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Disgraced Theranos Founder Elizabeth Holmes to Serve 11 Years, Three Months in Prison, Ending the Latest Chapter in the Story of the Failed Clinical Laboratory Company

Judge will decide the restitution Holmes must pay to defrauded Theranos investors at future court date; Ex-COO Ramesh “Sunny” Balwani to be sentenced next month

Clinical laboratory leaders and anatomic pathologists who closely followed the fraud trial of Elizabeth Holmes may have wondered how the Theranos founder and ex-CEO would be punished for her crimes. Now we know.

On Friday, a federal court judge sentenced Holmes to 135 months—11.25 years—in prison in the culmination of her conviction on three felony counts of wire fraud and one count of conspiracy, according to NBC Bay Area News.

Late into the four-hour sentencing hearing, Holmes tearfully spoke, according to a twitter post by NBC reporter Scott Budman, who was in the courtroom. “I am devastated by my failings,” Holmes said. “I have felt deep pain for what people went through because I have failed them … To investors, patients, I am sorry.”

Davila ordered Holmes to surrender to authorities on April 27 to begin her time behind bars. She is free until that time. Her upcoming prison term caps off one of the biggest downfalls ever of an American entrepreneur.

[We first published this article in our Dark Daily E-Briefings newsletter. Sign up for free here to stay informed on the lab industry’s most important news and events.]

Elizabeth Holmes

Elizabeth Holmes (above), founder and former CEO of Theranos, the now defunct clinical laboratory company, as she enters the federal courthouse in San Jose, Calif., prior to her sentencing on Friday. In January, Holmes was convicted on three counts of wire fraud and one count of conspiracy. Last summer, Theranos’ former CLIA laboratory director, pathologist Adam Rosendorff, MD, expressed remorse over his testimony which led to Holmes’ defense team requesting a new trial. The judge denied that request and allowed the sentencing of Holmes to proceed as scheduled. (Photo copyright: Jim Wilson/The New York Times.)

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Defense Lawyers Plan to Appeal

Dean Johnson, JD, a California criminal defense lawyer, told NBC Bay Area News during live coverage of the hearing on Friday that Holmes’ defense team will appeal her conviction.

“I have no doubt there will be an appeal in this case,” Johnson said.

Judge Edward Davila, who oversaw Holmes’ trial and sentencing hearing in US District Court in San Jose, Calif., estimated that the total loss for Theranos investors was $121 million. Investors had committed funds to support the company’s flawed Edison blood testing technology. A separate restitution hearing for Holmes will be scheduled for a later date.

Beyond the sentencing, Holmes, 38, will be saddled by infamy for the rest of her life, with her past reputation as a charismatic innovator ruined.

In “Theranos Ex-CEO Elizabeth Holmes Convicted on Three Counts of Wire Fraud and One Count of Conspiracy to Commit Fraud after Seven Days of Jury Deliberations,” we covered how a jury convicted Holmes in January on four charges of investor and wire fraud after a four-month trial. She faced up to 20 years in prison on each of those counts.

Another Theranos executive, former Chief Operating Officer and President Ramesh “Sunny” Balwani, faces sentencing on Dec. 7. A jury found Balwani guilty of two counts of conspiracy and 10 counts of wire fraud in July.

“The judge [said] evidence shows Elizabeth Holmes was leader of the company, but not necessarily the leader of the criminal acts,” Budman tweeted. Those words clearly pointed to Balwani, who Holmes’ defense team had painted as exerting control over her and the company.

Prosecutors Sought a Stiffer Sentence for Holmes

Prosecutors had asked Davila to sentence Holmes to 15 years in prison, arguing that her conviction represented “one of the most substantial white collar offenses Silicon Valley or any other district has seen,” according to NBC Bay Area News, which cited court documents. The government also wanted her to pay $803 million in restitution.

Holmes’ defense team, however, wished for no prison time at all, instead asking that Holmes serve time under house arrest. “If a period of confinement is necessary, the defense suggests that a term of 18 months or less, with a subsequent supervised release period that requires community service, will amply meet that charge,” her lawyers wrote in a court filing.

Prior to the sentencing, Davila received 130 letters supporting Holmes and asking for leniency, NPR reported. Among them was a note from William “Billy” Evans, Holmes’ partner.

