Novamed unveils ‘home heart-attack test kit’

Start-up hopes for sales in US and Europe.

Novamed heart attack test 311 (photo credit: Courtesy)
Novamed heart attack test 311
(photo credit: Courtesy)
Dr. Emil Katz, founder and CEO of Israeli start-up Novamed, says everyone should have a heart attack test at home, to be on the safe side. “When you do the test, it says, ‘Rush to hospital,’ or ‘Carry on as usual.’ I don’t understand why the market hasn’t demanded this up to now.”
The answer is clear: Many people would gladly keep such a test at home, but it doesn’t exist yet. So Katz plans to launch one in a few months time, via pharmacies in Israel.
If that declaration had come from any other entrepreneur, it might have sounded too ambitious. But Katz has a history of developing diagnostic products that are rapidly adopted for clinical use. Novamed has developed many of the most popular diagnostic tests sold in Israel.
It has annual sales of $10 million, half of which derives from Israel, and it is profitable. The company employs 60 people.
Katz started developing is products 20 years ago, for Israel’s then undeveloped diagnostics market. Among other things, he developed the urine test cup with built-in test tube used by the General Health Fund for all its tests.
Novamed sells about 100 diagnostic products, most of them raw materials for generic molecular tests or tests that are easy to develop, but some of them are patent protected.
The company specializes in developing quick tests that give results within hours, compared with a day to two days for competing products.
Canadian fund Riverside bought Novamed for $10 million in 2007.
“Since then we have only grown,” Katz told Globes. I even slightly regret that I sold, but some of the partners wanted liquidity.
Katz was first interviewed by Globes in early 2010, when he told how Riverside had given him a blank check to buy Israeli diagnostics companies.
Despite that, no companies have been acquired. Katz says that no technology was found that suited the fund’s product pipeline.
The heart attack test is Novamed’s most exciting product. Today, patients suspected of being in the throes of a heart attack undergo a test in hospital to detect an enzyme called Troponin T. Its presence indicates that a heart attack has taken place.
“The Troponin test is a Roche patent,” says Dr. Igal Ruvinsky, Novamed's head of R&D. “However, a few companies have discovered Troponin I, which is no less effective for detecting heart attacks. There is no patent on its use, and various companies produce it in various ways.”
Novamed has also developed a test based on Troponin I, and on another material found to be effective in diagnosing heart attacks in recent years.
The two tests combined make it possible to detect more than 90% of patients with the disease, and, according to the company, they do so several hours earlier. “Heart attacks are perceived as something that happens in an instant, but in fact they develop over a period of days,” Katz says.
Just one drop In the past few years, self-diagnosis heart attack tests have been launched in China and in some European countries, but, according to Katz and Ruvinsky, they don’t offer a real solution to the problem.
What is unique about Novamed’s test is that it can be carried out on just a single drop of blood. This is what makes possible the transition from a test that only a qualified hospital nurse can carry out, to a blood test that anyone can do at home by pricking a finger.
“When a person suspects that they are having a heart attack, and they are in pain, perspiring, and trembling, it’s impossible to extract four drops of blood from their finger,” says Katz. “A test using one drop is the only possibility for launching a home test, or even a fast test for a hospital that does not require taking blood from a vein.”
How have you managed to base the test on just one drop of blood? Ruvinsky: “This is thanks to the filters in our test kit. They leave the blood cells behind, and only allow the blood fluid to flow into the test window. In the other tests, the red blood cells are torn and pour their contents into the test window, which makes it impossible to detect low levels of the enzyme. These tests are accurate only when the person is already at the height of the attack.”
Within 15 minutes at most, two lines appear in the test window, as in a pregnancy test: a control line and a test line indicating the presence of the enzyme. But even if the test is negative, it’s not possible to relax. “If the patient still feels unwell, he or she should still go to hospital. Alternatively, the test can be repeated after a while.”
In a trial carried out at Wolfson Hospital on 75 participants who came to the Accident and Emergency Department with heart attack symptoms, the company’s Troponin test identified 83% of the patients, the FABP test identified 89%, and combined, the tests identified 94% of patients in the early stages of the disease.
If the test does not rule out a heart attack, hospitals will still be flooded with hypochondriacs, so what have you achieved? Katz: “Anyone who is really having a heart attack and tests positive will not be complacent and will go to hospital immediately. That is much more important than weeding out the hypochondriacs.”
In the initial stage, planned to start in another few months, the product will be sold in Israeli pharmacies, and marketing activity will begin in Europe, but it is still a long way from approval by the US Food and Drug Administration. “For that, we will need to team up with a big company.”
Apart from this, Novamed is now setting up a company that it will partly own, in Russia, to produce and sell its products there. “In most western countries, there are already factories producing test like ours. In Russia, like in Israel 20 years ago, they are still concocted in the hospitals in an inefficient and not very professional way.”
In the US and Europe, Novamed is not setting up factories. In those places, it will only sell its patent-protected products. “The current focus is on Russia and the US. At this stage, that’s enough for me. Combined, these two markets have 500 million people. I manage to live well here, with a market of eight million.”