Short Story Contest Winner: "The Gerry Program"
A father and son gaze at the ducks in a lake.
It's an odd sensation knowing you're going to die, but it was a feeling Gerry Ferguson had become relatively acquainted with over the past two years. What most perplexed the terminally ill, he observed, was not the concept of death so much as the continuation of all other life.
Gerry's secret project had been in the works for two years now, ever since they found the growth.
Who will mourn me when I'm gone? What trait or idiosyncrasy will people most recall? Will I still be talked of, 100 years from now?
But Gerry didn't worry about these questions. He was comfortable that his legacy would live on, in one form or another. From his cozy flat in the west end of Glasgow, Gerry had managed to put his affairs in order and still find time for small joys.
Feeding the geese in summer at the park just down from his house, reading classics from the teeming bookcase in the living room, talking with his son Michael on Skype. It was Michael who had first suggested reading some of the new works of non-fiction that now littered the large oak desk in Gerry's study.
He was just finishing 'The Master Algorithm' when his shabby grandfather clock chimed six o'clock. Time to call Michael. Crammed into his tiny study, Gerry pulled his computer's webcam close and waved at Michael's smiling face.
"Hi Dad! How're you today?"
"I'm alright, son. How're things in sunny Australia?"
"Hot as always. How's things in Scotland?"
"I'd 'ave more chance gettin' a tan from this computer screen than I do goin' out there."
Michael chuckled. He's got that hearty Ferguson laugh, Gerry thought.
"How's the project coming along?" Michael asked. "Am I going to see it one of these days?"
"Of course," grinned Gerry, "I designed it for you."
Gerry's secret project had been in the works for two years now, ever since they found the growth. He had decided it was better not to tell Michael. He would only worry.
The two men chatted for hours. They discussed Michael's love life (or lack thereof), memories of days walking in the park, and their shared passion, the unending woes of Rangers Football Club. It wasn't until Michael said his goodbyes that Gerry noticed he'd been sitting in the dark for the best part of three hours, his mesh curtains casting a dim orange glow across the room from the street light outside. Time to get back to work.
*
Every night, Gerry sat at his computer, crawling forums, nourishing his project, feeding his knowledge and debating with other programmers. Even at age 82, Gerry knew more than most about algorithms. Never wanting to feel old, and with all the kids so adept at this digital stuff, Gerry figured he should give the Internet a try too. Besides, it kept his brain active and restored some of the sociability he'd lost in the previous decades as old friends passed away and the physical scope of his world contracted.
This night, like every night, Gerry worked away into the wee hours. His back would ache come morning, but this was the only time he truly felt alive these days. From his snug red brick home in Scotland, Gerry could share thoughts and information with strangers from all over the world. It truly was a miracle of modern science!
*
The next day, Gerry woke to the warm amber sun seeping in between a crack in the curtains. Like every morning, his thoughts took a little time to come into focus. Instinctively his hand went to the other side of the bed. Nobody there. Of course; she was gone. Rita, the sweetest woman he'd ever known. Four years this spring, God rest her soul.
Puttering around the cramped kitchen, Gerry heard a knock at the door. Who could that be? He could see two women standing in the hallway, their bodies contorted in the fisheye glass of the peephole. One looked familiar, but Gerry couldn't be sure. He fiddled with the locks and pulled the door open.
"Hi Gerry. How are you today?"
"Fine, thanks," he muttered, still searching his mind for where he'd seen her face before.
Noting the confusion in his eyes, the woman proffered a hand. "Alice, Alice Corgan. I pop round every now and again to check on you."
It clicked. "Ah aye! Come in, come in. Lemme get ya a cuppa." Gerry turned and shuffled into the flat.
As Gerry set about his tiny kitchen, Alice called from the living room, "This is Mandy. She's a care worker too. She's going to pay you occasional visits if that's alright with you."
Gerry poked his head around the doorway. "I'll always welcome a beautiful young lady in ma home. Though, I've tae warn you I'm a married man, so no funny business." He winked and ducked back into the kitchen.
Alice turned to Mandy with a grin. "He's a good man, our Gerry. You'll get along just fine." She lowered her voice. "As I said, with the Alzheimer's, he has to be reminded to take his medication, but he's still mostly self-sufficient. We installed a medi-bot to remind him every day and dispense the pills. If he doesn't respond, we'll get a message to send someone over."
Mandy nodded and scribbled notes in a pad.
"When I'm gone, Michael will have somethin' to remember me by."