“If you are to know Liz, it is to know that she is honest, humble, selfless, and kind beyond what most people have ever experienced,” Evans wrote, NPR reported. “Please let her be free.”

Holmes and Evans have a 16-month-old son together, and she is pregnant with the couple’s second child. Her first pregnancy caused her trial to be rescheduled. Prior to last week’s sentencing, some reporters covering the trial speculated that because Holmes was the mother of an infant—and now pregnant again—the judge might be more lenient in sentencing. The 11-year, four-month sentence indicates that the judge was not much influenced by that factor.

Last Minute Pitch for New Trial Failed

Holmes’ legal wranglings continued until the very end.

On Nov. 7, Davila denied her motion for a new trial. Holmes’ lawyers had argued that key prosecution witness Adam Rosendorff, MD—a pathologist who was former laboratory director at the company—expressed remorse about his own 2021 testimony during an attempt to visit Holmes’ residence on August 2022. Dark Daily covered this event in “Clinical Pathologist Once Again at the Center of a National News Story as Theranos Founder Elizabeth Holmes Seeks New Trial.”

However, Rosendorff later told the court that he stood by his testimony about problems with Theranos’ blood testing technology.

In denying the request for a new trial, Davila wrote, “The court finds Dr. Rosendorff’s statements under oath to be credible,” according to The Washington Post.

From Teen Founder to Disgraced Entrepreneur

Holmes founded Theranos in 2003 at age 19 while she was attending Stanford University as a chemical engineering major. She dropped out of Stanford as a sophomore to focus on her new company.

Theranos claimed its technology—known as Edison—could perform diagnostics tests using a finger prick and a micro-specimen vial instead of a needle and several Vacutainers of blood. The company said it could return results to patients and clinicians in four hours for about half of the cost of typical lab test fees.

However, the promise of this technology began to unravel in 2015 following an investigative article by The Wall Street Journal that revealed the company ran only a handful of tests using its technology, instead relying on traditional testing for most of its specimen work.

Following The Journal’s exposé, the Centers for Medicare and Medicaid Services (CMS) sanctioned Theranos and Holmes in 2016. Meanwhile, the US Securities and Exchange Commission (SEC) investigated Holmes for raising hundreds of millions from investors by exaggerating or making false statements about the company’s technology and financial performance.

In 2018, the US Department of Justice (DOJ) indicted Holmes and Balwani, and Theranos closed shortly after.

Convictions Validated Pathologists’, Hospital Lab Leaders’ Concerns

Fortunately, the Theranos saga has not stunted investment in healthcare technology startups. Spending was in the tens of billions in 2021, although that number has dropped this year as the COVID-19 pandemic has waned, according to TechCrunch. Nevertheless, it is safe to assume that healthcare tech investors are scrutinizing scientific data from startups more thoroughly because of the Theranos fraud case.

Meanwhile, the saga of Theranos continues to leave a bad taste in the mouths of many clinical laboratory managers and pathologists. That’s because, during the peak period of adulation and spectacular news coverage about Elizabeth Holmes and her plans to totally disrupt the clinical laboratory industry, hospital and health system CEOs believed that they would be able to downsize their in-house medical laboratories and obtain lab tests from Theranos at savings of 50% or more. Consequently, during the years 2013 through the end of 2015, some hospital lab leaders saw requests for capital investment in their labs denied or delayed.

One example of how hospital CEOs embraced news of Theranos’ blood testing technology took place at the Cleveland Clinic. Elizabeth Holmes did such a good job selling the benefits of the Edison technology, then-CEO, Toby Cosgrove, MD, placed Theranos at number three on its list of top ten medical innovations for 2015.

In later years, Cosgrove admitted that no one at Cleveland Clinic or its pathologists were allowed to examine the analyzers and evaluate the technology.

It was for these reasons that the demise of Theranos was welcomed by many hospital lab administrators and pathologists. The fact that two of Theranos’ senior executives have been convicted of fraud validates many of the serious concerns that medical laboratory professionals had at that time, but which most major news reporters and media ignored and failed to report to the public.

