A close-up of the corona virus that causes Severe Acute Respiratory Syndrome. BioShaf’s early stage diagnosis kit was 97.6% effective in locating the virus.An Israeli company is close to completing the first kit that can diagnose SARS at an early stage. This breakthrough will help medical workers and officials control the spread of the highly contagious disease: the earlier that SARS cases are detected, the faster sufferers can be quarantined and their environs protected.

BioShaf, a biological startup near Haifa, has completed Phase I trials of the kit, which is designed to detect early-stage infection by the corona virus that causes Severe Acute Respiratory Syndrome. The trials encompassed blood samples from hundreds of patients, and rated the kits as being 97.6% effective.

The trials took place at the Control Disease Center in Beijing, which works with the World Health Organization’s Collaborating Center for Virus Reference and Research.

According to BioShaf founder and president, Dr. Shafrira Shai, the company hopes to start marketing the kit in China and southeast Asia with months.

“We began work on the SARS kit at the end of May, and we just completed the clinical trials,” Shai told ISRAEL21c. “Now we’re waiting for approval from the Chinese equivalent of the FDA. We’ve already started negotiations with a big company in China to produce the kits, and we expect them to be on the market there within two months. Then we’ll apply for FDA approval and look to the American market, and worldwide distribution,” Shai said.

The uniqueness of BioShaf’s kit, according to Shai, is its use of ELISA technology – standing for “enzyme-linked immunosorbent assay.” Since its discovery in 1960, ELISA technology has been utilized in an increasing number of biological and biochemical investigations and is proven to be one of the most powerful diagnosis tools available. ELISA technology is also commonly used to diagnose HIV, the virus responsible for AIDS.

The technology is based on the principle of an antibody-antigen reaction. If the SARS virus is present, the patient’s body develops antibodies, which can be detected using the antigen – synthetic segments of proteins deriving from the virus itself.

Shai says that the test takes only an hour and can also indicate how advanced the disease has become.

“The ELISA technology is a very popular method – every hospital knows how to use it,” she says.

BioShaf has spent some $2 million on developing the kit according to the financial daily The Marker. BioShaf is also working on establishing a joint venture to develop an immunization against SARS. It envisions an investment of $20 million to $30 million, to come from Chinese technology and biotechnology companies.

SARS first grabbed the world’s attention in February 2003, when the pneumonia-like disease attacked Guangdong, China. The Chinese government says 305 people contracted it from November 2002. From there the virus spread to Hong Kong, then to Vietnam and Canada. On March 12, the WHO issued a global alert. By April, the Vancouver Michael Smith Genome Sciences Center had sequenced the virus’s genome. Scientists have speculated that the virus may return this winter

Shai founded BioShaf in 1998 in order to develops and market an innovative medical diagnostics system for testing body fluids and cells, utilzing an advanced commercial laboratory instrument – the flowcytometer. The Flowcytometer, previously employed only in research and development facilities due to a very high price, became recently commercially available in its compact and inexpensive version

BioShaf offers the market a full line of kits, diagnosing the male and female simultaneously, allowing for a complete fertility analysis. BioShaf’s first product line is a complete and automated one-step infertility diagnostics system for both male and female. In less than two hours, the system identifies causes for infertility accurately and decisively. The system predicts success for fertilization treatments, identifies causes of early abortions, and provides the physician with a clear and detailed printout of the test results.

“During my PHD studies, I was involved in the fertility field, and met many couple with unexplained infertility problems. They were spending 10, 15 years going from one physician to another. I thought that it would be beneficial to create a diagnostics kits that could help them,” says Shai.

The BioShaf system saves patients time, money and anguish. It is the only diagnostic system that performs all the necessary tests (total of 25 parameters) for both male and female in a single phase. The system provides quick and subjective results that are extremely accurate and reliable. Some of the tests could replace the inaccurate, labor intensive and subjective light microscope methods. The new system allows for directing the couple to the most suitable treatment right away, therefore increasing the success rate of Assisted Reproductive Technology (ART).

Bioshaf’s second product line is designed to detect tumor markers, allowing early and accurate diagnosis of various kinds of cancer in organs such as the prostate, breast, liver, women reproductive system and others.

“The fertility kit has undergone studies at five clinical centers in the U.S. including the Mayo Clinic, and is waiting for FDA approval. Another kit based on semen analysis has been approved by the FDA ,” Shai says.

BioShaf was originally established under the umbrella of the Naiot Technology Incubator in Nazareth Illit, and obtained initial funding from both the Ofer Group and the Israeli Office of the Chief Scientist. In August 2000, the company moved out of the Incubator to its current premises in Haifa and completed a first round investment of $1.65 million from the NOGA Technology Investment Fund.

Shai holds a B.Sc. degree in Biological Sciences and a M.Sc. and Doctoral degree in Medical Sciences from the Faculty of Medicine at the Technion. Her research and publications have focused on cancer drug resistance, cancer immunotherapy, and immunoinfertility with extensive expertise in medical diagnosis and the treatment of infertility.