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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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News Flash! New York Times Hits Quest Diagnostics for Erroneous Vitamin D Results!

Just days after The Dark Report and Dark Daily alerted the laboratory industry to systemic problems with “home brew” mass spectrometry Vitamin D testing at Quest Diagnostics Incorporated (NYSE:DGX) during a period starting in early 2007 and lasting into mid-2008, the New York Times has confirmed the essential details of this extraordinary story.

In the Thursday, January 8, 2009, edition of the New York Times, reporter Andrew Pollack wrote a story titled “Lab Acknowledges Problem with Vitamin D Test.” In balanced coverage, Pollack provided information about Quest Diagnostics’ acknowledgement that it had reported inaccurate results for what appears to be about a year and a half. He also quoted physicians on the various clinical issues associated with Vitamin D testing, Vitamin D therapy, and the role Vitamin D plays in various diseases.

The exact magnitude of the problem remains unknown, because Quest Diagnostics has neither disclosed the number of physicians who received letters about erroneous Vitamin D results reported on their patients, nor the number of patients for whom inaccurate Vitamin 25(OH) D test results were reported by Quest Diagnostics during the 2007-2008 time period.

However, competing laboratories in the New York metropolitan area have told The Dark Report and Dark Daily that thousands of physicians in this region received Vitamin D recall/retest letters from Quest Diagnostics. Most of these letters were sent in October 2008. Each physician may have had as few as a handful of patients to retest, or as many as several hundred. Thus, just in the New York region, it would not be unreasonable to estimate that tens of thousands of patients are involved in this Vitamin D retest program.

One clue to the total number of inaccurate results was provided in The New York Times story, which wrote that “Dr. Salameh [Wael A. Salameh, M.D., Medical Director, Endocrinology at Quest Nichols Institute in San Juan Capistrano, California] said the inaccurate results represented fewer than 10% of all the vitamin D tests done by the Quest from early 2007 to mid 2008. And even many of the possibly inaccurate results were probably accurate, he said, because Quest sent letters even if there was only a remote chance that the test was erroneous.”

Take Salameh’s statement that “fewer than 10% of all the Vitamin D tests” were inaccurate, and assume a 9% rate of inaccurate tests. Next, combine that with a rough estimate that Quest Diagnostics performed between 5 million and 7 million Vitamin D results during 2007-2008, and one comes up a possible range of between 450,000 to 630,000 inaccurate Vitamin D test results.

That’s a lot of patients-and a lot of doctors! Assume 10 patients per doctor, and that means Quest Diagnostics may have reported inaccurate Vitamin D results to between 45,000 and 63,000 doctors! If the real numbers approach these estimates of affected patients and referring physicians, then this is a laboratory failure without precedent.

How could something this troubling happen at the nation’s largest laboratory company? According to the New York Times, Salameh stated that “some materials used to calibrate test results were faulty.” Salameh also admitted that “four of Quest’s seven testing laboratories around the country did not follow proper procedures for some period of time.”

The January 12 issue of The Dark Report will have additional intelligence briefings on this unfolding story. Dark Daily readers interested in becoming a subscribing member to The Dark Report can act immediately with this link (or copy this URL and paste in your browser: http://www.darkreport.com/dark/subscribe.htm).

The current issue of The Dark Report (dated December 22, 2008) was the first public news reporting on Quest Diagnostics’ problems with Vitamin D testing. This issue has been distributed to existing subscribing members. Dark Daily readers can see the individual intelligence briefings by using this link (or pasting this URL in your browser: http://www.darkreport.com/dark/past.htm) For more information on Charter Memberships go here.

Dark Daily asks that anyone with knowledge of this remarkable story about inaccurate Vitamin D results and willing to share insights can contact editor Robert L. Michel in complete confidence at rmichel@darkreport.com or by dialing 512-264-7103.

Related Information:

Debut of ixlayer on Inc. 5000 List of Fastest Growing Businesses for 2023 Indicates a Dynamic Clinical Laboratory Test ‘Middleman’ Sector

Growth of the middleman company is a sign of increased credibility and acceptance among its client organizations

There’s a new category of player in the clinical laboratory testing industry. It is the “middleman” company. One high-profile example of a middleman company in diagnostics is the company ixlayer of San Francisco, which has a novel plan for growth.