"Also, and this is something we've been working on for a few months now, Gerry is convinced he has something…" her voice trailed off. "He thinks he has cancer. Now, while the Alzheimer's may affect his day-to-day life, it's not at a stage where he needs to be taken into care. The last time we went for a checkup, the doctor couldn't find any sign of cancer. I think it stems from--"
Gerry shouted from the other room: "Does the young lady take sugar?"
"No, I'm fine thanks," Mandy called back.
"Of course you don't," smiled Gerry. "Young lady like yersel' is sweet enough."
*
The following week, Mandy arrived early at Gerry's. He looked unsure at first, but he invited her in.
Sitting on the sofa nurturing a cup of tea, Alice tried to keep things light. "So what do you do in your spare time, Gerry?"
"I've got nothing but spare time these days, even if it's running a little low."
"Do you have any hobbies?"
"Yes actually." Gerry smiled. "I'm makin' a computer program."
Alice was taken aback. She knew very little about computers herself. "What's the program for?" she asked.
"Well, despite ma appearance, I'm no spring chicken. I know I don't have much time left. Ma son, he lives down in Australia now, he worked on a computer program that uses AI - that's artificial intelligence - to imitate a person."
Alice still looked confused, so Gerry pressed on.
"Well, I know I've not long left, so I've been usin' this open source code to make ma own for when I'm gone. I've already written all the code. Now I just have to add the things that make it seem like me. I can upload audio, text, even videos of masel'. That way, when I'm gone, Michael will have somethin' to remember me by."
Mandy sat there, stunned. She had no idea anybody could do this, much less an octogenarian from his small, ramshackle flat in Glasgow.
"That's amazing Gerry. I'd love to see the real thing when you're done."
"O' course. I mean, it'll take time. There's so much to add, but I'll be happy to give a demonstration."
Mandy sat there and cradled her mug. Imagine, she thought, being able to preserve yourself, or at least some basic caricature of yourself, forever.
*
As the weeks went on, Gerry slowly added new shades to his coded double. Mandy would leaf through the dusty photo albums on Gerry's bookcase, pointing to photos and asking for the story behind each one. Gerry couldn't always remember but, when he could, the accompanying stories were often hilarious, incredible, and usually a little of both. As he vividly recounted tales of bombing missions over Burma, trips to the beach with a young Michael and, in one particularly interesting story, giving the finger to Margaret Thatcher, Mandy would diligently record them through a Dictaphone to be uploaded to the program.
Gerry loved the company, particularly when he could regale the young woman with tales of his son Michael. One day, as they sat on the sofa flicking through a box of trinkets from his days as a travelling salesman, Mandy asked why he didn't have a smartphone.
He shrugged. "If I'm out 'n about then I want to see the world, not some 2D version of it. Besides, there's nothin' on there for me."
Alice explained that you could get Skype on a smartphone: "You'd be able to talk with Michael and feed the geese at the park at the same time," she offered.
Gerry seemed interested but didn't mention it again.
"Only thing I'm worried about with ma computer," he remarked, "is if there's another power cut and I can't call Michael. There's been a few this year from the snow 'n I hate not bein' able to reach him."
"Well, if you ever want to use the Skype app on my phone to call him you're welcome," said Mandy. "After all, you just need to add him to my contacts."
Gerry was flattered. "That's a relief, knowing I won't miss out on calling Michael if the computer goes bust."
*
Then, in early spring, just as the first green buds burst forth from the bare branches, Gerry asked Mandy to come by. "Bring that Alice girl if ya can - I know she's excited to see this too."
The next day, Mandy and Alice dutifully filed into the cramped study and sat down on rickety wooden chairs brought from the living room for this special occasion.
An image of Gerry, somewhat younger than the man himself, flashed up on the screen.
With a dramatic throat clearing, Gerry opened the program on his computer. An image of Gerry, somewhat younger than the man himself, flashed up on the screen.
The room was silent.
"Hiya Michael!" AI Gerry blurted. The real Gerry looked flustered and clicked around the screen. "I forgot to put the facial recognition on. Michael's just the go-to name when it doesn't recognize a face." His voice lilted with anxious excitement. "This is Alice," Gerry said proudly to the camera, pointing at Alice, "and this is Mandy."
AI Gerry didn't take his eyes from real Gerry, but grinned. "Hello, Alice. Hiya Mandy." The voice was definitely his, even if the flow of speech was slightly disjointed.
"Hi," Alice and Mandy stuttered.
Gerry beamed at both of them. His eyes flitted between the girls and the screen, perhaps nervous that his digital counterpart wasn't as polished as they'd been expecting.