Scott Wallask

Related Information:

Theranos Founder Elizabeth Holmes Sentenced to More than 11 Years in Prison

Elizabeth Holmes Is Sentenced to More than 11 Years for Fraud

Theranos Ex-CEO Elizabeth Holmes Convicted on Three Counts of Wire Fraud and One Count of Conspiracy to Commit Fraud after Seven Days of Jury Deliberations

Prosecutors Push 15-year Sentence for Theranos’ CEO Holmes

Elizabeth Holmes Sentenced to 11 Years in Prison for Theranos Fraud

Clinical Pathologist Once Again at the Center of a National News Story as Theranos Founder Elizabeth Holmes Seeks New Trial

Bid for New Trial Fails, Elizabeth Holmes Awaits Sentencing

Ramesh “Sunny” Balwani Convicted by a Jury on 12 Counts of Fraud in Theranos Trial

Hot Startup Theranos Has Struggled with Its Blood-Test Technology

California-Based Genomics Startup Secures $600 Million in Funding to Deliver $100 Whole Human Genome with Its New High-Throughput, Low-Cost Sequencing Platform

Ultima Genomics says it is emerging from “stealth mode” with millions in fresh capital and technology capable of sequencing whole human genomes for a fraction of the cost

Investors seem to be optimistic that an emerging genetics company has the proprietary solution to sequence a whole human genome for just $100. If true, this is a development that would be of interest to clinical laboratory managers and pathologists.

The company, Ultima Genomics of Newark, Calif., recently announced that it had raised $600 million from the investment community. In a press release last month, the company announced it has “emerged from stealth mode with a new high-throughput, low-cost sequencing platform that delivers the $100 genome.”

The press release goes on to state that Ultima will unleash a new era in genomics-driven discoveries by developing a “fundamentally new sequencing architecture designed to scale beyond conventional approaches, including completely different approaches to flow cell engineering, sequencing chemistry, and machine learning.”

Are we at the cusp of a revolution in genomics? Ultima Genomics’ founder and CEO, Gilad Almogy, PhD, believes so.

“Our architecture is intended for radical scaling, and the $100 genome is merely the first example of what it can deliver,” he said in the press release. “We are committed to continuously drive down the cost of genomic information until it is routinely used in every part of the healthcare system.”

From an Estimated Cost of $3 Billion to $450 in Just 30 Years!

Whole genome sequencing (WGS) has decreased dramatically in cost since research into the technology required got started in the early 1990s with the publicly-funded Human Genome Project. At that time, the cost to sequence the entire human genome was estimated at around $3 billion. Then, in 1998, John Craig Venter created Celera Genomics (now a subsidiary of Quest Diagnostics) and was the first to sequence the whole human genome (his own) and at a significantly lower cost of around $300 million.

The cost continued to drop as technology improved. In 2001, the cost to sequence the whole human genome hovered around $100 million. Twenty years later that cost had dropped to about $450/sequence, according to data compiled by the National Human Genome Research Institute (NHGRI), a division of the National Institutes of Health (NIH).

When DNA sequencer Illumina announced in 2014 the arrival of the $1,000 genome, the news was expected to put whole genome sequencing on the road to becoming routine, Forbes reported. But that prediction didn’t pan out.

Ultima Genomics’ $100 price point, however, could be game changing. It would make the cost of decoding a human genome affordable for nearly everyone and accelerate the growth of personalized medicine in clinical laboratory diagnostics.

Applied Physics versus Biological Sciences

According to GEN, Almogy brings a tech background to Ultima—his PhD is in applied physics, not the biological sciences. He founded Ultima in 2016 after serving as founder, president, and CEO at Fulfil Solutions, a manufacturer of custom automation robotics systems. At Ultima, his goal is to “unleash the same relentless scaling in sequencing” that was used to drive down the cost of computing power and transform modern life.

“Ultima is the real deal, with good technology,” Raymond McCauley, cofounder and Chief Architect at BioCurious, and Chair of Digital Biology at Singularity Group, told Singularity Hub. “They’ve been working on an Illumina killer for years.”

