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Former Wall Street Journal Reporter John Carreyrou Reveals Ex-Theranos CLIA Laboratory Director and Pathologist Was Main Source for 2015 Investigation into Theranos

WSJ reporter affirms that the pathologist was his “first and most important source” in confirming the problems at the now-defunct medical lab testing company

During the federal fraud trial of Theranos Founder and former-CEO Elizabeth Holmes, no one has spent more days on the witness stand than ex-Theranos Laboratory Director Adam Rosendorff, MD, the pathologist who testified for the prosecution that he repeatedly warned Holmes about problems with Theranos’ flawed Edison blood-testing device.

Dark Daily’s previous ebrief on the ongoing Holmes’ fraud trial reported that Rosendorff, who is board certified in clinical pathology, had testified, “I told her that the potassium was unreliable, the sodium was unreliable, the glucose was unreliable, [and] explained why. She was very nervous. She was not her usual composed self. She was trembling a bit, her knee was tapping, her voice was breaking up. She was clearly upset.”

It should come as no surprise that in response Holmes’ lawyers attempted to paint Rosendorff as an “incompetent” lab director with a resume littered with failures at other biotech companies. According to court documents, Holmes faces 10 counts of wire fraud and two counts of conspiracy to commit wire fraud for allegedly misleading investors, clinical laboratories, patients, and healthcare providers about Theranos’ proprietary blood-testing technology.

But the many clinical laboratory professionals closely watching the Holmes trial will be equally interested to learn that outside of the courtroom former Wall Street Journal (WSJ) reporter John Carreyrou confirmed on Twitter that Rosendorff was the main source for his 2015 investigative reporting—which first called into question Theranos’ claim that it could run more than 200 blood tests using a finger-prick of blood—as well as for his subsequent book, “Bad Blood: Secrets and Lies in a Silicon Valley Startup.”

Carreyrou Declares Ex-Theranos Lab Director Adam Rosendorff a Hero

“So, I’ve been fielding queries from reporters asking me to confirm that former Theranos lab director Adam Rosendorff, who is currently testifying at Elizabeth Holmes’ trial, was my source. I can now confirm it. Alan Beam = Adam Rosendorff,” Carreyrou tweeted.

“I’ll add this: Adam was my first and most important source. Without him, I wouldn’t have been able to break the Theranos story. Hats off to his courage and integrity. He’s one of the real heroes of this story,” Carreyrou added in a subsequent Tweet.

Inside the San Jose, Calif., courtroom, pathologist Rosendorff took centerstage, completing six days on the witness stand as Holmes’ defense attorney Lance Wade, JD, sought to undermine Rosendorff’s earlier testimony for the prosecution and question his competence as a laboratory leader.

John Carreyrou

Former Wall Street Journal reporter John Carreyrou (above) has revealed via Twitter that ex-Theranos laboratory director Adam Rosendorff, MD, was the “first and most important source” for his 2015 investigative reporting on Theranos. “Hats off to his courage and integrity,” Carreyrou tweeted. “He’s one of the real heroes of this story,” (Photo copyright: Penguin Random House Speakers Bureau.)

Rosendorff Testifies About Another CMS Investigation at Lab Where He is Medical Director

In “Former Theranos Lab Director Questioned about Faulty Lab Tests at Current Employer,” the WSJ reported that, in an attempt to undermine Rosendorff’s credibility, Holmes’ lawyers questioned him about another lab that was investigated by the Centers for Medicare and Medicaid Services (CMS) while he was lab director.

Rosendorff acknowledged during cross examination that he risked losing his license as a lab director after the CMS inspectors uncovered testing deficiencies at PerkinElmer’s Valencia (California) Branch Laboratory as well, where Rosendorff currently serves as Laboratory and Medical Director.

According to the WSJ, Rosendorff testified that most of the CMS inspection involved reviewing documents. During cross examination, it was revealed that the same CMS inspectors who investigated Theranos also conducted the PerkinElmer lab investigation.

Defense attorneys also had hoped to question Rosendorff about his previous work at uBiome Inc., a startup that was the target of a 2019 federal probe into its lab test billing practices, CNBC reported.

