A Medical Device Daily

BioCurex (Richmond, British Columbia) said it has completed a study in which its Recaf blood test detected 92% of cervical cancers using a drop of blood. The specificity of the test was 95.7%.

The study included 25 cervical cancer blood samples and 69 normal blood samples, BioCurex said.

BioCurex’s technology identifies a cancer marker known as Recaf, which is found on malignant cells from a variety of cancer types but is absent in most normal or benign cells.

The company said that the National Cancer Institute (Bethesda, Maryland) reports a sensitivity of 55% to 88% for detecting high-grade lesions using a traditional Pap test.

The estimated market size for Pap smears is $1 billion for 2005. Currently, there is no commercial blood test available for the detection of cervical cancer.

BioCurex CEO Dr. Ricardo Moro said the findings “are in line with our previous results for detecting other types of cancers. The accumulation of positive results strongly suggests that Recaf is expressed by all types of cancer, thus lending additional support to the idea of using this cancer marker for routine cancer screening.”

He added that a Recaf test performed on blood collected for other routine clinical analysis “would likely prove much cheaper than the traditional Pap test, which currently involves a gynecologist to extract the sample as well as a pathologist (or a sophisticated artificial intelligence system) to read the results.”

Moro said another important application for BioCurex’s blood test is “to improve the follow-up screening of patients who have been operated on for cervical cancer; recurrence of the cancer or its metastases could be detected early by periodically monitoring the blood levels of Recaf, thereby significantly enhancing the chances of patient survival.”

Worldwide, cervical cancer claims around 190,000 lives annually, the company said, and is the third-most-common cause of cancer-related deaths.

Nigerian contract for MSI test kits

Medical Services International (MSI; Edmonton, Alberta) said it has been awarded a $25 million contract from the government of Nigeria for its VScan HIV 1 & 2 test kits.

Nigeria recently issued a tender notice for eligible companies to submit proposals to supply its health sector with HIV test kits. That procurement contract was an up-shot of the $120 million loan recently awarded to Nigeria from the World Bank for improvement of the country’s health, educational and agricultural sectors. Of the $120 million, $25 million was allocated for the supply of HIV/AIDS test kits.

The VScan HIV test kit had recently been awarded registration and approval in Nigeria.

MSI also reported that its VScan HIV and TB rapid test kits have been accepted for registration by regulatory authorities in Russia.

The company noted that the Doctors Without Borders organization had reported last month that development of simple and rapid diagnostic tools is the key to fighting tuberculosis. The organization said that TB would kill more than 8 million people this year, more than all other infectious diseases combined.

MSI said that it is receiving “increasing interest” in its VScan TB test kit, and that it expects to generate more than $12 million in TB sales kit sales per year.

The company’s VScan rapid test kit is a single-use test for the screening of HIV 1 & 2, hepatitis B & C, tuberculosis, Dengue fever, West Nile virus, syphilis and prostate cancer.

Skin test device approved in China

Greer (Lenoir, North Carolina) reported receiving approval from China’s State Food and Drug Administration for the GreerPick Skin Testing System.

The GreerPick system, which the company said is used by more allergists in the U.S. than any other single-site skin test device, becomes the first device of its kind registered in China.

Skin testing is a primary tool for the diagnosis of inhalant allergies. The company said use of the GreerPick test provides “a very reliable and efficient method of skin testing.” It said the easy-to-use system is designed to protect skin test technicians from accidental needlesticks.

“We are very excited about the approval of the GreerPick in China because it gives Greer entry into one of the fastest-growing markets in the world,” said William Mahoney, director of source materials. “Currently most skin testing in China is performed by the intradermal method and the use of the GreerPick will allow skin testing to be performed much more quickly and safely.”

Greer is a provider of allergy immunotherapy products and services.

Mexican hospital installs Trestle solution

Trestle Holdings (Irvine, California), a supplier of digital imaging and telemedicine applications, said that the American British Cowdray Medical Center (ABC; Mexico City), one of the largest private hospitals in Mexico, has installed Trestle’s Internet-microscopy solution in its facilities as part of the organization’s expansion to new locations.

In late 2004, ABC expanded to a new campus in the popular suburban area of Santa Fe, which the organization termed the “most advanced medical facility in Latin America.” ABC Medical Center chose Trestle’s MedMicro web-based, slide-viewing system, which enables medical personnel to view digital images of patients’ specimens from anywhere, via the Internet, with a standard PC.

Physicians in different locations can view a patient’s slide simultaneously and collaborate in real time, Trestle said.

ABC Medical Center purchased MedMicro through Ad Astra International (AAII), a distributor of telehealth solutions. Trestle has a non-exclusive sales-agent relationship with AAII, which operates throughout Mexico and Central America.