Gilad Almogy, PhD
 “We designed our new sequencing architecture to scale beyond conventional technologies, and are excited to soon make the UG 100, our first instrument using this architecture, commercially available to more customers,” said Gilad Almogy, PhD (above), Ultima Genomics’ founder and CEO, in a press release. “In the future, we aim to continuously improve our technology, further drive down costs, and increase the scale of genomic information to improve patient outcomes.” At $100/sequence, whole genome sequencing may well become commonly available to improve precision medicine diagnostics and clinical laboratory testing. (Photo copyright: Ultima Genomics.)

In late May, Ultima released “Cost-efficient Whole Genome-Sequencing Using Novel Mostly Natural Sequencing-by-Synthesis Chemistry and Open Fluidics Platform,” a preprint that details the technology underlying Ultima’s UG100 platform. That news was followed by presentations of early scientific results by research institutes currently using Ultima’s technology during the Advances in Genome Biology and Technology 2022 annual meeting.

TechCrunch reported that Ultima’s UG100 sequencing machine and software platform can perform a complete sequencing of a human genome in about 20 hours, with precision comparable to existing options, but does so at a far lower cost per gigabase (Gb), equal to one billion base pairs.

According to the Ultima Genomics website, its breakthroughs include:

  • An open substrate that creates a massive, low-cost reaction surface that delivers many billions of reads while avoiding costly flow cells and complicated fluidics.
  • Novel scalable chemistry that combines the speed, efficiency, and read lengths of natural nucleotides with the accuracy and scalability of endpoint detection.
  • A revolutionary sequencing hardware that uses spinning circular wafers that enable efficient reagent use, zero crosstalk, and ultra-high-speed scanning of large surfaces.

“We may be on the brink of the next revolution in sequencing,” Beth Shapiro, DPhil, an evolutionary molecular biologist at the University of California, Santa Cruz (UCSC), told Science. Shapiro is a professor of ecology and evolutionary biology and an HHMI Investigator at UCSC and Director of Evolutionary Genomics at the UCSC Genomics Institute.

Ultima Genomics maintained a low profile since its founding six years ago. But that changed in May when it announced it had raised $600 million from multiple investors, including:

Affordable Genomics Will Lead to ‘Millions of Tests per Year’

Exact Sciences’ Chairman and CEO Kevin Conroy—whose Wisconsin-based molecular diagnostics company recently entered into a long-term supply agreement for Ultima Genomic’s NGS technologies—believes low-cost genomic sequencing will improve cancer screening and disease monitoring.

“Exact Sciences believes access to differentiated and affordable genomics technologies is critical to providing patients better information before diagnosis and across all stages of cancer treatment,” Conroy said in a press release. “Ultima’s mission to drive down the cost of sequencing and increase the use of genomic information supports our goal to provide accurate and affordable testing options across the cancer continuum. This is particularly important for applications like cancer screening, minimal residual disease, and recurrence monitoring, which could lead to millions of tests per year.”

GEN pointed out that Ultima’s 20-hour turnaround time is fast and its quality on par with its competitors, but that it is Ultima’s $1/Gb price (noted in the preprint) that will set it apart. That cost would be a fraction of Illumina’s NextSeq ($20/Gb) and Element Biosciences’ AVITI ($5/Gb).

Almogy told TechCrunch that Ultima is working with early access partners to publish more proof-of-concept studies showing the capabilities of the sequencing technique, with broader commercial deployment of the technology in 2023. Final pricing is yet to be determined, he said.

If the $100 genome accelerates the pace of medical discoveries and personalized medicine, clinical laboratory scientists and pathologists will be in ideal positions to capitalize on what the executives and investors at Ultima Genomics hope may become a revolution in whole human genome sequencing and genomics. 

—Andrea Downing Peck

Related Information:

Ultima Genomics Delivers the $100 Genome

Ultima Genomics Claims $100 Full Genome Sequencing after Stealth $600M Raise

A $100 Genome? New DNA Sequencers Could Be a ‘Game Changer’ for Biology, Medicine

Ultima Genomics and Exact Sciences Enter Long-Term Supply Agreement Aimed at Improving Patient Access to Genomic Testing by Driving Down Sequencing Costs

Cost-Efficient Whole Genome-Sequencing Using Novel Mostly Natural Sequencing-by-Synthesis Chemistry and Open Fluidics Platform

Ultima Genomics Bursts onto the Scene Targeting the “$100 Genome”