The Mercury News reported that during an October 5 hearing to determine the extent to which Holmes’ legal team could cross examine Rosendorff about his past employment, Wade told US District Judge Edward Davila that Rosendorff had a failed record as a lab leader. The Holmes defense lawyer alleged a link between “unreliable test results” at the biotechnology company Rosendorff went to after leaving Theranos and claimed that Rosendorff’s work at PerkinElmer resulted in the CMS notice of “serious deficiencies” at the lab.

“[Rosendorff] pointed the finger at many other people, including my client,” Wade told Davila. “He appears to almost never have competently done his job. He was incompetent at Theranos, too, and that is the reason many of the failures happened. He’s the person who’s ultimately responsible in the laboratory,” he added.

Nevertheless, Judge Davila prohibited questions regarding Rosendorff’s employment at uBiome and limited the scope of questions about his current role at PerkinElmer.

Courtroom graphic of Elizabeth Holmes' trial

The graphic above depicts Holmes’ defense attorney Lance Wade, JD, cross examining former Theranos CLIA laboratory director Adam Rosendorff, MD. During his testimony, Rosendorff claimed he warned Holmes about the unreliability of Theranos’ Edison blood-testing device. Pathologists and clinical laboratory leaders will recall that Walgreens had contracted with Theranos to place testing devices in its in-store pharmacies. (Graphic copyright: The Wall Street Journal/Vicki Behringer.)

Holmes’ Attorneys Challenge Rosendorff’s Testimony During Cross Examination

After leaving Theranos, Rosendorff’s LinkedIn profile shows he served as Laboratory Director at San Francisco-based Invitae from December 2014 to September 2017 before moving to Millennium Health in San Diego as Medical Director from December 2017 to January 2021. He joined PerkinElmer in January.

The WSJ reported that Rosendorff’s ties to uBiome showed up in Theranos court records.

The WSJ also noted that during the multiday cross examination of Rosendorff, the Holmes defense team scored points by “pointing to contradictions in his testimony and challenging his assertions that he wanted to expose Theranos’ testing practices to the government.”

In making his point, Wade read aloud from a deposition Rosendorff gave during a separate case in which he claimed that Theranos did not have a greater number of anomalous test results than other labs where he had previously worked.

“And that’s 180 degrees from what you answered in your direct testimony,” Wade said to Rosendorff during cross examination.

“Yes, it seems to be different,” Rosendorff replied, but also noted that Theranos should have fewer errors than a lab with a much higher volume of tests.

Wade also introduced a November 2014 email in which Rosendorff told a colleague he knew of only one time when Theranos provided to a patient an obviously incorrect test result. Rosendorff had previously testified that he alerted Holmes on numerous occasions about his concerns with ongoing testing errors.

Wade also questioned whether Rosendorff had a financial motive for considering a whistleblower lawsuit against Theranos, pointing out that Rosendorff would be entitled to a portion of any damages recovered. Rosendorff responded that he did not have a profit motive in mind when he forwarded more than 150 Theranos emails to his personal account.

Former WSJ Reporter Carreyrou May Be Called to Testify

Clinical laboratory managers and pathologists will be fascinated with another twist that surfaced as this trial continued. Former WSJ reporter Carreyrou became personally intertwined with the Holmes’ trial after it came to light that the investigative reporter—whose podcast “Bad Blood: The Final Chapter” spotlights the ongoing fraud trial—is on Holmes’ potential witness list.

In “Elizabeth Holmes Accused of ‘Cynical Ruse’ to Harass ‘Bad Blood’ Author by Putting Him on Witness List,” The Mercury News reported that the former WSJ journalist had filed a motion in court on October 1 contending his inclusion on the witness list is an effort to stop him from attending the trial and reporting firsthand on proceedings.

The motion, The Mercury News reported, states that “Placing Carreyrou on the witness list was done in bad faith and was designed to harass him,” and calls his placement on the list “a cynical ruse” that violates Carreyrou’s First Amendment rights.

CNN reported that Carreyrou’s attorneys are asking that the exclusion order (which prevents some witnesses from being inside the courtroom during other witness testimonies) or the gag order (which allows witnesses to discuss their testimonies only with their attorneys) not be applied to Carreyrou.

For clinical laboratory scientists awaiting the next installment in the now six-week-old trial, former Safeway CEO Steven Burd (now founder and CEO of Burd Health) will continue his testimony on the failed partnership between the grocery store chain and Theranos.

