CHICAGO — MP Biomedicals (Singapore) has launched rapid tests for two highly contagious and rapidly spreading diseases. Dengue virus and tuberculosis (TB) infect literally millions of people each year and result in millions of deaths.
"FastSure TB DNA molecular rapid test is the first ever rapid test," Samson Chen, MD director of sales and marketing, MP Biomedicals Asia Pacific, said at the American Association for Clinical Chemistry's (AACC; Washington) annual meeting.
"With Assure Dengue IgA Rapid test, we seek to fill the gap that definitely exists in the current dengue diagnosis," said Bijon Kumar Sil, R&D director, MP Biomedical Asia Pacific and lead inventor of the test. "This is a significant step in dengue diagnostics, more so when you consider the scenario. Dengue treatment is merely supportive; there are no signs of preventive vaccination in the immediate future."
The Centers for Disease Control and Prevention (CDC; Atlanta) reports that nearly nine million people around the world become sick with highly contagious TB each year with two million TB-related deaths. And it's estimated by the World Health Organization (Geneva) that dengue, which is spread via mosquitos, infects 50 million people annually.
"PCR shows good results when testing for TB, but there's a high cost associated and you need highly trained lab technicians," Chen said. "FastSure TB DNA is more economical and more accurate."
AFB smear and culture test is the current gold standard to diagnose TB. When FastSure TB DNA was compared in tests, it produced 96% sensitivity and 98.8% specificity.
For the user, the test requires a very small sample to be placed in a cartridge, which is then inserted in the handheld device. Results are observed with either a line or not, similar to a pregnancy test. Chen said this ease of use is critical in places of the world where trained lab technicians aren't available. Results are available within two hours.
"Relatively newer technologies such as PCR are promising but they can have their own challenges in terms of higher capital expenditure, need of specialized manpower and they're not easily available in underdeveloped and developing countries," Chen said.
The dengue test, the company reports, is the very first of its kind.
The Assure Dengue IgA Rapid Test is a reverse flow immuno-chromatographic rapid test for qualitative detection of anti-dengue IgA antibody in whole blood, serum or plasma.
The dengue test produces results with an indicator line similar to the TB test and results are available in 20 minutes.
In other news from the conference:
• Abbott (Abbott Park, Illinois) reported that a diagnostic marker, human epididymal protein 4 or HE4, combined with other tests, can be used to more effectively monitor for early stage ovarian cancer (EOC), improving treatment options for many of the 22,000 women in the U.S. who develop the deadly disease each year.
New research on HE4 presented by Richard Moore, MD, associate professor in the Program for Women's Oncology at Women and Infants' Hospital/Brown University, at a scientific workshop hosted by Abbott, provided validation for the use of the HE4 test in combination with CA125, the current standard for monitoring ovarian cancer, in estimating EOC risk in women presenting with pelvic masses.
The HE4 test was developed through research efforts aimed at identifying combinations of biomarkers to add sensitivity to the CA125 test, which is limited in its sensitivity and specificity, as well as its ability to monitor early EOC.
"Our results show that the dual marker combination of HE4 and CA125 can aid in the differentiation of benign pelvic masses from ovarian malignancies in women diagnosed with a pelvic mass," said Moore. "This is exciting as it will help us improve the care we give to the many women who are afflicted by this deadly disease."
• Fujirebio Diagnostics (Malvern, Pennsylvania) and Abbott have signed a license agreement to develop this new ovarian cancer marker for use on Abbott's automated Architect diagnostic analyzers. A manual form of the HE4 test has been approved by the FDA as an aid in monitoring recurrence or progressive disease in patients with EOC and is CE marked for use within the European Union.
• AMDL Diagnostics (Tustin, California) introduced AMDL's FDA-approved non-invasive Onko-Sure in vitro diagnostic (IVD) blood test that enables physicians and their patients to effectively monitor and/or detect solid tumor cancers, including colorectal cancer, by measuring the accumulation of specific breakdown products in the blood called fibrin and fibrinogen degradation products.
AMDL Chairman/CEO Douglas MacLellan said, "Since AMDL Diagnostics began commercializing its Onko-Sure IVD cancer test we've seen substantive market demand both as a CRC monitoring test and a pan tumor cancer screen. This is positive news for the company in that selling Onko-Sure in the U.S. as a CRC monitoring test and expanding the application of the test as a pan tumor marker internationally offers greater market penetration and revenue upside. On tests sold to IVD distributors ranging from $50 per test per patient for CRC and up to $150-$250 per test per patient as a pan tumor screen we expect a gross profit margin above 90%. Our top priority is to continue signing strategic distributor partners that will enable us to achieve our market share targets."