"You can ask him almost anything. He's not as advanced as the ones they're making in the big studios, but I think Michael will like him."
Alice and Mandy gathered closer to the monitor. A mute Gerry grinned back from the screen. Sitting in his wooden chair, the real Gerry turned to his AI twin and began chattering away: "So, what do you think o' the place? Not bad eh?"
"Oh aye, like what you've done wi' it," said AI Gerry.
"Gerry," Alice cut in. "What did you say about Michael there?"
"Ah, I made this for him. After all, it's the kind o' thing his studio was doin'. I had to clear some space to upload it 'n show you guys, so I had to remove Skype for now, but Michael won't mind. Anyway, Mandy's gonna let me Skype him from her phone."
Mandy pulled her phone out and smiled. "Aye, he'll be able to chat with two Gerry's."
Alice grabbed Mandy by the arm: "What did you tell him?" she whispered, her eyes wide.
"I told him he can use my phone if he wants to Skype Michael. Is that okay?"
Alice turned to Gerry, who was chattering away with his computerized clone. "Gerry, we'll just be one second, I need to discuss something with Mandy."
"Righto," he nodded.
Outside the room, Alice paced up and down the narrow hallway.
Mandy could see how flustered she was. "What's wrong? Don't you like the chatbot? I think it's kinda c-"
"Michael's dead," Alice spluttered.
"What do you mean? He talks to him all the time."
Alice sighed. "He doesn't talk to Michael. See, a few years back, Michael found out he had cancer. He worked for this company that did AI chatbot stuff. When he knew he was dying he--" she groped in the air for the words-- "he built this chatbot thing for Gerry, some kind of super-advanced AI. Gerry had just been diagnosed with Alzheimer's and I guess Michael was worried Gerry would forget him. He designed the chatbot to say he was in Australia to explain why he couldn't visit."
"That's awful," Mandy granted, "but I don't get what the problem is. I mean, surely he can show the AI Michael his own chatbot?"
"No, because you can't get the AI Michael on Skype. Michael just designed the program to look like Skype."
"But then--" Mandy went silent.
"Michael uploaded the entire AI to Gerry's computer before his death. Gerry didn't delete Skype. He deleted the AI Michael."
"So… that's it? He-he's gone?" Mandy's voice cracked. "He can't just be gone, surely he can't?"
The women stood staring at each other. They looked to the door of the study. They could still hear Gerry, gabbing away with his cybercopy.
"I can't go back in there," muttered Mandy. Her voice wavered as she tried to stem the misery rising in her throat.
Alice shook her head and paced the floor. She stopped and stared at Mandy with grim resignation. "We don't have a choice."
When they returned, Gerry was still happily chatting away.
"Hiya girls. Ya wanna ask my handsome twin any other questions? If not, we could get Michael on the phone?"
Neither woman spoke. Gerry clapped his hands and turned gaily to the monitor again: "I cannae wait for ya t'meet him, Gerry. He's gonna be impressed wi' you."
Alice clasped her hands to her mouth. Tears welled in the women's eyes as they watched the old man converse with his digital copy. The heat of the room seemed to swell, becoming insufferable. Mandy couldn't take it anymore. She jumped up, bolted to the door and collapsed against a wall in the hallway. Alice perched on the edge of her seat in a dumb daze, praying for the floor to open and swallow the contents of the room whole.
Oblivious, Gerry and his echo babbled away, the blue glow of the screen illuminating his euphoric face. "Just wait until y'meet him Gerry, just wait."
Questions remain about new drug for hot flashes
In May, a new drug, Fezolinetant, was approved by the FDA to treat hot flashes associated with menopause.
Vascomotor symptoms (VMS) is the medical term for hot flashes associated with menopause. You are going to hear a lot more about it because a company has a new drug to sell. Here is what you need to know.
Menopause marks the end of a woman’s reproductive capacity. Normal hormonal production associated with that monthly cycle becomes erratic and finally ceases. For some women the transition can be relatively brief with only modest symptoms, while for others the body's “thermostat” in the brain is disrupted and they experience hot flashes and other symptoms that can disrupt daily activity. Lifestyle modification and drugs such as hormone therapy can provide some relief, but women at risk for cancer are advised not to use them and other women choose not to do so.