The Theranos agreement with Safeway is not as well-known as the Theranos-Walgreens deal. This was another news story written by Carreyrou and published by the WSJ on Nov. 10, 2015, titled, “Safeway, Theranos Split after $350 Million Deal Fizzles.”

As part of that agreement, Safeway spent $350 million to remodel 800 of its grocery stores to have a patient service center (PCS) and laboratory space where the unproven Edison device would be used to perform the clinical laboratory tests.

The testimony in this next phase of trial about the Safeway agreement with Theranos, and Holmes’ role in convincing the Safeway executive team to invest a third of a billion dollars to build 800 PSCs and lab spaces in 800 stores, should be as interesting as the witness testimony given earlier in this trial. 

Andrea Downing Peck

Related Information

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Former Theranos Lab Director Questioned about Faulty Lab Tests at Current Employer

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United States v. Elizabeth A. Holmes, et al. 18-CR-00258-EJD

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Former Theranos Lab Director and Staff Testify in Ongoing Elizabeth Holmes Fraud Trial That They Voiced Concerns about Reliability and Accuracy of Edison Blood-Testing Device

Text Messages Between Theranos Founder Elizabeth Holmes and Ex-Boyfriend Ramesh “Sunny” Balwani Grab Headlines in Early Days of Fraud Trial

Theranos Founder and Former CEO Elizabeth Holmes’ Federal Criminal Fraud Trial Finally Is Under Way in California

Safeway, Theranos Split after $350 Million Deal Fizzles

Text Messages Between Theranos Founder Elizabeth Holmes and Ex-Boyfriend Ramesh “Sunny” Balwani Grab Headlines in Early Days of Fraud Trial

Romantic musings between the now-defunct Theranos’ CEO and COO may be introduced to undercut Holmes’ claims of ‘intimate partner abuse’

Medical laboratory professionals did not have to wait long for the first prosecution bombshell to explode during the opening week of the federal criminal fraud trial of former Theranos CEO Elizabeth Holmes.

In court filings leading up to the September 8 trial in San Jose, Calif., Holmes’ defense team revealed plans to claim “intimate partner abuse” by Holmes’ then boyfriend, Theranos Chief Operating Officer Ramesh “Sunny” Balwani. The plan was for Holmes to testify that Balwani threw “sharp” objects at her and controlled how she ate and dressed, impacting her “state of mind” at the time of the alleged crimes.

But prosecutors countered that claim by releasing six pages of text messages between the former couple, which took place between May 2015 and July 2015, as Theranos became the target of whistleblower accusations and a company employee who began secretly speaking to the Wall Street Journal (WSJ). Later that year, the WSJ published an investigative report that brought to light questions about Theranos’ blood-testing technology and the faulty clinical laboratory test results it reported to physicians and patients.

Holmes and Balwani kept their relationship hidden from the public, but their private text messages reveal intimate exchanges that likely will be introduced by prosecutors to undercut Holmes’ claims of abuse.

Within the 164 text messages were these exchanges:

  • “You are breeze in desert for me” [Holmes]
  • “My water” [Holmes]
  • “And ocean” [Holmes]
  • “Meant to be only together tiger” [Holmes]
  • “Madly in love with you and your strength” [Holmes later that day]

The following day:

  • “On route to dinner. Missing you” [Holmes]
  • “Missing you too” [Balwani]
  • “You more” [Holmes]

Balwani then turned his attention to the whistleblower within Theranos:

  • “I’m narrowing this down in CLIA. Down to 5 people. Will nail this mother [explicative omitted]” [Balwani]
  •  “Who do u think” [Holmes]
  • “Now we have legal grounds” [Holmes]
  • “Yes” [Balwani]

Later Holmes texted:

  • “Feel like the luckiest person in the world BC I have you” [Holmes]
  • “We will come up with good responses to the questions and we will turn this around” [Balwani]
  • “Love” [Balwani]
  • “Transcend” [Holmes]
  • “We will” [Balwani]

The following month:

  • “Onboard. Love.” [Balwani]
  • “Taking off baby” [Balwani]
  •  “Missing you” [Holmes]
  • “Missing you too baby. Just arrived at the office. Will prepare” [Balwani]
  • “Xxx” [Holmes]
Elizabeth Holmes and Ramesh Balwani

Prosecutors in the federal fraud trial of former Theranos CEO Elizabeth Holmes (above, left) have included in a court filing 180 text messages sent between Holmes and former Theranos COO Ramesh “Sunny” Balwani (above, right) that reveal their romantic involvement and efforts to unearth the whistleblower within the failed blood-testing company. (Photo copyright: Yichuan Cao/NurPhoto via Getty Images [Holmes], Justin Sullivan/Getty Images [Balwani].
) 

Does Affection Rule Out Abuse?