The software developer provides cloud-based diagnostic testing platforms to retailers, health plans, and biopharma companies. Medical laboratory tests are not processed by ixlayer, however, but are instead sent to independent CLIA-certified clinical labs for completion and results reporting.

Thus, ixlayer acts as a third-party “middleman” in the lab testing chain.

Ixlayer recently debuted as number 1,418 on the 2023 Inc. 5000 list of fastest-growing private companies in the US, according to a company news release. Might this signal a dynamic and expanding clinical laboratory middleman sector?

There are a number of other established middleman companies doing this on the web as well, including:

Produced by Inc. Business Media, the Inc. 5000 list is based on data analysis of the fastest growing private businesses in the US. Ixlayer reportedly grew its 2023 revenue 100% year-over-year. 

Pouria Sanae

“To be selected for the Inc. 5000 list is an honor that validates the value we deliver while enabling greater access to care for all,” said Pouria Sanae (above), co-founder and CEO of ixlayer. “We’ve developed a platform that powers millions of diagnostic tests each year and serves as the backbone of thousands of health testing programs for trusted health brands, healthcare delivery organizations, payers, and life sciences companies. I’m excited about the future as we redefine and simplify the diagnostic laboratory testing ecosystem.” (Photo copyright: ixlayer.)

Ixlayer Works with Retailers, Insurers, Biopharma, and Clinical Labs

Ixlayer “facilitates” tests by working with industry partners and clinical laboratories, Managed Healthcare Executive explained.

One such relationship is with retailer CVS, Fierce Healthcare reported. Ixlayer provides the cloud-based diagnostics platform, at-home sample collection kits, and coordination of testing services for some of the pharmacy company’s at-home testing products. They include:

“With nearly 70% of medical decisions dependent on lab testing, regular diagnostic testing is a cornerstone of improving health and wellness,” Pouria Sanae, co-founder and CEO of ixlayer, told Drug Store News. “At-home testing enables people to proactively take control of their health, on their own schedule, in the privacy of their own home and on a regular basis. Our mission of creating a healthier world through more accessible, affordable, and easy health testing requires systemic changes and buy-in from key stakeholders and partners.”

Ixlayer directs specimens to independent labs that perform the tests and report results to consumers via an online portal.

“Founded in 2018, ixlayer initially focused on remote lab testing for Alzheimer’s disease patients. The company now offers thousands of white-labeled, at-home, and onsite health tests ranging from women’s wellness to sexually transmitted diseases and chronic condition management,” the news release notes.

“We’re thinking of it more from the perspective of: How do we infiltrate this infrastructure into our whole healthcare ecosystem? How do we let traditional providers run their programs the way they want to?” Alecia Pritchett, ixlayer Chief Growth Officer, told Managed Healthcare Executive.

Ixlayer “is not a lab,” Managed Healthcare Executive explained. “It describes itself as a platform. Instead of performing its own lab tests, it connects providers and retailers to accredited laboratory partners. Instead of sending out its own team of phlebotomists to collect blood samples, the company coordinates with mobile phlebotomy firms.”

“This comprehensive data visualization solution provides a more insightful analysis of testing performance data, empowering health plans, retailers, and biopharma organizations to monitor and manage progress in real-time effectively. With this actionable intelligence, decision-makers can focus on addressing gaps in care, accelerating access to critical drug studies, and promoting greater health equity to improve clinical and quality outcomes and economics across the healthcare ecosystem,” said David Yu, Chief Product Officer at ixlayer, in a news release.

Any Lab Test Now Also Makes Inc.’s 5000 List

Also making the 2023 Inc. 5000 list is Any Lab Test Now, an Alpharetta, Ga.-headquartered laboratory franchise that was founded in 2007. Any Lab Test Now is another form of middleman company which bills itself as the nation’s first direct access lab testing service with 200 locations. This is Any Lab Test Now’s second consecutive year on the list, according to a news release.

Unlike ixlayer, Any Lab Test Now’s business model features independently owned and operated locations around the US. Customers go online to choose a testing location, pay for tests, and schedule an appointment. Tests include:

At-Home Testing Market Growing

Allied Market Research reported that the global at-home testing market is expected to grow by about 10.5% annually from 2022 to 2031, when it will reach $45.5 billion.

