Diagnostics & Imaging Week Contributing Writer

Israel has an abundance of life science companies, many of which had their start in incubators, drawing upon technologies from the research programs of local universities, research institutes and hospitals. The Israeli government funds many early-stage companies through the Office of the Chief Scientist in the Ministry of Industry.

Special attention has been given to biotechnology, a rapidly growing area of research in Israel, fostered by the spirit of entrepreneurship and bolstered by interdisciplinary capabilities in computer systems, microelectronics and electro-optics.

The country’s life science industry encompasses a diverse range of diagnostic and imaging companies, a number of which are profiled in this two-part series that begins today and concludes in next week’s Diagnostics & Imaging Week.

Test kits, assays and genetic tests

Analyte Works (Nesher) is developing a platform for rapid test kits for quantitative urine point-of-care applications. It consists of a proprietary immunoassay technique in a dry cartridge, enabling a multi-step ELISA to be performed in a single step. Used along with an electro-optical reader, it affords a low-cost lab quality system.

The electronic measurement is normalized to the water content of urine. The company claims that there is no other simple platform for general-purpose immunoassay point-of-care applications that matches the dynamic range and sensitivity in a 15-minute test.

The product is aimed at the theranostics (monitoring drug dosage) and diagnostics markets.

Diagnostic Technologies (Haifa) is developing diagnostic tests on pregnant women’s blood for the early detection of high-risk pregnancies based on genomics and proteomics.

The company uses newly identified placental genes and proteins to detect abnormal pregnancy development related to pre-eclampsia, pre-term delivery and intrauterine growth restriction.

Its marker for pregnancy complications is placental protein 13 (PP-13), which is incorporated into an enzyme immunoassay kit that detects abnormal first and second trimester PP-13 levels. It is used to predict risk before complications develop in pregnancy.

It has been shown that by using placental explants it is possible to assess the effectiveness of putative drugs for pre-eclampsia. Thus, the risk of developing pre-eclampsia can now be followed on a continuing basis, allowing the tailoring of drug therapy.

NovaMed Diagnostics (Jerusalem) offers a diverse line of more than 100 products in the fields of clinical microbiology, immunodiagnostic kits and tools for cell biology research.

These include urine culture devices, a newly patented urine collection cup, one-step assays for rapid detection of viral and bacterial antigens, a latex agglutination test for viral gastroenteritis, separation tubes and columns for lymphocyte separation, and extracellular matrix coated plastic ware for growth of adherence-dependent cell lines.

The company is expanding its R&D of diagnostic products in the areas of cardiovascular diseases, hereditary diseases and cancer treatment.

InCure (Jerusalem) is developing an immunological kit for detection of solid carcinoma invasion and metastasis in blood samples. The company’s initial focus is on developing disease-driven gene-based diagnostic tests for breast and colon cancer.

These tests identify the PAR1 (proteolytically activated receptor-1) ligand that is over-expressed in highly metas-tatic biopsy specimens and has been found to play a central role in the malignant and physiological invasion processes in several cancers.

Healthcare Technologies (Ashdod) is a publicly traded firm that incubates medical diagnostic companies that are formed to develop and commercialize breakthroughs from Israel’s universities. Its affiliated companies specialize in the development, manufacture and marketing of clinical diagnostic test kits.

It has launched Savyon Diagnostics (Ashdod), Gamidor Diagnostics (Rehovot) and Danyel Biotech (Rehovot).

Savyon Diagnostics is a supplier of diagnostic kits for detection of infectious diseases that are based on immunological techniques (ELISA, MIF, IPA and rapid single tests) and are sold by 80 distributors worldwide. It also is an OEM manufacturer of diagnostic products.

Gamidor Diagnostics markets custom research kits and reagents used in molecular genetic analysis.

Danyel Biotech distributes a wide variety of products, including research reagents and instrumentation for genomic and proteomic applications, molecular biology research, cell culturing and magnetic-based separation of cells and cellular compartments.

Common Sense (Caesarea) develops home-use diagnostic products for women’s health. Its VI-Sense kit is used to classify common abnormal vaginal discharges and its AL-Sense kit detects leakage of amniotic fluid. These panty liner-based tests employ a polymer that undergoes a change in color in the presence of amniotic fluid (AL-Sense) or elevated pH levels/lowered buffer capacity (VI-Sense) that indicate a bacterial or parasitic vaginal infection.

Fluids with low ionic buffer capacity change the color of the polymer when pH levels are as low as 4.3, thereby indicating infectious situations that cannot be detected by intrusive devices available on the market.

Common Sense also has developed a point-of-care version of VI-Sense that will enable physicians to rule in or rule out bacterial or parasitic infections. VS-Sense is a swab test that offers the physician positive/negative results in a few seconds.

MND (Mobile Post Hefer) is developing diagnostic test kits for detecting a wide range of viruses including SARS-CoV, HRV coronavirus, rotavirus, meningitis, hepatitis C and HIV.

An advantage claimed for this test kit is that it can be rapidly adapted to other disease outbreaks more quickly than other detection systems. A proof-of-concept has been completed for MND’s technolog and initial clinical trials are expected to begin soon.

Pronto Diagnostics (Rehovot) is a provider of molecular diagnostics products. The company specializes in carrier screening, prenatal testing, disease predisposition and differential diagnosis. Its Pronto test kits provide rapid and accurate assays for detecting single nucleotide polymorphisms (SNPs) in DNA sequences. They are suited for both small- and large-scale clinical genetic analysis and have received CE-mark certification.

The Pronto technology uses a single nucleotide primer extension ELISA assay. It benefits from the high specificity with which DNA polymerase incorporates nucleotides into the elongating strand. Results are determined visually as well as analyzed by a standard ELISA reader.

Reagents, other tools

Biological Industries (Kibbutz Beit Haemek) manufactures reagents and kits that are sold to the life sciences R&D market for use in animal cell culture and for molecular biology. Its line of tissue culture products includes proprietary media products that are used in cytogenetics laboratories for amniocentesis and leukemia testing. These products have a large market share in European and Asian countries and are sold directly to end-users in the U.S. Current R&D efforts are directed at developing novel products for use with stem cells and for in vitro fertilization.

Molecular Cytomics (Ramat Gan) has developed the Optical LiveCell Array, a high-content analysis (HCA) and high-content screening (HCS) tool that enables both the study of individual living, adhering cells as well as individual, non-adhering cells such as blood or bone marrow, within a population.

Its disposable format can be used with any standard upright or inverted microscope and does not require a major capital investment in mainframe equipment. Current cytometry methods do not offer long-term sequential measurements on the same individual cells or group of cells. n

(Next week: Blood glucose monitors, diagnostic equipment and devices, imaging and computerized programs.)