In San Francisco, KPIX 5 television reported that legal experts predict the texts may not have the impact in the trial that outside observers expect, since, they said, expressions of affection do not rule out the possibility of an abusive relationship, which is expected to be one aspect of Holmes’ defense strategy.

Holmes, 37, who according to court documents faces 10 counts of wire fraud and two counts of conspiracy to commit wire fraud, is alleged to have misled investors, clinical laboratories, patients, and healthcare providers about Theranos’ proprietary blood-testing technology, which Holmes claimed could perform hundreds of medical laboratory tests using only a finger-prick of blood. If convicted, Holmes could face up to 20 years in prison, fines, and payment of restitution. She has pleaded not guilty.

Testimony of Theranos’ Corporate Controller

The prosecution opened the trial with questioning of Theranos’ longtime corporate controller Danise Spivey Yam. According to The Wall Street Journal, Yam testified she provided revenue projections to a company hired to value Theranos stock that ranged from $50 million in 2013 to nearly $132 million in 2016. Those numbers were much more modest than company projections of $140 million in revenue in 2014 and $990 million in 2015, which were given to investors.

“Do you have any idea where that number came from?” Assistant US Attorney Robert Leach asked Yam.

“No,” Yam replied, adding that she hadn’t helped prepare it.

Former Theranos employee Erika Cheung, who according to court testimony worked in the company’s laboratory testing blood samples, testified that she left Theranos after six months because of concerns over Theranos’ blood-testing practices and data manipulation when machines failed quality tests.

Cheung ultimately alerted federal regulators to the company’s failure to meet industry standards and expressed her concerns about Theranos’ Edison mini-blood-lab machine.

“You’d have about the same luck flipping a coin as to whether your results were right or wrong,” Cheung testified about the accuracy of the Edison, CNBC reported. “It was concerning to see this degree of failure; this was not typical for a normal lab.”

After leaving Theranos, Cheung co-founded the nonprofit Ethics in Entrepreneurship.

During cross examination, CNBC noted that one of Holmes’ defense attorneys highlighted the professional qualifications of Theranos lab directors and other scientists at Theranos, including 52 scientists with PhDs and 10 medical doctors. He also noted that the validation reports for assays that Cheung had testified were problematic had been approved for lab use by a lab director and vice president, not Holmes.

With more than 200 witnesses expected to testify, the ongoing Holmes fraud trial is estimated to last three to six months. Pathologists and clinical laboratory scientists who are following the Theranos fraud trial with keen interest can look forward to more Dark Daily coverage. Click here to read our previous coverage of the Holmes/Theranos medical laboratory fraud saga.

Andrea Downing Peck

Related Information

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Theranos Whistleblower Testifies Blood-Test Machines Were about as Accurate as a Coin Toss

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Court documents show Holmes’ defense strategy includes accusing ex-boyfriend and former COO Balwani of ‘intimate partner abuse’ that impacted her ‘state of mind’

It has started! The long-awaited criminal trial of former Theranos CEO Elizabeth Holmes is underway in a federal courthouse in Silicon Valley. Across the profession of medical laboratory medicine, there is keen interest in the story of Holmes and her now-defunct clinical laboratory company Theranos.

This next chapter in the drama began on September 8 with opening arguments. Federal prosecutors came out strong, claiming Holmes was “a manipulative fraudster who duped investors and patients alike and knew the whole time that she was hoodwinking them,” according to NPR.

“This is a case about fraud, about lying, and cheating to get money,” said Assistant US Attorney Robert Leach, NPR reported. “It’s a crime on Main Street, and it’s a crime in Silicon Valley,” he added.

Not surprisingly, Holmes’ defense team had a different take, claiming Holmes was simply “a hardworking, young startup executive who believed in the mission of the company, only to see it buckle in the face of business obstacles,” NPR reported. “They argued that she placed blind faith in the No. 2 executive at the company [Balwani] and overly trusted lab directors, who the defense team says were legally responsible for how the labs were run.”