Fezolinetant, sold by Astellas Pharma Inc. under the product name Veozah™, was approved by the Food and Drug Administration (FDA) on May 12 to treat hot flashes associated with menopause. It is the first in a new class of drugs called neurokinin 3 receptor antagonists, which block specific neurons in the brain “thermostat” that trigger VMS. It does not appear to affect other symptoms of menopause. As with many drugs targeting a brain cell receptor, it must be taken continuously for a few days to build up a good therapeutic response, rather than working as a rescue product such as an asthma inhaler to immediately treat that condition.
Hot flashes vary greatly and naturally get better or resolve completely with time. That contributes to a placebo effect and makes it more difficult to judge the outcome of any intervention. Early this year, a meta analysis of 17 studies of drug trials for hot flashes found an unusually large placebo response in those types of studies; the placebo groups had an average of 5.44 fewer hot flashes and a 36 percent reduction in their severity.
In studies of fezolinetant, the drug recently approved by the FDA, the placebo benefit was strong and persistent. The drug group bested the placebo response to a statistically significant degree but, “If people have gone from 11 hot flashes a day to eight or seven in the placebo group and down to a couple fewer ones in the drug groups, how meaningful is that? Having six hot flashes a day is still pretty unpleasant,” says Diana Zuckerman, president of the National Center for Health Research (NCHR), a health oriented think tank.
“Is a reduction compared to placebo of 2-3 hot flashes per day, in a population of women experiencing 10-11 moderate to severe hot flashes daily, enough relief to be clinically meaningful?” Andrea LaCroix asked a commentary published in Nature Medicine. She is an epidemiologist at the University of California San Diego and a leader of the MsFlash network that has conducted a handful of NIH-funded studies on menopause.
Questions Remain
LaCroix and others have raised questions about how Astellas, the company that makes the new drug, handled missing data from patients who dropped out of the clinical trials. “The lack of detailed information about important parameters such as adherence and missing data raises concerns that the reported benefits of fezolinetant very likely overestimate those that will be observed in clinical practice," LaCroix wrote.
In response to this concern, Anna Criddle, director of global portfolio communications at Astellas, wrote in an email to Leaps.org: “…a full analysis of data, including adherence data and any impact of missing data, was submitted for assessment by [the FDA].”
The company ran the studies at more than 300 sites around the world. Curiously, none appear to have been at academic medical centers, which are known for higher quality research. Zuckerman says, "When somebody is paid to do a study, if they want to get paid to do another study by the same company, they will try to make sure that the results are the results that the company wants.”
Criddle said that Astellas picked the sites “that would allow us to reach a diverse population of women, including race and ethnicity.”
A trial of a lower dose of the drug was conducted in Asia. In March 2022, Astellas issued a press release saying it had failed to prove effectiveness. No further data has been released. Astellas still plans to submit the data, according to Criddle. Results from clinical trials funded by the U.S. goverment must be reported on clinicaltrials.gov within one year of the study's completion - a deadline that, in this case, has expired.
The measurement scale for hot flashes used in the studies, mild-moderate-severe, also came in for criticism. “It is really not good scale, there probably isn’t a broad enough range of things going on or descriptors,” says David Rind. He is chief medical officer of the Institute for Clinical and Economic Review (ICER), a nonprofit authority on new drugs. It conducted a thorough review and analysis of fezolinestant using then existing data gathered from conference abstracts, posters and presentations and included a public stakeholder meeting in December. A 252-page report was published in January, finding “considerable uncertainty about the comparative net health benefits of fezolinetant” versus hormone therapy.
Questions surrounding some of these issues might have been answered if the FDA had chosen to hold a public advisory committee meeting on fezolinetant, which it regularly does for first in class medicines. But the agency decided such a meeting was unnecessary.
Cost
There was little surprise when Astellas announced a list price for fezolinetant of $550 a month ($6000 annually) and a program of patient assistance to ease out of pocket expenses. The company had already incurred large expenses.
In 2017 Astellas purchased the company that originally developed fezolinetant for $534 million plus several hundred million in potential royalties. The drug company ran a "disease awareness” ad, Heat on the Street, hat aired during the Super Bowl in February, where 30 second ads cost about $7 million. Industry analysts have projected sales to be $1.9 billion by 2028.
ICER’s pre-approval evaluation said fezolinetant might "be considered cost-effective if priced around $2,000 annually. ... [It]will depend upon its price and whether it is considered an alternative to MHT [menopause hormone treatment] for all women or whether it will primarily be used by women who cannot or will not take MHT."
Criddle wrote that Astellas set the price based on the novelty of the science, the quality of evidence for the drug and its uniqueness compared to the rest of the market. She noted that an individual’s payment will depend on how much their insurance company decides to cover. “[W]e expect insurance coverage to increase over the course of the year and to achieve widespread coverage in the U.S. over time.”
