Internationally-respected Experts in Clinical Pathology and Laboratory Medicine Ask: Why Don’t We Know More about Theranos’ Technology?

This secretive start-up medical laboratory testing company has not disclosed how its diagnostic test technology works, nor has it given laboratorians an opportunity to examine the technology

Several internationally-respected clinical laboratory experts are asking serious questions about Theranos and its diagnostic testing technology, and they’ve gotten few answers to date. Though the number of experts is small, their credentials in the clinical laboratory profession are impressive. In addition, some have published their critiques of the start-up medical laboratory company in well-respected medical journals.

One question these clinical pathologists and laboratory directors ask is why Theranos has so far been unwilling to provide more information about the lab testing technology it uses to deliver medical laboratory test results to patients and their referring physicians. Even as the company has declined to speak to the medical laboratory profession, Theranos has mounted a major public relations campaign designed to make a big impression on investors, business partners, and most recently on health insurers.

The clinical laboratory company in Palo Alto, Calif., gets plenty of attention because it claims to have disruptive technology that will allow it to perform medical laboratory tests equivalent to the current standard of care. Theranos says it can do this using a capillary specimen and return results in four hours, while charging a price that is just 50% of Medicare Part B lab test fees. Given these assertions, it is natural that pathologists and laboratory scientists who perform tests for patients, are curious about the scientific basis of Theranos’ proprietary diagnostic technology and what evidence Theranos has developed to support its claims of comparable accuracy and reproducibility. (more…)


Officials in Mexico were criticized as being slow to respond to the spread of A/H1N1 swine flu on Tuesday, April 28. Mexico was reported to have failed to deliver medicine to the families of the dead, two weeks after the first confirmed death from the flu, the Associated Press reported. Also, the government had not determined where the outbreak began or how it spread, the AP said. In Mexico, 159 people may have died of swine flu, but only seven of these deaths have been verified as A/H1N1 by laboratory tests, the New York Times reported today (April 29).



Rapid diagnostic test rRT-PCR Swine Flu Panel cleared by FDA for emergency use

Early today, it was reported that major hospitals in Mexico have fewer numbers of new cases of suspected or confirmed A/H1N1 swine flu. That is considered a favorable trend, even as there are now 92 confirmed cases worldwide, in at least six other countries.

The Associated Press quoted Mexican Minister of Health Secretary Jose Angel Cordova, as saying that the number of new cases of confirmed or suspected swine flu at “Mexico’s largest government hospitals” had declined in the past three days, falling from 141 on Saturday to 119 on Sunday and 110 Monday.


INFLUENZA UDPATE: Swine Flu Now “A Public Health Emergency of International Concern”

More confirmed influenza cases in the United States

This Dark Daily follows up the special ALERT distributed last Friday afternoon about the emergence of a new strain of influenza in Mexico. The following day, Saturday, the World Health Organization  issued a statement declaring that the new strain of flu virus is “a public health emergency of international concern.” Medical laboratories should be informed about these events.

In the United States, on Sunday the Department of Health and Human Services declared a public health emergency in the United States. At the same time, Homeland Security Secretary Janet Napolitano downplayed this declaration, characterizing it as a “standard operating procedure.” The clearer truth of the situation was acknowledged by Richard Besser, M.D. Acting Chief of the Centers for Disease Control and Prevention, who told the press that “We do think this will continue to spread but we are taking aggressive actions to minimize the impact on people’s health.”

These are just two of the many remarkable developments. In the 48 hours since the first Dark Daily ALERT, the running total of deaths attributed to the A/H1N1 influenza virus in Mexico has climbed regularly, as has the total number of confirmed cases. For example, at one point on Sunday, the Associated Press  said that Mexican health authorities were reporting 1,614 suspected cases of swine flu that included 103 deaths. It is likely that, whenever you read this Dark Daily e-briefing, there will news of a greater number of swine flu cases in Mexico.


IMPORTANT ALERT for All Clinical Laboratories: New Influenza-Like Disease in Mexico Is Being Watched by Health Agencies Worldwide

Similar cases reported in the California counties of San Diego and Imperial, as well as in San Antonio, Texas

Mexico is dealing with what experts believe to be a new strain of influenza which has a combination of genes not previously identified with either human or swine flu. However, this emerging strain-described as A/H1N1 in news reports-seems to be most similar to a flu virus circulating in pigs since 1999. A troubling number of deaths connected to this virus have caught the attention of Mexican health authorities, along with the World Health Organization (WHO), health officials in Canada, and, as of this afternoon, the Centers for Disease Control and Infection (CDC).

Dark Daily is the first laboratory news resource to alert medical laboratories, pathology laboratories and experts in laboratory medicine to this situation, which has only caught the attention of news outlets in recent hours. In particular, clinical laboratories in states bordering Mexico, including Texas, New Mexico, Arizona, and California, will want to be particularly vigilant.