Holmes Claims Abuse at the Hands of Former Theranos COO Balwani

Many pathologists and clinical laboratory managers are ready to watch and learn what unfolds in the opening stages of Holmes’ long-delayed federal criminal fraud trial. During the jury selection process, recently unsealed court documents showed that Holmes’ defense planned to include claims she was abused by her then boyfriend, Theranos Chief Operating Officer Ramesh Balwani.

This surprising development adds yet another twist to the tale of the disgraced Silicon Valley executive and her defunct clinical laboratory testing company.

The hype surrounding the once-high flying startup, which in 2015 reached a peak valuation of $9 billion, began unraveling that same year when a Wall Street Journal (WSJ) investigation exposed the company’s alleged deceptions and questionable practices related to its finger-prick blood-testing technology.

Fast-forward six years—Theranos is now gone but its top executive continues to make headlines, not as a laboratory science wunderkind, but as a criminal defendant.

Holmes, 37, has pleaded not guilty to all charges. Her former consort and ex-Theranos COO Ramesh Balwani also pleaded not guilty to all charges. He will be tried separately from Holmes.

Elizabeth Holmes and her husband William Evans

Elizabeth Holmes, founder and former CEO of defunct clinical laboratory testing company Theranos, is seen leaving the Robert F. Peckham US Courthouse with husband William Evans following opening arguments in her federal trial on September 8. (Photo copyright: Reuters/Peter DaSilva.)

Dozens of Potential Jurors Removed for Alleged Bias

On August 31, in-person questioning of prospective jurors began in Holmes’ federal fraud trial in San Jose, California. The process did not go well. As CNBC reported, dozens of potential jurors were removed from the jury pool due to potential bias in the case.

“Thirty to forty of the remaining jurors have consumed substantial, and I mean lengthy extrajudicial material, about the case and about the defendant,” defense attorney Kevin Downey, JD of Washington, D.C.-based Williams and Connolly, LLP, told Judge Edward Davila, CNBC reported. “We’re very vulnerable to any of the jurors commenting in some ways as either the court or lawyers conduct voir dire about the content of the media they’ve seen.”

Voir dire is the legal term for preliminary examinations of jurors, which in this initial screening was done by reviewing potential juror questionnaires.

Holmes’ defense attorneys, according to CNBC, previously expressed concerns about “inflammatory” media coverage of the case. However, Assistant US Attorney Jeffrey Schenk maintained, “Less than half of the individuals that filled out the questionnaire had prior exposure to Holmes and Balwani. One juror saying something during the voir dire process that could be overheard is a risk in every court case,” CNBC reported.

Holmes Claims ‘Mental Condition Bearing on Guilt’

A report by the Independent notes that newly unsealed court documents which were first reported by NPR reveal that Holmes will mount a defense that includes claims of “intimate partner abuse” by Balwani, 56, during their past relationship.

 “The documents show that Ms. Holmes will describe how Mr. Balwani controlled what she ate and drank, how she dressed, and who she spoke to, while also alleging he threw ‘sharp’ objects at her,” the Independent reported.

NPR reported that court documents indicate Holmes is likely to take the stand and testify at her trial. She will not be presenting an insanity defense but will put forth a “defense of a mental condition bearing on guilt” that was the result of partner abuse and that impacted her “state of mind” at the time of the alleged crimes.

Court documents filed by Balwani’s defense attorneys label Holmes’ allegations as “salacious and inflammatory.”

“In truth, Ms. Holmes’ allegations are deeply offensive to Mr. Balwani, devastating personally to him and highly and unfairly prejudicial to his defense of this case,” defense attorney Jeffrey Coopersmith, JD, Principle and founder of Coopersmith Law and Strategy, wrote in the filing.

The Theranos Saga Continues …

In “Former Theranos CEO Elizabeth Holmes Is Pregnant, Causing a Further Delay in Her Trial Date,” Dark Daily reported that Holmes’ trial had been delayed multiple times since she was first was indicted on 11 counts of wire fraud and conspiracy to commit wire fraud in 2018. The COVID-19 pandemic, and more recently Holmes’ pregnancy, delayed the start of her trial until August.

CNBC reported that Holmes gave birth on July 10, 2021, in Redwood, California. The baby’s father is William Evans, heir to the Evans Hotels chain in California, The Sun reported.