Leaps.org wrote to and followed up with nine of the largest health insurers/providers asking basic questions about their coverage of fezolinetant. Only two responded. Jennifer Martin, the deputy chief consultant for pharmacy benefits management at the Department of Veterans Affairs, said the agency “covers all drugs from the date that they are launched.” Decisions on whether it will be included in the drug formulary and what if any copays might be required are under review.
“[Fezolinetant] will go through our standard P&T Committee [patient and treatment] review process in the next few months, including a review of available efficacy data, safety data, clinical practice guidelines, and comparison with other agents used for vasomotor symptoms of menopause," said Phil Blando, executive director of corporate communications for CVS Health.
Other insurers likely are going through a similar process to decide issues such as limiting coverage to women who are advised not to use hormones, how much copay will be required, and whether women will be required to first try other options or obtain approvals before getting a prescription.
Rind wants to see a few years of use before he prescribes fezolinetant broadly, and believes most doctors share his view. Nor will they be eager to fill out the additional paperwork required for women to participate in the Astellas patient assistance program, he added.
Safety
Astellas is marketing its drug by pointing out risks of hormone therapy, such as a recent paper in The BMJ, which noted that women who took hormones for even a short period of time had a 24 percent increased risk of dementia. While the percentage was scary, the combined number of women both on and off hormones who developed dementia was small. And it is unclear whether hormones are causing dementia or if more severe hot flashes are a marker for higher risk of developing dementia. This information is emerging only after 80 years of hundreds of millions of women using hormones.
In contrast, the label for fezolinetant prohibits “concomitant use with CYP1A2 inhibitors” and requires testing for liver and kidney function prior to initiating the drug and every three months thereafter. There is no human or animal data on use in a geriatric population, defined as 65 or older, a group that is likely to use the drug. Only a few thousand women have ever taken fezolinetant and most have used it for just a few months.
Options
A woman seeking relief from symptoms of menopause would like to see how fezolintant compares with other available treatment options. But Astellas did not conduct such a study and Andrea LaCroix says it is unlikely that anyone ever will.
ICER has come the closest, with a side-by-side analysis of evidence-based treatments and found that fezolinetant performed quite similarly and modestly as the others in providing relief from hot flashes. Some treatments also help with other symptoms of menopause, which fezolinetant does not.
There are many coping strategies that women can adopt to deal with hot flashes; one of the most common is dressing in layers (such as a sleeveless blouse with a sweater) that can be added or subtracted as conditions require. Avoiding caffeine, hot liquids, and spicy foods is another common strategy. “I stopped drinking hot caffeinated drinks…for several years, and you get out of the habit of drinking them,” says Zuckerman.
LaCroix curates those options at My Meno Plan, which includes a search function where you can enter your symptoms and identify which treatments might work best for you. It also links to published research papers. She says the goal is to empower women with information to make informed decisions about menopause.
A company in England has made a test that picks out the compounds from breath that reveal if people have liver disease.
Every year, around two million people worldwide die of liver disease. While some people inherit the disease, it’s most commonly caused by hepatitis, obesity and alcoholism. These underlying conditions kill liver cells, causing scar tissue to form until eventually the liver cannot function properly. Since 1979, deaths due to liver disease have increased by 400 percent.
The sooner the disease is detected, the more effective treatment can be. But once symptoms appear, the liver is already damaged. Around 50 percent of cases are diagnosed only after the disease has reached the final stages, when treatment is largely ineffective.
To address this problem, Owlstone Medical, a biotech company in England, has developed a breath test that can detect liver disease earlier than conventional approaches. Human breath contains volatile organic compounds (VOCs) that change in the first stages of liver disease. Owlstone’s breath test can reliably collect, store and detect VOCs, while picking out the specific compounds that reveal liver disease.
“There’s a need to screen more broadly for people with early-stage liver disease,” says Owlstone’s CEO Billy Boyle. “Equally important is having a test that's non-invasive, cost effective and can be deployed in a primary care setting.”
The standard tool for detection is a biopsy. It is invasive and expensive, making it impractical to use for people who aren't yet symptomatic. Meanwhile, blood tests are less invasive, but they can be inaccurate and can’t discriminate between different stages of the disease.
In the past, breath tests have not been widely used because of the difficulties of reliably collecting and storing breath. But Owlstone’s technology could help change that.
