Until about six months ago, as we waited in line to do Covid-19 PCR tests, then waited for days for results, we wondered whether this process would ever be replaced with a home test. Now, we perform the same test ourselves and get results within 15 minutes, without leaving the house. (Even though, at the end of the process, we can't really be sure if we don't have Covid - but why bother with petty details).
Antigen testing is the harbinger of things to come, indicating the way that lab testing - or rather, non-lab testing - can go. But antigen tests also demonstrate the challenges of this market, and how much more progress it must make to be of value.
Israeli company Novamed, which has been developing and marketing laboratory test components for almost 30 years, has in recent years developed several pioneering products for at-home testing. The company's founder, Emil Katz, sold control (70%) to Simplivia Healthcare for some NIS 24 million about a year ago. Simplivia, which is controlled by private equity firm FIMI Opportunity Funds and operates out of Teva's former Tevadaptor Kiryat Shmona plant, is readying for an IPO.
As part of the changeover, Katz stepped down as CEO, and will fill roles in invention and development. Ellit Mann-Bitton, a former senior executive at Teva, was appointed in his place. Today she leads the company together with chairman Ori Yehudai, the former CEO of Frutarom.
Simplivia now wants to take advantage of the leap forward in the home diagnostics market that happened during the Covid-19 period, to launch Novamed out of Israel and deliver its innovations to the whole world.
"Diagnostics have had a huge upgrade over the past two years and become one of the most interesting fields in the global health sector," says Mann-Bitton. "The antigen test created an amazing change. It empowered the consumer. Now, everyone knows how to do home tests. Covid brought tests out of hiding in the lab and put them not just front and center, but into all of our hands.
"Home testing relates very much to the order of the day: preventive medicine, remote medicine, consumers' control over their health, and not just in infectious diseases. It's one of the important elements in the health sector's transformation."
Detecting a heart attack at home
The flagship product that launched Novamed on its journey was a sample collection cup which, we can safely say, took over Israel's urine testing market. The cup has two chambers that allow both a general urine test and a urine culture test to be performed simultaneously without having to open the lid to perform the culture.
Novamed also provides a kit that enables culture to start growth while the sample is still at the nurse's station, thus shortening the time needed to grow a quantity of bacteria sufficient for testing. In addition, the company sells many other lab test products.
As for at-home tests, Israelis may have already encountered Novamed's streptococcus test, which has been marketed in Israel for several years. The company also sells pregnancy tests and flu tests, as well as another new product that was announced a decade ago but only recently hit the market: a home-use test for early diagnosis of acute myocardial infarction (AMI). The test detects the presence of troponin, a protein that indicates damage to the heart caused by an attack. "And Emil (Katz) did that back when at-home diagnostics was just an afterthought," Mann-Bitton says admiringly.
This test has been approved for use in Israel. It is not yet available for home use, but is being used in the field, for example by ambulance personnel, and is undergoing approval processes in other countries. "The test was developed before Covid, but when lockdowns came into effect, the need increased significantly. The tests met a market need and that had an impact. But that's just the beginning, just an example of what can be done," says Mann-Bitton.
Aiming for 97% accuracy
During the Covid period, Novamed produced PCR sampling kits. These days, it is working on developing coronavirus testing kits that are saliva-based, as opposed to invasive nasal swabs. "This modification has already happened in other places," says Mann-Bitton, "and we're working on it with the regulator in an accelerated process. I hope we'll see it on the market when the next wave comes."
According to Mann-Bitton, future home-use tests will make it possible to take an oral cavity sample, stick it in a plastic container, press a button, and that will be all. No need to mess about with mixing or droplets. "We're currently using this technology with Streptococcus testing but it may be relevant for a range of other products."
"In the not-too-distant future," Mann-Bitton says, "everyone will always keep a set of tests at home. Just like we have a thermometer or blood pressure monitor, we'll have strep, coronavirus, flu, and heart attack tests, along with others. Diagnosis today represents only 2% of the drug sector, but it brings huge benefits, and home tests save money because they reduce the need for professional sampling and lab technicians."
This vision is truly wonderful. We all seem to be waiting for it. But in the end, antigen tests have proved a disappointment. Not everyone is able to sample well, results leave lots of room for doubt, and we usually do additional tests to confirm results, so there is also no cost savings to the system.
"There's no doubt that everything we've said will only happen if we have kits with high levels of accuracy that anyone can operate. That's why we, too, are increasing R&D investments greatly, and connecting with partners for whom quality and accuracy are the most important thing. The goal is at least 97% accuracy for every test. "
Even before home kits, there's an intermediate market that can be penetrated: neighborhood testing facilities with a professional technician, which can also provide rapid results. This was Theranos's vision.
"Definitely. It's very important to obtain reliable, immediate information when visiting a clinic. It will save on the need to make another appointment before results are received."