Balwani’s criminal fraud trial is scheduled to begin with jury selection on January 11, 2022. Both Holmes and Balwani face maximum penalties of 20 years in jail and a nearly $3 million fine, plus possible restitution if found guilty on all counts.

It is a rare thing for owners of a clinical laboratory company accused of fraud to come to trial and receive so much media attention. In the weeks leading up to the trial, medical laboratory managers and pathologists could read a wide variety of news stories about the impending trial and the legal strategies expected by the attorneys for both the plaintiffs and the defendants.

Thus, everyone interested in this trial and its outcome will likely have the equivalent of a front row seat because so many journalists are covering this trial.

Andrea Downing Peck

Related Information

Hot Startup Theranos Has Struggled with Its Blood-Testing Technology

Dozens of Potential Jurors in Elizabeth Holmes Trial Cut for Potential Bias

Case 5:18-cr-00258-EJD Document 973

Case 5:18-cr-00258-EJD Document 976

Elizabeth Holmes Claims Abuse by Ex-Boyfriend Who Controlled What She Ate in Theranos Fraud Trial Defense

Elizabeth Holmes Plans to Accuse Ex-Boyfriend of Abuse at Theranos Fraud Trial

Elizabeth Holmes Gives Birth as Fraud Theranos Fraud Trial Nears

Former Theranos CEO Elizabeth Holmes Is Pregnant, Causing a Further Delay in Her Trial Date

American Robotics Gets FAA Approval to Operate First Fully Automated Drone for Commercial Use ‘Beyond Visual Line of Sight’ Bringing Unmanned Delivery of Medical Supplies and Clinical Laboratory Specimens a Step Closer to Reality

Boston-based American Robotics is approved to operate its Scout unmanned aircraft in rural areas and below a certain altitude, achieving a milestone that may allow the industry to ‘truly take off’

Routine drone delivery of clinical laboratory specimens and medical supplies moved a step closer to reality with the Federal Aviation Administration’s (FAA) green light to American Robotics (AR) to operate its fully automated drones without on-site pilots or on-the-ground spotters.

The Massachusetts-based company becomes the first drone operator to receive an FAA Certificate of Waiver, allowing it to operate its unmanned aircraft “beyond the visual line of sight (BVLOS) of the remote pilot in command.”

According to a news release, “Prior waivers and certifications awarded by the FAA required visual observers (VOs) stationed along the flight path to keep eyes on the airspace at all times, or required other burdensome restrictions such as infrastructure masking. … With this approval, American Robotics’ Scout System is now the first drone technology allowed to continuously operate without this costly human requirement.”

The FAA is restricting American Robotics’ operations to specific rural areas and at altitudes below 400 feet, with a maximum takeoff weight of 20 pounds, The Hill reported. Nevertheless, should AR’s automated Scout System prove safe, pilotless drones may soon be delivering clinical laboratory specimens and supplies to remote areas as well as to more densely populated hospital systems.

The FAA’s Certificate of Waiver is effective until January 31, 2023.

A New Era of Drone Delivery for Hospitals and Clinical Laboratories

Even with the restrictions, the FAA’s decision moves the commercial drone industry ever closer to routine transport of medical laboratory specimens and medical supplies by unmanned aerial vehicles (UAV).

“With these approvals, American Robotics is ushering in a new era of widespread automated drone operations,” Reese Mozer, CEO and co-founder of American Robotics, said in the news release. “Decades’ worth of promise and projection are finally coming to fruition. We are proud to be the first company to meet the FAA’s comprehensive safety requirements, which had previously restricted the viability of drone use in the commercial sector.”

The Wall Street Journal (WSJ) reported that the FAA’s decision signals the agency’s “broader effort to authorize widespread flights by shifting away from case-by-case exemptions for specific vehicles performing specific tasks.” According to the WSJ, the FAA’s approval documents state that American Robotics’ proposed operations will provide the agency with “critical data for use in evaluating BVLOS [beyond the visual line of sight] operations from offsite locations.”

American Robotics Scout drone

Each American Robotics Scout drone (above) is stored within a weatherproof base station that enables autonomous charging, data processing, analysis, and data transmission. According to the news release, “Once installed in the field, all facets of Scout’s operation are automated, allowing this technology to gather and analyze ultra-high-resolution data multiple times per day for years without expensive human labor.” Clinical laboratory managers will want to watch for progress in using drones to deliver medical supplies. (Photo copyright: American Robotics.)