Another middleman company offering at-home tests is Everlywell of Austin, Texas. Other middleman companies that enable consumers to order tests online and then visit a local clinical laboratory for specimen collection include Testing.com and Walk-In-Lab.com.

Ever since the COVID-19 pandemic, demand for at-home sample collection testing has grown steadily. Dark Daily has covered this in numerous ebriefs. That middleman companies are showing up on the Inc. 5000 list of fastest growing companies indicates that the middleman sector of the clinical laboratory testing industry is growing as well.

—Donna Marie Pocius

Related Information:

ixlayer Joins the Inc. 5000 List of Fastest Growing Companies in America

2023 Inc. 5000 List Company Profile: ixlayer

Health Tech Startup ixlayer Partners with CVS on Home Health Tests

ixlayer Enhances At-Home Diagnostic Health Testing Platform with Cutting-Edge AI and Data Visualization

Any Lab Test Now Lands on Prestigious Inc. 5000 for Second Consecutive Year

What’s Next for At-home Diagnostic Testing: Four Trends to Watch in 2024

Allied Market Research: Home Testing Market

Federal Prosecutors Add a 12th Felony Fraud Charge in Latest Criminal Indictment Against Theranos Founder Elizabeth Holmes

Holmes’ lawyers maintain the former CEO of Theranos has not waived right to be charged by indictment and therefore argue the added charge is ‘unconstitutional’ and should be dismissed

Clinical laboratory leaders needing a break from nonstop coronavirus pandemic news will be interested to learn a familiar name is again making headlines. Disgraced Theranos founder Elizabeth Holmes—who went from paper billionaire to criminal defendant—is now facing a 12th felony fraud charge, with the additional count tied to a patient’s blood-test result.

Holmes founded the blood testing company in 2003 after dropping out of Stanford University. Though Theranos reached a peak valuation of $9 billion in 2015, according to Investopedia its unicorn-startup status began unraveling that same year when a Wall Street Journal (WSJ) investigation exposed the company’s massive deceptions and questionable practices related to its finger-prick blood-testing technology.

Holmes and codefendant Ramesh “Sunny” Balwani, former Theranos President and Chief Operating Officer, claimed Theranos had developed a medical technology that could  run thousands of clinical laboratory tests using a finger-prick blood test that would return results in two hours and at a price that was 50% of Medicare’s fees for lab tests.

As Dark Daily previously reported in “Previously High-Flying Theranos Provides Clinical Laboratories and Pathology Groups with Valuable Lesson on How Quickly Consumer Trust Can Be Lost,” the company was brought to the edge of bankruptcy in the aftermath of a fraud settlement with the Securities and Exchange Commission,

sanctions from the Centers for Medicare and Medicaid Services, investor lawsuits, consumer lawsuits, and a settlement with Walgreens over claims about Theranos’ Edison portable blood analyzer, CNBC reported. Theranos ceased operations in September 2018.

Elizabeth Holmes is entering the Northern District of California courthouse with attorneys Kevin Downey and Lance Wade
Elizabeth Holmes is seen above entering the Northern District of California courthouse with attorneys Kevin Downey (left) and Lance Wade (right) of the law firm Williams and Connolly. (Photo copyright: Jason Doiy/ALM)

The 12th Felony Charge Against Elizabeth Holmes

Earlier in 2018, David L. Anderson, US Attorney for the Northern District of California indicted Holmes and Balwani on 11 counts of wire fraud and conspiracy to commit wire fraud.

Now, an additional wire fraud charge has been added to that list. The 12th felony charge was included in Superseding Information federal prosecutors filed with the court on May 8. Superseding Information is a charging document that does not require a grand jury proceeding.

In the filing, the latest allegation of fraud is alleged to have occurred on October 12, 2015, in the states of California and Arizona and is described as a “telephone call from Patient B.B. to Theranos regarding laboratory blood test results.”

The Superseding Information states: “Knowing that the accuracy and reliability of Theranos test results was questionable and suspect, Holmes and Balwani oversaw the electronic wiring of test results to patients, including persons known to the Attorney for the United States as Patients B.B, E.T., and M.E. These wires … travelled between one state and another.”

