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Breakthrough diagnostic kits for viral pandemics developed by Israeli scientist

Posted By Nicky Blackburn On November 11, 2007 @ 11:01 pm In | No Comments

Biotech expert Prof. Max Herzberg: I am confident that once MND makes it to the market with its innovative product, the diagnosis of medical conditions will undergo radical transformation.When the SARS (Severe acute respiratory syndrome) epidemic broke out in 2002, Israeli scientist Dorit Arad was alarmed. She was living in the US at the time, and had to fly frequently for her work, exposing herself to risk. During the outbreak, which lasted from November 2002 to July 2003, 774 people died of the highly contagious respiratory disease – a mortality rate of 9.6 percent.

“I was panicked,” admits Arad. “I even started wearing a mask.”

It gave her an idea, however. One of the problems with this pneumonia-like disease, was diagnosis, which was expensive, slow, and had a high rate of false positive results. At certain points during the outbreak, anyone in a risky area with a fever was hastily shut into quarantine, sometimes for as long as two months.

“It was effective because it stamped out the disease, but it was crazy,” says Arad.

What was needed, she realized, was a new diagnostic tool that could let doctors diagnose potential pandemic illnesses – such as SARS or influenza – on site, in minutes.

Being a leading scientist in the development of anti-viral drugs for US company, eXegenics, Arad turned her substantial knowledge to the task. Four years on, Arad’s new breakthrough diagnostic tests for viral pandemics, and a range of other illnesses such as Cytomegalovirus (CMV), meningitis, influenza, and even the common cold, are now going through proof of concept, and could be out on the market in as little as 18 months.

The diagnostic kit, which is being developed by Arad’s company, Modules for Novel Diagnostics (MND), is quick and simple to use. Saliva, blood, or even CF fluid is added to the test tube kit, and if a virus is present, the fluid within the test tube becomes fluorescent or changes color within two to 10 minutes.

The test can be carried out at any public location, and is designed for massive use at airports, government agencies, healthcare organizations, hospitals and clinics. There is no need for laboratory intervention or expensive equipment, and the test has a low false positive rate. The test can also be used to detect multiple viruses at one time.

“The test is very sensitive and is completely new. Unlike existing diagnostic tests, it does not try to detect antibodies, but actually focuses on detecting a live virus as it is the process of reproducing,” Arad, MND’s CTO explains to ISRAEL21c. “This is extremely innovative. In the last 20-30 years nothing has really changed in the field of diagnostics. There have been modifications and improvements to existing methods, but this is the first time something really new has emerged.”

Prof. Max Herzberg, a leading figure in the global biotech industry, one of the founding fathers of the Israeli biotech industry, and a member of MND’s board of directors, agrees. “As someone who has been involved in this area for three decades without witnessing any dramatic development, I believe the detection kit is a significant breakthrough. I am confident that once MND makes it to the market with its innovative product, the diagnosis of medical conditions will undergo radical transformation,” he says.

One of the first applications that MND is developing for the new kit is the detection of pandemic viruses. “The technology is very general so it can apply to every new virus that emerges. We divide viruses into families, and if an old virus mutates, or a new virus emerges we know which family it belongs to and can quickly find the system to produce a detection product for it,” says Arad.

“The general view today is that the next great pandemic will stem from avian flu, but tomorrow a new virus can emerge and we don’t know what it will be. With our knowledge we can still create a diagnostic kit,” she adds.

The company is also preparing a diagnostic kit for CMV, a herpes virus that can be extremely harmful to a baby in the womb. In the US, about 1-4% of pregnant women are infected with CMV for the first time during their pregnancy, and about one third of these pass the virus on to their unborn babies. While the virus often has little impact on the woman, it can have a major impact on the baby causing severe disabilities such as hearing and vision loss, mental disability, lung, liver, spleen and growth problems either at birth or later in life. Ever year in the US, about one in 750 children are born with, or develop, disabilities as a result of CMV infection.

Prenatal testing for this virus is mandatory in many countries, but the results are sent to a laboratory and take time. A woman tested at three months will only know for sure if she has the virus at five months. Many doctors recommend abortion, but at this stage it is a complicated and traumatic procedure. MND’s test will give immediate results, reducing the tense waiting time to just a few minutes, and enabling doctors to take action at a much earlier stage of the pregnancy.