FAA Approval a ‘Game Changer’

In its quest to receive FAA approval, American Robotics completed a four-year testing program around its Scout line of UAV products. According to the company, Scout systems flew as many as 10 automated missions per day in 2020 for industrial and agricultural customers in multiple states capturing a variety of advanced data.

The Scout system addresses safety concerns by using acoustic detect-and-avoid technology to maintain a safe distance from other aircraft while also avoiding birds or other potential obstacles.

“The commercial drone industry is growing quickly and providing significant benefits to the American public, but enabling expanded operations beyond visual line of sight is critical for the industry to truly take off,” Lisa Ellman, JD, Partner at Hogan Lovells and Executive Director of the Commercial Drone Alliance, said in the news release.

“Automated beyond visual line of site operations are particularly important to opening the commercial sectors to the drone economy, including the agriculture and industrial verticals. Key to these operations is the use and FAA acceptance of new and innovative safety technologies, such as detect and avoid sensors and software-enabled automation.”

The agricultural and energy industries are seen as key beneficiaries of this latest FAA action. Lance Ruppert, Director of Agronomy Marketing and Technology at Growmark Inc., a leading US grower cooperative, calls the American Robotics’ approval a “game changer.”

“Our interest in American Robotics’ technology started with the desire to have a drone imagery solution that was reliable, scalable, and executed with minimal human resources,” Ruppert said in the news release. “This technology, along with the FAA approvals to operate it without humans on the ground, is key to making drones a widespread reality in our industry.”

Drone Delivery of Clinical Laboratory Specimens Worldwide

In, “UPS Expands Drone Delivery Service for Transporting Clinical Laboratory Specimens Across Healthcare Systems to Include Delivering Prescriptions from CVS Pharmacy to Customers’ Homes,” Dark Daily reported how the United Parcel Service (UPS) successfully delivered by air medical prescriptions from a CVS pharmacy to customers’ residences in Cary N.C. This was the next step in the package delivery company’s plan to become a major player in the use of drones in healthcare and it has major implications for clinical laboratories and pathology groups.

And past Dark Daily ebriefings reported on drone delivery of medical supplies being conducted in Virginia, North Carolina, Australia, Switzerland, and Rwanda. With potentially fully automated systems just around the corner, there’s no question the use of drones to transport critical medical supplies and biological specimens is poised for an amazing breakthrough.

While the FAA’s approval of the first fully automated commercial drone flights may not have an immediate impact on clinical laboratories, the increasing use of commercial drones brings drone transportation of lab specimens and other medical supplies one step closer to reality.

—Andrea Downing Peck

Related Information

American Robotics Becomes First Company Approved by FAA to Operate Automated Drones without Human Operators on Site

FAA Decision: Jan. 14, 2021

FAA Approves First Fully Automated Commercial Drone Flights

US Department of Transportation FAA Certificate of Waiver

The FAA Just Greenlit This Drone to Fly Autonomously without a Human Nearby

FAA Approves First Fully Automated Commercial Drone Flights

UPS Expands Drone Delivery Service for Transporting Clinical Laboratory Specimens Across Healthcare Systems to Include Delivering Prescriptions from CVS Pharmacy to Customers’ Homes

Consumer Genetic Testing Company 23andMe to Merge with Sir Richard Branson’s VG Acquisition Corp. and Go Public

The merger is expected to boost investment in 23andMe’s consumer health and therapeutics businesses

After years of spectacular growth, the popularity of direct-to-consumer (DTC) genetic testing is beginning to wane. Nevertheless, opportunities still exist in the DTC genetic testing market for visionaries with funds to invest.

One such visionary is billionaire Richard Branson, founder of the multinational venture capital conglomerate Virgin Group (VG). Branson’s VG Acquisition Corp. (NYSE:VGAC), a special purpose acquisition company (SPAC), announced it is merging with 23andMe of Sunnyvale, Calif., to create a publicly-traded company with the New York Stock Exchange ticker symbol ME.  

In a VG press release, Branson states his reason for the merger. “Of the hundreds of companies we reviewed for our SPAC, 23andMe stands head and shoulders above the rest,” he said. “As an early investor, I have seen 23andMe develop into a company with enormous growth potential. Driven by [CEO Anne Wojcicki’s] vision to empower consumers, and with our support, I’m excited to see 23andMe make a positive difference to many more people’s lives.”