The amended charging document also more than doubles the length of time the pair are alleged to have conspired to defraud investors, adds additional categories of alleged victims, and revises the dates of two of the other prior wire fraud charges, changing them from 2014 to 2015.

“In particular, Holmes and Balwani knew that Theranos was not capable of consistently producing accurate and reliable results for certain blood tests, including but not limited to bicarbonate, calcium, chloride, cholesterol/HDL/LDL, gonorrhea, glucose, HbA1c, hCG, HIV, LDH, potassium, PSA, PT/INR, sodium, testosterone, TSH, vitamin D (25-OH), and all assays conducted on Theranos’ TSPU [Theranos Sample Processing Unit] version 3.5, including estradiol, prolactin, SHBG, thyroxine (T4/free T4), triiodothyronine, and vitamin B-12,” the Superseding Information states.

According to Law.com, Holmes’ lawyers at Williams and Connolly responded by filing a motion to dismiss the Superseding Information. Because grand jury proceedings have been suspended in the Northern District of California since mid-March due to COVID-19, they argue that Holmes, who hasn’t waived the right to be charged by grand jury indictment, is unable to be arraigned. They maintain the prosecutors’ actions violate her rights under the US Constitution and Federal Rules of Criminal Procedure Rule 7, which requires crimes punishable by a prison sentence of more than a year to be charged by indictment unless the defendant waives that right.

“Because Ms. Holmes does not waive prosecution by indictment, convening an arraignment on this information would be pointless and a waste of the Court’s time because no arraignment could actually occur,” her lawyers wrote in their motion. “The Court should dismiss this unconstitutional information without scheduling an arraignment.”

On May 26, prosecutors filed their opposition to the defendants’ motion to dismiss. They maintained that US District Judge Edward Davila should either deny the defense request outright or hold off ruling until a “reasonable time after the Court lifts the suspension of grand jury hearings.”

They wrote, “Defendants’ claim that an information must be ‘dismissed immediately’ because it is not the constitutionally required indictment proves too much,” adding, “Criminal charges are initiated all the time through preliminary proceedings like a complaint or an information. They are not ‘patently unconstitutional merely because a defendant has indicated she will not waive her right to be prosecuted by indictment.”

COVID-19 Delays Court Proceedings

Holmes’ trial originally was set to begin in August, but the COVID-19 pandemic has resulted in the case being postponed to October 27, reported CNBC. According to Davila, “We’re in unchartered waters and unchartered territories. We need to make sure the environment is safe for all parties, including the jury that’s called to hear the matter.”

The Theranos scandal continues to serve as a reminder to clinical laboratory leaders

and pathology groups that questionable or deceptive business practices eventually will draw the attention of federal regulators, prosecutors, and consumers, and that the penalty for fraud can be severe. The frustration for medical laboratory professionals and pathologists is that it generally takes years for federal investigators to bring charges against such frauds.

—Andrea Downing Peck

Related Information:

Theranos Case: Prosecutors Add a Criminal Fraud Charge Against Elizabeth Holmes

U.S. v. Elizabeth A. Holmes, et al. Superseding Information

Elizabeth Holmes’ Lawyers Object to Government’s Decision to Amend Charge by Information, Rather than Indictment

Hot Startup Theranos Has Struggled with its Blood-Test Technology

New Criminal Charge Against Theranos Founder Elizabeth Holmes Called ‘Patently Unconstitutional’

Theranos Founder Elizabeth Holmes’ Trial Delayed, Feds Plan to Add Charges

Elizabeth Holmes’ Criminal Trial Delayed Due to Coronavirus

U.S. vs. Elizabeth A. Holmes and Ramesh “Sunny” Balwani

U.S. v. Elizabeth Holmes, et al.

