back to article Biotech exec sentenced to eight years for COVID-19 testing finger-stick fraud

A Silicon Valley exec who claimed to have invented a revolutionary technology that could perform diagnostic testing using a single drop of blood from a pricked finger has been sentenced to eight years in prison for his role in the multi-million-dollar fraud scheme. No, not that Silicon Valley biotech exec. And no, apparently …

  1. heyrick Silver badge

    You would have thought there would be some regulatory oversight

    Which would be necessary before setting oneself up as any sort of medical facility.

    1. SVD_NL Silver badge

      Re: You would have thought there would be some regulatory oversight

      "After obtaining these certifications through fraudulent means"

      To me this is the most worrying part. This is the catalyst that allowed for all of the other fraud, because everyone seems to trust these certifications.

      How can multiple certifications *this* important to public health, be obtained fraudulently from multiple different authorities?

      How is it possible they get certifications for allergy testing, and they can use that for COVID testing too? do these certifications not need a specification of seperately certified testing equipment for each test?

      Why did insurance companies accept claims of the allergy-COVID bundles if they were that much more expensive? If this is somehow an inseperable bundle, it surely wouldn't be more expensive?

      I get that they were desperate to get more COVID testing capacity, but desperation is not an excuse for carelessness and negligence.

      The system in place is either completely messed up, or there is a lot more corruption than the indictment lists...

      1. Doctor Syntax Silver badge

        Re: You would have thought there would be some regulatory oversight

        "Why did insurance companies accept claims of the allergy-COVID bundles if they were that much more expensive?"

        Higher premiums?

        1. SVD_NL Silver badge

          Re: You would have thought there would be some regulatory oversight

          Maybe, but among these companies is medicare too, which is a government entity with a lot of incentive to cut costs.

          And medical insurance companies (especially in the US) are known to be ruthless with denying diagnostic tests and treatment.

          Look up prior authorisation, you'd think that they are very strict about what tests they'll pay for.

      2. ecofeco Silver badge

        Re: You would have thought there would be some regulatory oversight

        It's not corruption, it's lack of resources. In other words, the "watchdog" agencies have all been deliberately crippled by, well, take a wild guess at who is cutting their funding and appointing apparatchiks.

        1. John Brown (no body) Silver badge

          Re: You would have thought there would be some regulatory oversight

          I can't quite work out whether you're having a pop at the current US administration or the previous one. It sounds present tense, but the fraud appears to have happened almost exclusively under the previous one. Or maybe it;s both?

  2. Anonymous Coward
    Anonymous Coward

    Fraudulent COVID Test? Do Tell

    So when are the labs and medical community that use the fraudulent PCR tests going to be prosecuted? Even the inventor of the PCR test said it is not reliable as a diagnosis. It creates too many false positives to be reliable, especially if you stretch it to too many cycles.

    1. Steve Button

      Re: Fraudulent COVID Test? Do Tell

      Not the same ball park. While false positives can be a problem when you have low incidence of a disease, especially with a high CT, it's still only very low single digits. This could mean that if you are testing millions, you could see 10s of thousands of false +ve.

      This is not the same thing as having a completely fraudulent test.

    2. imanidiot Silver badge

      Re: Fraudulent COVID Test? Do Tell

      Reliable enough for a fast spreading and extremely virulent virus like SARS-COV-2. PCR tests (as a testing method) weren't/aren't fraudulent. That's not to say there may or may not have been fraud, but that will probably have been majority "providing a negative test result regardless of test outcome or even regardless of whether a test had actually been done.

      If we were testing for something where a positive outcome equals "must be put to death immediately" then yes, you'd better be damn sure a positive means a positive. In case of "might be mildly inconvenienced for a week based on the outcome" like with a COVID PCR test? Some small percentage false positives is acceptable.

    3. SVD_NL Silver badge
      Boffin

      Re: Fraudulent COVID Test? Do Tell

      "Not as reliable as a diagnosis"

      PCR is a diagnostic tool, the results are not a diagnosis. They are to be used in combination with clinical presentation, among other aspects. It is also used to determine if you carry the virus, you can carry the virus asymptomatically too.

      "The inventor of X has said..."

      The inventor is not a definitive source for information about a certain technology. Peer-reviewed research is.

      So here is an interesting one:

      Ravikanth, Reddy. "Diagnostic accuracy and false-positive rate of chest CT as compared to RT-PCR in coronavirus disease 2019 (COVID-19) pneumonia: a prospective cohort of 612 cases from India and review of literature." Indian Journal of Radiology and Imaging 31.S 01 (2021): S161-S169.

      https://www.thieme-connect.com/products/ejournals/html/10.4103/ijri.IJRI_377_20

      "In 92.1% of all patients, the results of the chest CT and the PCR test were concordant; however, in 11 (1.7%) of patients with a positive PCR, CT scans were not considered suspicious for COVID-19. In addition, in about 28.2% patients tested negative by PCR, the CT was positive. Most of these patients had a discharge diagnosis of pneumonia (70.2%), which was caused by another viral pathogen in one-half of patients."

      so, for false positive rates, it's going to be basically the same as a chest CT, give or take 1-2%. And that is excluding "false positives" where the CT is positive because of other infectious lung disease.

      Considering CT scans are a little more challenging to do yourself at home, PCR may not be such a bad option.

      This is of course in a group of hospitalized patients, CT scans are going to be useless for asymptomatic patients.

      False negatives are much more of a problem with PCR.. https://doi.org/10.1371/journal.pone.0242958.g002

      False positives are more often than not going to be caused by contamination, mishandling, or mislabeling of samples. (Bezier, Clément, Géraldine Anthoine, and Abdérafi Charki. "Reliability of real-time RT-PCR tests to detect SARS-Cov-2: A literature review." International Journal of Metrology and Quality Engineering 11 (2020): 13. https://doi.org/10.1051/ijmqe/2020014)

      See? That information took less than 15 minutes to gather.

      The inventor may be right, but considering the amount of information and guidelines, not to mention verification, exists for creating tests, that issue is a lot less likely to occur these days.

      I agree that there should be consequences for labs that provide inaccurate test results because of poor operating procedure, and there is definitely a difference in quality between different PCR tests, and companies knowingly selling bad tests should be taken care of too.

      But writing off the technology as a whole because it is not perfect, is not the way to go. It's cheap, reasonably accurate, and it's able to be adapted for many different pathogens and mutations.

      And it definitely doesn't have big problems with false positives...

      1. Strahd Ivarius Silver badge
        Trollface

        Re: Fraudulent COVID Test? Do Tell

        "The inventor of X has said..."

        Should it be: "The inventor of X (formerly known as Twitter) has said..." ?

      2. Benegesserict Cumbersomberbatch Silver badge

        I have a perfect test

        My nose is a 100% sensitive COVID detector.

        If I sniff anyone who asks and say "you have COVID", my test will be positive in 100% of people who have the disease and I would not be defrauding anyone by saying my nose is 100% COVID sensitive, nor even by marketing as such.

        My specificity would be horrible, though. Don't believe me as the inventor of my test - do your research and understand your subject.

        1. SVD_NL Silver badge

          Re: I have a perfect test

          I'll propose it to the ethics board. Surely they won't have a problem with having test subjects sniff people infected with a pathogen!

  3. Big Softie

    And the band plays on

    Lessons will be learned....apparently not

  4. hittitezombie

    Finally

    It's nice to read a heartwarming good outcome story on a rainy and cold Friday morning!

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