MGI Announces Commercial Availability of DNBSEQ Sequencers in the United States

The $1,000 Genome Arrives–for Real, This Time

Ultima Genomics Claims the $100 Genome and Raises $600M to Go Even Lower

‘Femtech’ Diagnostic Start-up Firms Want to Provide Women with At-Home Tests for Health Conditions That Currently Require Tests Done by Clinical Laboratories

Several young companies hope to expand the direct-to-consumer test market by introducing new diagnostic tests to serve the women’s health market

Providing women with at-home lab test kits is the goal of a growing class of start-up companies that are bringing to market consumer test kits for a range of health conditions common to women. These companies believe they can shift a substantial volume of such testing away from the nation’s medical laboratories.

Moreover, diagnostic startups that develop at-home direct-to-consumer (DTC) clinical laboratory genetic tests have been hot commodities among venture capitalists and other healthcare investors willing to put tens of millions of dollars into these new firms. The New York Times observed that, until recently, women’s healthcare needs have rarely been the focus of new diagnostic testing companies, but that the situation may be changing.

Femtech” (short for female technology) products and services that address the health and wellness needs of women is the new buzz word in healthcare. It describes female-focused diagnostic startups aiming at vaginal health and other medical issues that go beyond reproductive health concerns.

This, however, is a dual-edged sword for clinical laboratory leaders. Growth in this segment could lead to new diagnostics tests that boost a medical lab’s bottom line or, conversely, it could reduce revenue as patients self-diagnose urinary tract infections (UTIs), yeast infections, and other conditions through at-home DTC testing.

Michelle Tempest, MD

“The market potential is huge,” Michelle Tempest, MD (above), a partner at the London-based healthcare consulting firm Candesic, told The New York Times. “There’s definitely an increasing appetite for anything in the world which is technology and a realization that female consumer power has arrived—and that it’s arrived in healthcare.” Tempest maintains the women’s health marketplace is ripe for growth, which could mean a boon for clinical laboratory testing and diagnostics designed specifically for women. (Photo copyright: Candesic.)

Vaginal Microbiome At-home Clinical Laboratory Tests in High Demand

One area in particular drawing the attention of several female-led startups is vaginal health. According to an article in Vogue, test developers Juno Bio and Evvy are leading the way with at-home vaginal microbiome tests that let users “know what’s up down there.”

New York City-based Evvy ($129 for a single test or $99 each for four tests per year) uses metagenomic sequencing to identify the bacteria and fungi present in the vaginal microbiome. This information helps customers to understand their levels of protective and disruptive bacteria, which can be associated with everything from reoccurring infections and transmission of sexually transmitted diseases to infertility.

London-based Juno Bio ($149 per test) does not disclose its testing method. It does, however, provide users with a “full vaginal microbiome profile.” The profile is accessed online within a “few days” of returning the vaginal swab sample to the company’s clinical laboratory.

Both companies note that their tests are intended to be used for wellness purposes and are not meant to diagnose or treat disease or substitute for a physician’s consultation.

Gynecologist Oluwatosin Goje, MD, MSCR, FACOG, a reproductive infectious disease specialist at Cleveland Clinic, believes the availability of at-home vaginal microbiome testing will provide valuable information to both women and their doctors.

“It’s a powerful tool because it enables us to look at the entire microbial community through metagenomics and decipher how the overall composition might be affecting symptoms and infections, as well as determine the best treatment pathway,” Goje, an Evvy Medical Advisor, told Vogue. “Understanding the complete vaginal microbiome allows us to be good antibiotic stewards and only administer antibiotics when needed. Patients can also retest remotely to understand how antibiotics and other treatments impacted their vaginal microbiome.”

Evvy, an at-home vaginal microbiome test

Evvy, which offers women an at-home vaginal microbiome test (above) that can provide insights into chronic vaginal infections and proclivity to contract sexually transmitted diseases and other women’s health issues, is one of several women-led diagnostic start-ups focused on women’s health. (Photo copyright: Evvy.)

Removing the Discomfort of Shopping for Women’s Health Products

Jamie Norwood and Cynthia Plotch, co-founders of Stix, a supplier of women’s health products and education, launched their company with a product line of at-home pregnancy and ovulation tests. They have since expanded their offerings to include urinary tract infection (UTI) and yeast infection testing and treatments.

