Diagnostics & Imaging Week Contributing Writer

SINGAPORE – The in vitro diagnostics market in Asia accounts for only about 12% of the global IVD market (see Table 1 below), but is attracting growing interest from suppliers based in the U.S. and Europe as well as Asian competitors because of the potential for explosive growth in the region.

Trends in the clinical diagnostics market in Asia were discussed at the inaugural Diagnostics Asia 2006 conference, organized by IBC Asia Pte Ltd. (Singapore) and held here last month.

Advanced technologies, such as those for performing molecular diagnostic testing, are becoming important factors in the market.

A large proportion of the diagnostics market in Asia is attributable to Japan, with other important country markets in China, India and Australia. Market growth, however, is strong, particularly in China and India, although competing against domestic suppliers in countries such as China can prove challenging for U.S. and European companies.

In particular, companies in China are beginning to incorporate advanced technologies into their products, and moving beyond simple generic test strip technologies.

As discussed by Lucy Lu, vice president, technology development for Roche Diagnostics (Indianapolis) at the conference, molecular diagnostics is the most rapidly growing segment of the diagnostics market, expanding at a 15% annual rate and reaching $1.8 billion worldwide in 2005.

As shown in Table 2 below, more than 85% of the market is attributable to sales of infectious disease testing products on a global basis, including instruments and reagents used for infectious disease diagnosis, blood screening tests,NULL, and products used for viral load testing and viral genotyping. The remainder of the market, totaling about $255 million in 2004, is attributable primarily to products used in cancer and genetic disease testing.

Molecular diagnostics has progressed from direct nucleic acid probe testing and a market size of less than $1 million in 1983, to a market of $65 million in 1993 consisting both of tests employing amplification methods such as polymerase chain reaction (PCR) and bDNA as well as direct testing, to the current market that includes products based on at least five amplification technologies, dominated by PCR, which accounts for half of the global market.

The recent expiration of key patents such as the patents covering PCR has opened the market to smaller suppliers who can sell PCR-based tests free of royalties. Suppliers such as Bayer Diagnostics (Tarrytown, New York) and Abbott Diagnostics (Abbott Park, Illinois) now also are developing new systems that employ PCR technology. Roche is developing a fully automated system for molecular diagnostics that will provide a turnaround time from receipt of sample to result delivery of three hours, and that will be capable of testing 100 patient samples per day.

In the future, a convergence of technologies for nucleic acid testing and proteomics is expected to occur, according to Lu, driven by a clinical need for information on both DNA/RNA and protein markers when performing a differential diagnosis, developing a prognosis, or selecting therapy. New platforms will be required that employ microarrays and microfluidics, allowing high throughput, multi-marker testing to be conducted cost-effectively.

A long-term goal, according to leading experts in genomics, is to develop technologies that can analyze the complete genome of an individual at a cost of $1,000.

An example of a new platform employing microfluidics with applications in molecular diagnostics was described at the Diagnostics Asia conference by Robert Hodges of STMicroelectronics (Geneva, Switzerland). The company has developed a new lab-on-a-chip microfluidics platform derived from technology used in inkjet cartridges.

The initial applications under development are integrated nucleic acid diagnostic devices for sepsis and influenza testing. The In-Check test platform includes a rapid PCR reactor that performs a typical amplification reaction in nine minutes combined with a 100-cell microarray with a sensitivity of 0.1 nanomolar. At present, a fully integrated version of the system is still in development, but the components of the system already exist.

STMicroelectronics said it expects to introduce a system for sepsis testing by the end of this year in partnership with a company that has developed a panel of sepsis markers. Such technology represents the next generation of diagnostics technology to meet the need for multi-marker molecular diagnostic testing systems that will enable clinicians to make productive use of emerging genomic and proteomic biomarker discoveries.

SiMEMS Pte Ltd. (Singapore) is another company that has developed microfabricated device technology with applications in clinical diagnostics. As discussed by Uppili Raghavan of SiMEMS at the conference, the company's microfluidic chips are designed for isolation and purification of genomic DNA, total RNA, bacterial DNA and viral RNA.

The chips integrate between 15 and 20 steps that require separate manipulations using conventional technology for nucleic acid extraction into a single device. The device can accept whole blood or other fluid samples having a volume of between 3 microliters and 400 microliters. A pre-concentration module also has been developed that allows larger sample volumes to be analyzed for targets that occur at very low levels such as organisms that cause sepsis when present at concentrations of one colony-forming unit per milliliter. Between 20 and 40 minutes are required to perform an extraction.

The company is targeting applications in point-of-care molecular testing, and plans to reduce the cost per chip from the present level of $12 to $17 down to $6 for specialized IVD testing. Raghavan said the company eventually expects to reduce the cost to about $4 per chip.

Attogenix Biosystems Pte Ltd. (also Singapore) has developed a chip-based nucleic acid diagnostic system with applications in infectious disease testing. The system consists of a PCR amplification chip, the AttoCycler, and a reader, the AttoChip. The first test to be introduced is a kit for detection of dengue virus, launched in late 2005.

Use of a microfluidic chip, including a novel self-sealing technology to prevent contamination, allows simplification of the testing process, reducing the number of pipetting steps from 20 for existing PCR formats to four, and enabling the test to be performed by technicians who do not have specialized training.

A sensitivity of 98% and specificity of 99% have been demonstrated in clinical trials. Cost per test is only SP$25 (about U.S.$15) vs. SP$50 for competing dengue kits employing nucleic acid diagnostic technology. The company is developing a multi-cartridge extraction system to enable automation of sample preparation. n

(Next week: Growth in pharmacogenetic testing, cancer diagnostics.)

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