The third kit being developed by MND is for bacterial meningitis, an inflammation of the linings that surround and protect the brain. About one million people suffer from meningitis every year in the US. There are two main types of meningitis, viral and bacterial – the first is a fairly mild disease, the second is deadly, unless treated promptly. The problem is that the symptoms are very similar, and today’s diagnostic tests, a lumbar puncture and CSF analysis, take one or two days to produce results. Doctors cannot take the risk of waiting this period to see which type of meningitis their patient has. Instead, they have to treat them immediately with strong antibiotics.

This means that most patients are being the given the wrong treatment, but it is also causing a crisis in antibiotic use. Today many bacteria have become resistant to drugs, because of over prescription of antibiotics.

“This is a very serious problem,” says Arad. “We are at a critical stage. Antibiotics were once the hope of the century, but they are now becoming ineffective and many diseases that were once treatable using these drugs, are now resistant, leaving us searching for new drugs.”

MND’s diagnosis takes just three minutes, enabling doctors to make the right treatment decisions on the spot. At present, the company uses CSF analysis, but Arad believes that in the near future the company will develop a kit to test for meningitis using blood.

The company has already developed proof of concept prototypes for these kits, and plans clinical trials over the next two years. “We should be on the market in one, to one and a half years with the meningitis diagnosis, and two years with the CMV and pandemic virus kits,” says Arad.

Following on the heels of these, Arad plans diagnostic kits for a whole range of other illnesses including AIDS, malaria, hepatitis, mumps, tuberculosis, foot and mouth disease (in animals), polio, and other worldwide epidemics.

MND’s technology is the culmination of Arad’s lifetime of research. She first began studying the field in post doctorate work in San Francisco in 1987, and has been working in the area since then. Some years ago, she took her research to the US company, eXegenics, where she worked as executive VP for five years, modeling drug design and creating new anti-viral drugs.

In 2004, Arad left eXegenics, buying back her research from the company. Initially she planned to set up MND in the US and had already spoken to local VC companies, but a problem with a stolen passport meant her visa to the US could not be renewed for six months. So Arad decided to change course and approached Israel’s Yozmot Granot Initiative Center. In May that year, MND was founded.

MND left the incubator in 2006 and for the next year, Arad continued to fund the company with her own money. The company also began paid collaborative work with a French company, BMD. Together the two companies combined their technologies creating a diagnosis kit that can detect a range of respiratory diseases like bronchitis, pneumonia, sinusitis and ear infections at one go.

In July this year, the company raised $4.7 million in their first financing round from a group of private investors from Switzerland, headed by the Dreyfus and Merilous families. The investors have announced that the plan to invest more in the company, which is moving to the Weizmann Science Park in Rehovot, at a later stage.

Aside from MND, Arad has also founded another company, NLC Pharma, in the US. This company, set up in 2004, is exploring the other side of Arad’s work – treatment. “Using the same research from MND we are developing anti-viral drugs,” says Arad. “We already have lead components that are very effective for SARS, the common cold, and foot and mouth disease.”

The company is now at the pre-clinical stage, but Arad says she expects to be able to reach the market with treatments fairly quickly using FDA shortcuts once clinical trials are underway. “There is nothing like this on the market,” she explains. “Our aim is to have ready bullets of treatments for all pandemic families of diseases.”

In fact, Arad admits, her original goal was to develop anti-viral treatments only, but along the way she discovered that viral diagnosis was a lucrative and important field in its own right. Globally, the diagnostic market is estimated at $40 billion annually. “In fact, MND was a byproduct of my real research, but diagnosis has turned out to be much bigger than I thought it would be at the start. There is a real gap in the market,” Arad says.

Her long-term goal is to be able to do it all – to prevent, diagnose, and treat infectious diseases. “Our mission is to be ready for any new viral epidemic,” she says. “The damage caused by the fear of SARS was 10 times greater than the economic damage caused by the tsunami in 2004. We are fighting against fear. We fear things we cannot see and cannot protect ourselves from. We are targeting that fear, making the unknown, known.”

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