“You can test, relieve, treat, and help prevent future infections—all from the comfort of your own home,” Norwood, told Vogue. She emphasized that this is the kind of experience healthcare consumers are demanding in today’s ever-growing direct-to-consumer clinical laboratory testing landscape. “Agonizing over confusing over-the-counter products in the drugstore aisles, or bending over backwards to pick up a prescription at the pharmacy, just isn’t cutting it for Millennial and Gen Z consumers.”

According to WebMD, yeast infections are a chronic problem for many women. While 75% of women will get at least one yeast infection in their lifetime, up to 8% get more than four a year. In addition, the federal Centers for Disease Control and Prevention (CDC) points out that bacterial vaginosis is the most common vaginal condition in females ages 15-44.

Lola Priego, is CEO and founder of blood test company Base, which sells at-home saliva and finger-prick blood tests to monitor hormone levels, vitamin levels, neurotransmitters, and blood cell markers to improve everything from sleep and diet to sex drive. She predicts direct-to-consumer testing will become as common as fitness watches.

“Eventually, at-home lab testing will be another readily-used tool, similar to your health-tracking wearables, that helps us optimize for a well-rounded healthy lifestyle in a more individualized way,” Priego told Vogue.

Femtech a ‘Significantly Underdeveloped’ Market

In its latest Analyst Note, financial data firm PitchBook maintained that the market for female health products is poised for growth. TechCrunch, which reviewed PitchBook’s analysis of female-focused health products, reported that Femtech remains a “significantly underdeveloped” slice of health-tech spending.

While women spend an estimated $500 billion annually on medical expenses, only 4% of research and development money is targeted at women’s health, PitchBook noted. In its analysis, Pitchbook predicted the global market for female-focused health products will reach $3 billion by the end of 2030. By comparison, that segment of the healthcare market totaled $820.6 million last year.

“While we still view Femtech as a niche industry, we believe secular drivers could help propel new growth opportunities in the space,” PitchBook analysts wrote. “These include the increasing representation of women in the venture-backed technology community, rising awareness and acceptance of women’s health issues, and the growing prevalence of infectious diseases among women in some countries in Africa and Asia.

“Furthermore, while the majority of Femtech products have traditionally focused on reproductive health, we believe new approaches to women’s health research will help open the door to new products and services,” they noted.

Clinical laboratory leaders will be wise to carefully watch the growth of at-home DTC tests and products targeted at female healthcare consumers since fewer trips to physicians’ offices may mean fewer test orders for local labs.

At the same time, the opportunity exists for innovative pathologists and lab managers to develop digital services that allow consumers who are self-testing to store their home-test results in the lab’s app. They can then receive relevant insights from clinical pathologists to help them fully understand the implications of the test results.

—Andrea Downing Peck

Related Information:

Vaginal Health Is Finally at the Forefront: These Are the Startups Destigmatizing UTIs and Yeast Infections

Is ‘Femtech’ the Next Big Thing in Healthcare?

Backed by $5M Led by General Catalyst, Evvy Launches a Vaginal Microbiome Test to Support Women’s Health Research

Stanford Graduates Develop At-Home Vaginal Microbiome Test for Women with Reoccurring Infections and Even Infertility

Femtech VC Space Poised for Growth

Femtech Poised for Growth Beyond Fertility

Pitchbook Analyst Note: Femtech Expected to Break New Grounds

How Three Startups Are Furthering At-Home Healthcare

Bloodless Malaria Test Could Signal Major Breakthrough for Early Detection of Diseases Using Light Instead of Traditional Clinical Laboratory Tests

This low-cost, reusable noninvasive light test could serve as a prototype for detecting other biomarkers and diseases in rural and outlying medical laboratories

A 24-year-old Ugandan computer scientist whose own malaria was missed by traditional clinical laboratory blood tests has developed a device that detects signs of the disease using a beam of light directed onto a patient’s finger. The light highlights and detects changes in the color, shape, and concentration of red bloods cells affected by disease.

Brian Gitta, CEO and co-founder of computer software company thinkIT Limited, became the youngest winner of the UK’s Royal Academy of Engineering Africa Prize for Engineering Innovation. His eHealth solution is called Matibabu, which means “treatment” in Swahili.