Targeting developing countries
Yehudai previously estimated that, excluding revenues on coronavirus tests, in recent years Novamed recorded revenue of about NIS 30 million a year, at high profitability. The company currently employs about 100 people. Most of its activity is in Israel, with a little activity in Eastern Europe and the US. Breaking into additional markets, Yehudai estimated, could lead to doubling or tripling sales.
In the past, Novamed was sold at prices similar to its current value; it appears to be maintaining stability in terms of its activity. Katz sold the company to US private equity fund The Riverside Company in 2007 for $10 million, and bought it back for $12-13 million in 2013.
"Our goal is to reach the developing world, but also the developed world," says Mann-Bitton. "There will be places where our urine culture products will be too advanced for the testing facility. At other places, existing products have already been integrated with local automation systems and integration is therefore more difficult. In bacteriology, there is an advantage to local production because shelf life is short. We're currently examining the different markets, in urine testing, virology and rapid testing. Simplivia provides strong support to Novamed, from synergies with the production system, through financing, to the entire marketing outlook."
Being part of Simplivia, and in this way also part of FIMI, allows Novamed to consider significant collaborations with - and perhaps also of acquisitions of - synergistic companies abroad.
A vibrant but challenging market
More than 10 million people have already spat into a 23andMe test tube to get their genetic data analyzed. If a complex thing like genetic decoding can be done at home, surely the home testing market is close to a breakthrough, isn't it? Well, not yet.
The need for a certain amount of material (blood, urine, saliva or phlegm) needed for accurate processing, combined with the ability to "read" results, limits today's home market to "wet" tests. Take Theranos for example. All it needed to fulfill its vision of offering close-to-home testing was the ability to extract information from a very small amount of blood. That's exactly what it failed to do.
But the vision was correct. Now, more than ever, technological changes are enabling information to be extracted from smaller and smaller amounts of body fluids. These changes are taking place in a scientific field called microfluidics, meaning the control of very small amounts of fluid. The global pandemic gave this market a boost, and significant progress is expected in the coming years.
Advances in body fluid analysis
There are markets that have already undergone this revolution. For example, home pregnancy tests, which were once very complicated, are now fairly simple and accurate, and there are blood sugar tests that can be performed not only with a finger prick, but by using a continuous measuring device. Things are far simpler when substances do not need to be extracted from the body - from the temperature and blood pressure monitors we all know, to at-home sleep monitoring (like Itamar Medical's), and even heart rate monitors that can diagnose cardiac arrhythmia. Pulsenmore even offers home ultrasound tests for fetal monitoring, as well as ovarian follicle tests for fertilization planning - replacing many hours of clinical testing.
In recent years, more products have been introduced to the market that allow diagnosis at home using body fluids, such as kidney function tests, the antigen tests we have come to know, drug tests, and even rapid AIDS tests that provide results within 20 minutes - though then the question arises of what sort of support or information someone can get if they receive a positive result, alone looking at the dreaded stripe.
The Israeli players
Several Israeli players operate in the home "lab" testing market. For example, Healthy.io, a company for self-testing the urine albumin to creatinine ratio; OutSense, which is developing a test for screening fecal occult blood; Sight Diagnostics, a company that has developed a high-performance complete blood count (CBC) analyzer that provides accurate results in minutes (though not for home use), and previously developed a rapid malaria test; and MeMed, which has developed a test that differentiates between bacterial and viral infection, and hopes to adapt it for home use in the future. In the US, Visby Medical, founded by the Israeli Adam de la Zerda, has developed rapid PCR tests, currently for STDs and coronaviruses, and hopefully, later on, for any disease that can be diagnosed by PCR.
This market is bustling and vibrant with an annual turnover of between $10 billion and $20 billion, depending on how you slice it. However, the number of tests accurate enough to save on a visit to a professional lab is still low. For example, rapid AIDS tests are less sensitive than their lab counterparts, which can lead to fatal consequences. A variety of tests are sold around the world, but their benefit to a complete diagnosis is not entirely clear, and there are concerns that subjects will misunderstand the results of a test or their significance.
Covid-19 moved this field forward, both because it accelerated new technological developments and because it raised awareness of the possibility of at-home testing. We've gotten used to having everything delivered to the home at the push of a button. Therefore, the home testing market is also expected to grow, and hopefully it will also provide better answers in the years to come.
- Activity: Development and marketing of components for laboratory tests.
- History: Founded in 1995 by Emil Katz. A year ago, he sold control to Simplivia Healthcare for NIS 24 million.
- Vital Statistics: Employs about 100 employees. Annual revenue is estimated at NIS 30 million a year, excluding Covid-19 revenue.
- One more thing: The company's Chairman is Ori Yehudai, former CEO of Frutarom.
Published by Globes, Israel business news - en.globes.co.il - on February 28, 2022.
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