According to a 23andMe press release, the deal values the company at approximately $3.5 billion and will net the consumer genetics and research company as much as $759 million in additional cash. Wojcicki and Branson each invested $25 million themselves as part of the $250 million fund to take the company public.

CEO Anne Wojcicki headshot
“As a fellow industry disruptor as well as an early investor in 23andMe, we are thrilled to partner with Sir Richard Branson and VG Acquisition Corp. as we approach the next phase of our business, which will create new opportunities to revolutionize personalized healthcare and medicine,” 23andMe co-founder and CEO Anne Wojcicki (above) said in the press release. “We have always believed that healthcare needs to be driven by the consumer, and we have a huge opportunity to help personalize the entire experience at scale, allowing individuals to be more proactive about their health and wellness. Through a genetics-based approach, we fundamentally believe we can transform the continuum of healthcare.” (Photo copyright: Inc. magazine.)

Participation in Research Key to Future of DTC Genetics Testing

Though DTC genetic testing kit sales have slowed in recent years for both 23andMe and rival Ancestry, Wojcicki believes the company’s database of 10 million customers—with 80% of customers agreeing to participate in research—is the key to its future.

“We have always seen health as a much bigger opportunity” than genealogy, Wojcicki told The Wall Street Journal (WSJ).

According to the WSJ, 23andMe customers fill out more than 30,000 surveys each day on health and related issues. With that information, the company has determined its database includes 1.7 million people with high cholesterol, nearly 1.6 million with depression and 539,000 with Type 2 diabetes, information that is highly valued by medical researchers and those running clinical trials.

Personalizing Healthcare through DTC Genetic Testing

Wojcicki expects the merger will propel the consumer DNA-testing company into personalized medicine and therapeutics. “We have always believed that healthcare needs to be driven by the consumer, and we have a huge opportunity to help personalize the entire experience at scale, allowing individuals to be more proactive about their health and wellness,” Wojcicki said in a statement. “Through a genetics-based approach, we fundamentally believe we can transform the continuum of healthcare.”

In August 2020, the US Food and Drug Administration “granted 23andMe a 510(k) clearance for a pharmacogenetics report on two medications—Clopidogrel, prescribed for certain heart conditions, and Citalopram, which is prescribed for depression,” 23andMe announced in a blog post.

“This impactful pharmacogenetics information can now be delivered without the need for confirmatory testing, a testament to the clinical validity of 23andMe results,” said Kathy Hibbs, 23andMe Chief Legal and Regulatory Officer, in the blog post. “23andMe remains the only company with direct-to-consumer pharmacogenetic reports cleared by the FDA.”

23andMe’s trove of genetic data already has netted it a partnership with GlaxoSmithKline (GSK). According to a GSK press release, in 2018, the two companies signed a four-year research and development agreement. The collaboration targets novel medicines and potential cures using human genetics as the basis for discovery.

COVID-19 Boosts 23andMe’s Sales

During a joint interview with Branson in Bloomberg News about the merger, Wojcicki said, “COVID-19 has really opened up doors.” Now more than ever, she said, people are interested in preventative healthcare. “I’ve had this dream since 2003 that genetics would revolutionize healthcare and that’s really the era I see we can now usher in,” she added.

As 23andMe pushes further into personalized therapeutics, clinical laboratories and pathology groups would be wise to watch and see if this new entrant accelerates healthcare’s shift to the precision medicine model of personalized care.

—Andrea Downing Peck

Related Information:

23andMe to Merge with Virgin Group’s VG Acquisition Corp. to Become Publicly Traded Company Set to Revolutionize Personalized Healthcare and Therapeutic Development through Human Genetics

23andMe Go Public with Richard Branson Backed SPAC

GSK and 23andMe Sign Agreement to Leverage Genetic Insights for the Development of Novel Medicines

23andMe Lays Off 100 People, CEO Anne Wojcicki Explains Why

FDA Grants 23andMe Clearance to Offer Interpretive Drug Information for Two Medications

Fears over DNA Privacy as 23andMe Plans to Go Public in Deal with Richard Branson

23andMe to Go Public as $2.5 Billion Company via Branson Merger

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