Gitta and his team are developing a low-cost, reusable device that clips onto a patient’s finger and provides malaria test results within 60 seconds through a mobile phone app, UPI.com reported. The latest Matibabu prototype uses a ‘hybrid of magnetic-optic technology and electro-impedance technology’ to detect the disease,” according to a blog post on the thinkIT website.

“Our next step is to determine the validity and reliability of the Matibabu device compared with the gold standard microscopy and RDT by conducting field tests with malaria patients in selected health facilities in order to obtain information that will be used to improve the device, and eventually roll it out to the market,” the blog post states.

The Matibabu malaria detection device (above) uses the principles of light scattering and magnetism to detect changes to red blood cells that signal disease. The low-cost, reusable device from thinkIT Limited has advanced through several prototypes and now has an estimated 80% accuracy rate. (Photo copyright: Makerere University College of Engineering, Design, Art and Technology.)

TechCrunch reported that the current generation of Matibabu is about 80% accurate, with the expectation that further development will increase the device’s accuracy to 90-95%.

While this new diagnostic technology needs further development and clinical studies, it could potentially be used for other biomarkers and diseases besides malaria. However, according to the Centers for Disease Control and Prevention (CDC), rapid diagnostic tests (RDTs) like this are not yet widely used, so speed-of-diagnosis also is an issue.

Nevertheless, if successful, such a non-invasive test for malaria would be a major breakthrough since, today, the mosquito-borne disease must be confirmed by medical laboratory blood tests using either microscopic diagnosis or antigen detection, which are costly and time consuming.

“It’s a perfect example of how engineering can unlock development—in this case by improving healthcare,” Rebecca Enonchong, Africa Prize judge, noted in a Royal Academy of Engineering statement. “Matibabu is simply a gamechanger.”

Africa Prize judge Rebecca Enonchong (left) presents Ugandan Brian Gitta (right) of Matibabu with the Africa Prize winner’s medal. (Photo/caption copyright: Royal Academy of Engineering.)

Shafik Sekitto, Matibabu Vice President of Business Development, told BBC World News that Gitta’s own battle with malaria was prolonged because the first three blood tests failed to diagnose his disease. “[Gitta] brought up the idea: ‘Why can’t we find a new way of using the skills we have in computer science—of diagnosing a disease without having to prick somebody?’” Sekitto explained.

Malaria Threatens Half the World’s Population

The World Health Organization (WHO) estimates that nearly half the world’s population is at risk of malaria. According to WHO estimates, in 2015 there were 429,000 deaths worldwide from malaria, with 90% of cases and 92% of deaths in sub-Saharan Africa.

The Africa Prize, which includes a $33,400 (124-million Uganda shillings) award, is Africa’s biggest prize dedicated to engineering innovation. Its sponsors aim to encourage engineers from sub-Saharan Africa “to apply their skills to develop scalable solutions to local challenges.” In addition to funding, award recipients also receive business training, mentoring, and access to the Royal Academy of Engineering’s network of high profile and experienced engineers and experts, and their networks.

Gitta expects the award of the Africa Prize will help thinkIT Limited better navigate the difficult process of gaining worldwide regulatory approval for a new diagnostic device.

“It’s such a big achievement for us, because it means that we can better manage production in order to scale clinical trials and prove ourselves to regulators,” he predicted in the Royal Academy of Engineering statement. “The recognition will help us open up partnership opportunities—which is what we need most at the moment.”

Many pathologists and clinical laboratory managers are watching the efforts of various companies to develop medical laboratory tests that can be performed with a device that is coupled to a smartphone and can be performed as a point-of-care test. A substantial proportion of these research efforts are targeting the needs for accurate diagnostic testing in developing countries. That’s because of the need for cheap, fast, and accurate assays that can be performed in the rural areas of these nations.

—Andrea Downing Peck

Related Information:

Ugandan Inventor Wins Africa Prize for Bloodless Malaria Test

Ugandan Innovation Wins the Africa Prize for Engineering Innovation

Ugandan Wins Africa Prize for Bloodless Malaria Test

Matibabu Uses Light to Diagnose Malaria

Matibabu Wins the Africa Prize for Engineering Innovation

 

 

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