative blood test startup Theranos on Wednesday challenged The Wall Street Journal on its own turf about an investigation into the firm's technology. Elizabeth Holmes took to the stage at the prestigious WSJDLive technology conference on the Southern California coast to say the Journal got the story wrong. "We know the integrity of what we have done and regulators have looked at it," Holmes said during an interview with Wall Street Journal global technology editor Jonathan Krim. The Journal released a statement standing by its report, which raised questions about whether the Silicon Valley-based startup was delivering as promised when it came to tests done from blood drawn by simple pin pricks. The newspaper accused Theranos of using nothing more revolutionary than widely available commercial equipment. "Nothing said at the conference by Ms. Holmes refutes the accuracy of the reporting done by John Carreyrou or of the articles," the Journal said. "The Journal reiterates that our articles about Theranos were thoroughly reported, fair and wholly accurate." Holmes maintained otherwise during the on-stage interview, contending that concerns about Theranos testing methodology in the report were "completely false." "We know what we are doing and are very proud of it, using finger prick testing and trying to expand the universe of how many tests are available," Holmes said. Theranos has been cleared by US regulators for one kind of blood test as part of a procedural strategy to expand the line-up of tests from there, according to Holmes. She said Theranos has done more than 3.5 million blood tests. Theranos is among Silicon Valley unicorns -- private startups with valuations of a billion dollars or more based on money pumped in by investors. The startup, which ironically operates in a building that was occupied for decades by The Wall Street Journal in the city of Palo Alto, has recently been valued at about $9 billion. Theranos boasted of being able to do blood tests faster, more economically, and with only a tiny finger prick instead of needing vials of blood. Theranos is continuing its work under the watchful eyes of regulators, according to its chief. "Just because some guy reports false stuff about us doesn't mean it changes our business," Holmes said.
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Two years after personal genetics startup 23andMe was ordered by US authorities to stop selling its DNA test kits, a revamped product has gained market approval, the company said Wednesday.
The California-based firm announced the launch of its new "Personal Genome Service," which will test for mutations that could lead to disease.
"We've worked with the FDA (Food and Drug Administration) for nearly two years to establish a regulatory path for direct-to-consumer genetic testing," said a statement by 23andMe co-founder and CEO Anne Wojcicki, ex-wife of Google co-founder Sergey Brin.
"We are a better company with a better product as a result."
The new product is a "complete redesign," offering "an entirely new experience," for $199, said the statement from the company, which is named after the 23 pairs of chromosomes in the human body.
Customers will get "a detailed but easy to understand genetic information service," along with ancestry and wellness reports.
The company also promised "personalized insights based on analysis of 650,000 genetic variations," and the "only service available direct-to-consumer with reports that meet FDA standards."
It also mentioned "the chance to find and connect with DNA relatives in a database of more than one million customers."
The FDA had barred the company in 2013 from selling its saliva analysis kit aimed at helping customers determine their genetic risks for diseases such as diabetes, coronary heart disease and breast cancer, saying it was a "medical device" which required regulatory approval.
- New overhaul -
Medical experts said the company's test has been completely overhauled, including no longer offering risk analysis on major illnesses such as heart disease, breast cancer and Alzheimer's.
"The company is not testing the diseases that raised most concerns in the past," said Cecile Janssens, professor of epidemiology at Emory University, who described the new product as "substantially improved" in terms of information provided.
"It does not test predisposition to common diseases such as heart attack, asthma and hip fractures, for which lifestyle factors are often more important; it does not test high risk variants such as BRCA1 and BRCA2 for breast and ovarian cancer and APOE for Alzheimer's."
Instead, the test looks for carrier mutations, or specific gene changes, known to cause health issues when children receive the mutations from both parents.
"The tests are not intended to diagnose a disease, or tell you anything about your risk for developing a disease in the future," said a company statement.
Rather, the information should mainly be used to learn how DNA relates to these traits, it said.
"Tests for carrier mutations have existed for years and have been available through doctors' offices, especially for future parents who were concerned about the possibility of hereditary disease," said Brian Zikmund-Fisher, associate professor of health behavior at the University of Michigan.
"One concern about informing people that they have these types of carrier mutations is that people may not know how to process the information without help."
Consumers should also be aware that their genetic data may be shared, according to Dietrich Stephan, chairman and professor of the department of human genetics at the University of Pittsburgh Medical Center.
"Their genetic data and their self-reported survey data are being pushed to internal pharmaceutical development and may be shared with external pharmaceutical partners outside of 23andMe," he added.
"It's legal and above board, but important for consumers to be aware of."
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