A Diagnostics & Imaging Week
Given Imaging (Yoqneam, Israel), which describes itself as "the global leader in capsule endoscopy," said that Japan's Chuikyo — the Central Social Health Insurance Committee — has approved reimbursement for the company's PillCam SB capsule endoscope.
Effective Oct. 1, Japan's entire adult population will be eligible for reimbursement of the PillCam SB procedure for small-bowel indications with obscure GI bleeding. The announcement follows approval received from the Ministry of Health, Labor and Welfare (MHLW) in April to market and sell the PillCam SB capsule endoscope in Japan.
Homi Shamir, president and CEO of Given Imaging, said, "This ... means that patients in Japan who suffer from abdominal symptoms can now be diagnosed using PillCam SB, a proven patient-friendly, effective procedure. We are very pleased that Chuikyo issued its reimbursement decision well ahead of our expectations and will continue to work closely with our Japanese partners to educate gastroenterologists throughout the country and accelerate sales of PillCam SB.
Shamir said that Given will introduce the rest of its product line, including the PillCam SB 2, PillCam ESO 2, Agile patency and PillCam Colon into the Japanese market at some future point.
Given Imaging has operating subsidiaries in the U.S., Germany, France, Japan and Australia.
Calypte test okayed in India
Rapid HIV diagnostic test manufacturer Calypte Biomedical (Lake Oswego, Oregon) said it has received registration and marketing approval for its Aware HIV 1/2 OMT (oral fluid) rapid test in India from the Drug Control Authority of India (DCAI).
Roger Gale, Calypte chairman and CEO, said, "India is at the forefront in the fight against HIV/AIDS and we have seen strong interest in our oral fluid tests from both the government and private sectors. A Calypte team has just returned from India, where we have begun putting in place the infrastructure to access and build on this important business opportunity. We expect the market for HIV diagnostic testing in India to grow significantly in the next few years."
Gale termed the DCAI approval "a significant milestone in the advancement of our business; a very exciting time for all of us at the company. Once our non-invasive HIV diagnostic tests gain market acceptance, we anticipate significant growth in market share of such tests."
He said that in addition to creating a distribution network, Calypte plans to establish both research and manufacturing operations in India. "[It] is a logical center for development of Calypte's new products."
Gale said, "While we will initially enter the Indian market with our HIV 1/2 oral fluid rapid test, we are also considering introducing our Aware HIV 1/2 rapid tests using both blood and urine samples to complement the current oral fluid test."
According to 2006 estimates by the National AIDS Control Organization, India has an estimated 2.5 million HIV infections, ranking third behind South Africa and Nigeria for the highest number of HIV/AIDS-infected people. Naresh Dayal, secretary of health and chairman of the National AIDS Control Board, said, "We cannot be complacent. The steady and slow spread of the HIV infection is a worrying factor."
China Sky One gets 'Innovative' recognition
China Sky One Medical (Harbin, China), a manufacturer of diagnostic and pharmaceutical products, said it has been recognized as an "Innovative Enterprise" by the government of Harbin. With the recognition, it will receive an annual grant of RMB 4 million for the next three years, beginning last month and continuing through June 2010.
The company said the grant will support its new product R&D efforts.
Yanqing Liu, president/CEO of the company, said, "We are pleased to be the only consumer healthcare company in Harbin to be recognized as an Innovative Enterprise and we are delighted to receive the annual grant, which we will put to good use enhancing our new product pipeline."
The Harbin Science and Technology Bureau recently named 10 local companies Innovative Enterprises and offered them grant money in order to encourage innovation in the region.
The government also set aside RMB 6 million per company for future investment in the area.
New histology kit is launched by mtm
mtm laboratories (Heidedlberg, Germany), a cancer diagnostics company, has launched its CE-labeled CINtec Histology kit with extended claims in Europe. The company said the added clinical claims resulted from a recent pan-European pivotal study involving 15 pathologists from France, Spain, Italy and Germany.
The multi-center trial was conducted to determine the diagnostic accuracy of pathologists in reading H&E-stained cervical biopsies together with CINtec Histology-stained slides, compared to reading H&E slides alone. It involved some 500 retrospectively collected cervical tissue specimens.
Ruediger Ridder, mtm's chief scientific officer, said overall sensitivity for the detection of CIN2 and higher-grade disease was improved by 13%, with a 95% sensitivity for detection of high-grade CIN3 disease, while the number or false negative results dropped by 45%. "In addition," he said, "the inter-observer agreement, which is higher by 30%, improves the certainty that the result is consistent among different reviewers."