United States’ Opposition to Defendants’ Motion to Dismiss

Theranos, Walgreens Reportedly Reach a Deal to Settle Lawsuit for Under $30 Million

Theranos, CEO Holmes, and Former President Balwani Charged with Massive Fraud

Previously High Flying Theranos Provides Clinical Laboratories and Pathology Groups with Valuable Lesson on How Quickly Consumer Trust Can Be Lost

Canadian Scientists and Medical Researchers Urge Health Canada to Regulate Laboratory-developed Tests

Lack of regulations and quality management jeopardizes the quality and safety of LDTs, claim experts in clinical laboratory medicine in a commentary to Canadian policymakers

Health Canada is the latest government healthcare organization under pressure to enact legislation that regulates laboratory-developed tests (LDTs). In a public commentary, several members of the Institute of Health Policy, Management and Evaluation (IHPME) at the University of Toronto in Ontario, urged Canadian lawmakers to follow the European Union’s lead and find ways to monitor LDTs in Canada.

The IHPME members published their comments in the Canadian Medical Association Journal (CMAJ), a peer-reviewed journal owned by Joule Inc., a subsidiary of the Canadian Medical Association. In it, they claim “recent expansion of the molecular diagnostics industry has revealed weaknesses in Canada’s regulatory system for laboratory-developed tests, which are not subject to statutory regulations on medical devices.”

For pathologists and clinical laboratory professionals in both Canada and the United States, these recent actions show the concerns many experts have as they watch the explosive growth in the use of laboratory-developed tests in both countries. In many ways, the swift advances in molecular and genetic diagnostics is outrunning the ability of government regulators to keep pace with use of LDTs in clinical care settings.

In their commentary in CMAJ, the IHPME members also claim the review and evaluation of LDTs in Canada is inconsistent. Some LDTs they say, may endure stringent assessments and have endorsements by clinical guidelines or findings that are published in scientific journals. Other LDTs, however, may have no analysis at all.

In addition, the IHPME members point out that there is no national registry kept of LDTs. They theorize that a lack of proper regulation, controls, and quality management “has potentially jeopardized the delivery of quality, safe, timely, and appropriate care.”

The researchers calling on Health Canada to address these issues include:

  • Kelly Holloway, PhD, Research scientist at University of Toronto;
  • Fiona A. Miller, PhD, Professor of Health Policy and IHPME Chair in Health Management Strategies;
  • François Rousseau, PhD, Professor, Department of Molecular Biology, Medical Biochemistry and Pathology, Faculty of Medicine, Laval University, Quebec;
  • Alberto Gutierrez, PhD, Partner, NDA Partners LLC, former Director, Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health (CDRH);
  • Stuart Hogarth, PhD, Lecturer in Sociology of Science and Technology, University of Cambridge, Cambridge, UK.
During an exclusive presentation offered by The Dark Report (Dark Daily’s sister publication) in 2015, Alberto Gutierrez, PhD (above), who at that time was Director, Office of In Vitro Diagnostics and Radiological Health at the FDA, said, “LDTs are an area that will be difficult to regulate. There is a broad set of tests. Some of the LDTs are very good. Some of them require a lot of expertise from the pathologists and some of them don’t. Regulating LDTs in a way that makes sense and that does not disrupt what’s going on [in clinical laboratories] is going to be difficult.” (Photo copyright: FDA.)

Canadian Scientists Call on Health Canada to Take the Lead on Regulating LDTs

In the US, the FDA has been making moves to regulate LDTs since 2010, with much opposition from clinical laboratories and In Vitro Diagnostic (IVD) manufacturers. The FDA describes LDTs as internally designed clinical laboratory tests that are developed, manufactured, and used within a single laboratory. They have not undergone government regulatory review, can be simple or complex, and can be utilized to detect a variety of analytes.

Health Canada is the name of a department that falls under the purview of the Minister of Health and is part of Canada’s Health Portfolio. It is responsible for helping Canadians maintain and improve their health. Other agencies included in the Health Portfolio are:

According to the IHPME paper, however, Health Canada currently does not have a way to regulate LDTs, and no government agency in that country is responsible for the oversight of laboratory-developed tests. Only LDTs that are marketed as test kits are evaluated and reviewed by Health Canada. 

“The current laboratory regulatory system in Canada involves a mixture of public and private entities and operates with oversight from provincial governments, nongovernmental organizations, and professional societies,” the IHPME paper states, adding, “most provinces and territories rely on voluntary standards that are unevenly applied, with little auditing and systematic testing to ensure quality.”

