Friday, March 22, 2019

What Elizabeth Holmes and Theranos Got Wrong About Diagnostics

For Fibronostics

It was a promise too good to be true – a bread maker-sized box that could analyze a single small blood sample for 200 different illnesses and conditions.

The idea was so attractive and the inventor so convincing that such sophisticated investors as media mogul Rupert Murdoch, the Walton family, Betsy DeVos and others invested upwards of $100 million each to get in on the ground floor of what was perceived to be a Silicon Valley startup that would disrupt healthcare the way Apple disrupted mobile phones. (published site)

The problem? it really was too good to be true.

In a compelling HBO documentary, The Inventor: Out for Blood in Silicon Valley, director Alex Gibney (Enron: The Smartest Guys in the Room) lays out the story of Elizabeth Holmes and Ramesh Balwani who founded a medical device company called Theranos that raised over $700 million in investments between 2013 and 2015 to develop the “laboratory in a box” technology.

The documentary chronicles Holmes’ tale of good intentions gone awry from her dream of democratizing healthcare by reaping vast amounts of data from a few drops of blood, to the inevitable unraveling of the company once valued at $9 billion.

One of the reasons Holmes’ idea might have been so attractive to so many were the genuine advances taking place in diagnostic blood testing. Such tests were showing promise of diagnosing aggressive forms of prostate and breast cancer, lupus, Alzheimer’s, liver disease, and others.

Consequently, a single device that could combine all the tests in single box seemed plausible to people with little understanding of blood tests. To those who knew better, however, such as Phyllis Gardner, one of Holmes’ professors at Stanford, it was impossible to derive such broad diagnostic information from a tiny blood sample. In the end, Gardner was proven right, Theranos’ blood testing device, called Edison, couldn't accurately detect enough molecules in blood samples to provide accurate readouts.

The spectacular crash of Theranos and the extent of the fraud shown in the newly released documentary have some in blood diagnostic research concerned that the fallout may ripple through the research and clinical segments of healthcare making it more difficult for researchers to obtain needed funding and possibly even casting doubts among consumers about the validity of currently well-established blood tests.

The problem is that there are dozens of legitimate research projects under way that are seeking to develop what are loosely called point-of-care diagnostic testing. One of them is Dr. Paul Yager, former director of bioengineering at the University of Washington in Seattle.

He summed up the fallout from Theranos. “For the last four years, anyone that's been talking about point-of-care diagnostics in front of investors has had to say 'and we're not like Theranos,' Dr. Yager told Mashable, an online tech magazine.

In the aftermath of the collapse of Theranos it is clear that Holmes’ claims stand in stark contrast to the diagnostic capabilities developed through the painstaking advances of legitimate researchers. Theranos made fraudulent claims hidden by lies, deceptive demonstrations and misrepresentations of a far-reaching technology supposedly developed in just a few years that far outstripped the state-of-the-technology.

By contrast legitimate researchers have spent decades identifying and validating biomarkers of disease that can be isolated from blood.

Holmes promised Edison could screen for multiple infectious diseases such as HIV and syphilis from a pin prick blood sample. Hematologists and infectious disease researchers know that to culture infections you need a specific amount of blood to get an accurate reading.

In short, legitimate researchers, while employing amazing technology such as artificial intelligence, are in fact developing a range of digital diagnostic testing and screening technologies for analyzing, assessing and evaluating a broad range of diagnostic parameters faster, easier, more accurately, but they are much more targeted to disease-specific conditions, and far less sweeping than what Theranos claimed it could do.

A case in point is the LiverFAStTM test developed by Fibronostics using artificial intelligence that built off decades of research identifying noninvasive biomarkers for liver disease, and additional decades of validation testing for multi-marker indices and tests. Technology is continuing to evolve in the Healthcare Industry and digital diagnostic tools are breaking barriers that previously limited doctors and patients.

With ‘machine-learning’ algorithms using the data of thousands of patients combining parameters such as age, gender, body mass indicator (BMI) and up to 9 selected blood biomarkers Fibronostics’ LiverFAStTM test is blood test targeted to liver disorders.

We don’t claim to definitively diagnose, rather our test yields a ‘score’ indicating a patient’s stage of liver disease that is an effective alternative to surgical biopsy or imaging that offers accuracy and minimizes the cost and risks. LiverFAStTM can effectively identify those patients who may need biopsy confirmation of disease, and perhaps more importantly those patients who can safely forgo the risks of invasive needle biopsy.

At Fibronostics, our passion for non-invasive digital diagnostics drives us towards creating solutions that allow you to monitor risk and detect disease, with the goal of eventually forgoing the traditional biopsies and scans that are currently common practice.

The LiverFASt™ family of tests for monitoring risk and detecting disease in your liver help you and your doctor to better understand the health of your liver so that you can stay ahead of the silent killer of liver disease.

Contact us via email, or by phone at 1-888-552-1603 today to learn more about our LiverFASt™ family of diagnostic tests.

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