The team is testing patients in the early stages of advanced liver disease, or cirrhosis, to identify and detect these biomarkers. In an initial study, Owlstone’s breathalyzer was able to pick out patients who had early cirrhosis with 83 percent sensitivity.
Boyle’s work is personally motivated. His wife died of colorectal cancer after she was diagnosed with a progressed form of the disease. “That was a big impetus for me to see if this technology could work in early detection,” he says. “As a company, Owlstone is interested in early detection across a range of diseases because we think that's a way to save lives and a way to save costs.”
How it works
In the past, breath tests have not been widely used because of the difficulties of reliably collecting and storing breath. But Owlstone’s technology could help change that.
Study participants breathe into a mouthpiece attached to a breath sampler developed by Owlstone. It has cartridges are designed and optimized to collect gases. The sampler specifically targets VOCs, extracting them from atmospheric gases in breath, to ensure that even low levels of these compounds are captured.
The sampler can store compounds stably before they are assessed through a method called mass spectrometry, in which compounds are converted into charged atoms, before electromagnetic fields filter and identify even the tiniest amounts of charged atoms according to their weight and charge.
The top four compounds in our breath
In an initial study, Owlstone captured VOCs in breath to see which ones could help them tell the difference between people with and without liver disease. They tested the breath of 46 patients with liver disease - most of them in the earlier stages of cirrhosis - and 42 healthy people. Using this data, they were able to create a diagnostic model. Individually, compounds like 2-Pentanone and limonene performed well as markers for liver disease. Owlstone achieved even better performance by examining the levels of the top four compounds together, distinguishing between liver disease cases and controls with 95 percent accuracy.
“It was a good proof of principle since it looks like there are breath biomarkers that can discriminate between diseases,” Boyle says. “That was a bit of a stepping stone for us to say, taking those identified, let’s try and dose with specific concentrations of probes. It's part of building the evidence and steering the clinical trials to get to liver disease sensitivity.”
Sabine Szunerits, a professor of chemistry in Institute of Electronics at the University of Lille, sees the potential of Owlstone’s technology.
“Breath analysis is showing real promise as a clinical diagnostic tool,” says Szunerits, who has no ties with the company. “Owlstone Medical’s technology is extremely effective in collecting small volatile organic biomarkers in the breath. In combination with pattern recognition it can give an answer on liver disease severity. I see it as a very promising way to give patients novel chances to be cured.”
Improving the breath sampling process
Challenges remain. With more than one thousand VOCs found in the breath, it can be difficult to identify markers for liver disease that are consistent across many patients.
Julian Gardner is a professor of electrical engineering at Warwick University who researches electronic sensing devices. “Everyone’s breath has different levels of VOCs and different ones according to gender, diet, age etc,” Gardner says. “It is indeed very challenging to selectively detect the biomarkers in the breath for liver disease.”
So Owlstone is putting chemicals in the body that they know interact differently with patients with liver disease, and then using the breath sampler to measure these specific VOCs. The chemicals they administer are called Exogenous Volatile Organic Compound) probes, or EVOCs.
Most recently, they used limonene as an EVOC probe, testing 29 patients with early cirrhosis and 29 controls. They gave the limonene to subjects at specific doses to measure how its concentrations change in breath. The aim was to try and see what was happening in their livers.
“They are proposing to use drugs to enhance the signal as they are concerned about the sensitivity and selectivity of their method,” Gardner says. “The approach of EVOC probes is probably necessary as you can then eliminate the person-to-person variation that will be considerable in the soup of VOCs in our breath.”
Through these probes, Owlstone could identify patients with liver disease with 83 percent sensitivity. By targeting what they knew was a disease mechanism, they were able to amplify the signal. The company is starting a larger clinical trial, and the plan is to eventually use a panel of EVOC probes to make sure they can see diverging VOCs more clearly.
“I think the approach of using probes to amplify the VOC signal will ultimately increase the specificity of any VOC breath tests, and improve their practical usability,” says Roger Yazbek, who leads the South Australian Breath Analysis Research (SABAR) laboratory in Flinders University. “Whilst the findings are interesting, it still is only a small cohort of patients in one location.”
The future of breath diagnosis
Owlstone wants to partner with pharmaceutical companies looking to learn if their drugs have an effect on liver disease. They’ve also developed a microchip, a miniaturized version of mass spectrometry instruments, that can be used with the breathalyzer. It is less sensitive but will enable faster detection.
Boyle says the company's mission is for their tests to save 100,000 lives. "There are lots of risks and lots of challenges. I think there's an opportunity to really establish breath as a new diagnostic class.”