The authors also note that the current lab regulations in Canada apply only to the operations of the medical laboratories themselves, encompassing such things as lab environments, personnel, accreditation, and quality control. They believe the loophole regarding LDTs needs to be addressed, and they urged Health Canada to “demonstrate leadership” by subjecting these tests to regulations that are currently applied to medical devices and pharmaceuticals.

Other Countries Regulate LDTs, though Not Without Controversy

In support of their call to action, IHPME researchers noted that Australia, the EU, and the US all have taken steps to regulate LDTs.

The Australian government began oversight of LDTs in 2010 by subjecting high-risk LDTs to external evaluation and then tracking them in a public registry.

An EU regulation, which was passed in 2017, will administer regulatory review of LDTs manufactured on an industrial scale, which targets commercial laboratories. The law exempts LDTs utilized within individual hospital laboratories and should be fully implemented by 2022.

Though on its radar since the 1990s, in 2010, the FDA officially announced its intent to regulate LDTs in the US. The agency released an initial draft approach for doing so starting in 2014, held a public workshop on the topic in 2015, and released a discussion paper in 2017. At this time, however, the FDA is not regulating LDTs, though the agency remains open to the possibility.

Dark Daily has reported extensively over the years on the development of LDTs and the controversy surrounding the FDA’s moves to regulate them.

According to the FDA website, problems with several high-risk LDTs have been identified, including:

  • Claims that are not adequately supported with evidence;
  • Lack of appropriate controls which may yield erroneous results; and
  • Falsification of data.

However, in “FDA Looks to Clamp Down on Laboratory-Developed Tests and Put an End to ‘Wild West of Medicine’: Might CLIA Problems at Theranos Support FDA’s Position?Dark Daily, May 4, 2016, Roger D. Klein, MD, JD, Chair of the Association for Molecular Pathology (AMP) Public Relations Committee, and Medical Director, Molecular Oncology at Cleveland Clinic, called a report released by the FDA in 2015 “mostly a hodgepodge of outlier assays.”

The FDA’s report, titled, “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests,” reviewed 20 case studies of LDTs for Lyme disease, ovarian cancer, whooping cough, fibromyalgia, prostate cancer, autism, breast cancer, melanoma, Vitamin D, and other conditions. The agency concluded that in many instances “patients have been demonstrably harmed or may have been harmed by tests that did not meet FDA requirements.”

Klein noted, however, that “The 20 tests described by FDA are mostly a hodgepodge of outlier assays including tests that were never offered, tests for which comparable FDA assays perform poorly, tests for poorly defined disorders with psychologic components, and use of an FDA-approved test off-label.” He continued, “That FDA could find only these dubious examples out of the many thousands of laboratory-developed procedures (LDPs) that benefit patients each day, calls into question the agency’s rationale for expanding its regulatory scope to include LDPs.”

Perhaps this is why the FDA has yet to implement regulations for LDTs. The controversy continues.

Whether Health Canada will accept the advice of the IHPME scientists and take steps to regulate laboratory-developed tests in Canada remains to be seen. As more LDTs are created and manufactured, however, it is probable that governments will continue to evaluate the administration and oversight of laboratory-developed tests.

In both Canada and the United States, pathologists, clinical laboratory managers, and executives at in vitro diagnostic manufacturers can expect an ongoing tug-of-war between government regulators and the lab industry over the most appropriate ways to regulate LDTs.

—JP Schlingman

Related Information:

Health Canada Needs to Act on Laboratory-developed Diagnostics

Laboratory Developed Tests

The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies

Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)

FDA Discussion Paper on Laboratory Developed Tests

FDA Announces Intention to Regulate LDTs as Devices

FDA Official Makes Case in Favor of LDT Guidance

Regulation of Laboratory Developed Tests by FDA: Time for the Agency to Cease and Desist Until Congress Enacts Legislation

Johns Hopkins University Study Finds Laboratory-Developed Liquid Biopsy Tests Can Give Different Results; Call for ‘Improved Certification’ of Medical Laboratories That Develop These LDTs

FDA Looks to Clamp Down on Laboratory-Developed Tests and Put an End to ‘Wild West of Medicine’: Might CLIA Problems at Theranos Support FDA’s Position?

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