According to public information, CellSearch is a brand new product developed by Johnson & Johnson to count and analyze circulating tumor cells (CTC). It is the world's first and only commercial product approved by the US Food and Drug Administration (FDA) and China's State Food and Drug Administration (CFDA) for the detection of malignant disease management.
"China Business News" reporter was informed that CellSearch officially sold in China in 2013, by the end of 2015, sales of hundreds of units in three years, the system sales unit price of about 4 million yuan. The actual detection volume of the system introduced to the hospital is not satisfactory. The average annual detection volume of the six or seven hospitals in Beijing is only one or two hundred.
Professionals told reporters that the technical flaws in the CellSearch system are destined to be marginalized by the market. CellSearch not only has limited antibody capture methods, but also does not enable live cell capture and subsequent genetic testing and medication guidance.
The reporter sent a letter to Johnson and Johnson, and interviewed CellSearch for suspension of production and sales. The relevant person replied that "(the product) is neither the pharmaceutical department nor the equipment department. It has been sold, not Johnson & Johnson products." Further explanation.
However, all the agents and medical institutions interviewed by this reporter indicated that this product is a Johnson & Johnson brand; some agents said that it is Johnson & Johnson's sales team.
Suspended production for half a year
Regarding the suspension of production of Johnson & Johnson CellSearch, our reporter consulted several sales agencies.
“It’s almost half a year after we stopped production. We stopped selling since the beginning of this year,†said a person from CellSearch’s sales agent, Beijing’s sales manager. The agent also said that the suspension of production and product quality has nothing to do with, "factory has its own considerations, is a market problem."
Agent Chuangbo Global Biotech sales staff confirmed that "CellSearch has been discontinued for some time, the specific reason is not explicitly stated, but it is estimated that there is a reason, otherwise it will not stop." Sales staff said that Johnson & Johnson said that it will be produced in two years. Upgrade new products.
According to its introduction, CellSearch has entered hundreds of institutions across the country, mostly hospitals, as well as individual research units. “The top hospitals in first-tier cities and capital cities have basically entered,†the source said.
According to the introduction of China Medical Device Information, No. 10, 2012, CellSearch is a brand-new product for counting and analyzing circulating tumor cells (hereinafter referred to as “CTCâ€), which was developed by Johnson & Johnson. It is the world's first and only commercial product to be tested for circulating tumor cells (CTC) approved by the FDA (approved in 2004) and CFDA (approved in 2012) for the management of malignant tumors.
According to the professional, CTC circulating tumor cells refer to tumor cells that are released from the solid tumor or metastases and enter the peripheral blood circulation spontaneously or because of the diagnosis and treatment operation.
In September 2012, at the press conference on CTC China research and cellsearch held in Beijing, Johnson & Johnson made such a recommendation to CellSearch: “There is such a cell that attracts attention – circulating tumor cells (CTC); One type of detection has received much attention - Johnson & Johnson (China) CellSearch detection system; more such a group of sounds shocking and listening - the scientific fortune of cancer patients, is possible!"
Johnson & Johnson said the CellSearch system is a proprietary technology of Veridex (Johnson & Johnson), the first and only approved CTC test in China, and CFDA approval to make China outside the US and the European Union. In the seventh country, CellSearch is allowed to monitor clinically assisted patients.
According to media reports, with the CellSearch system, as little as 7.5 ml of blood samples can be detected as low as a single CTC from more than 40 billion blood cells. Oncologists can use this information in conjunction with other diagnostic tests and clinical methods to assess the overall prognosis of patients and predict progression-free survival and overall survival. This test can be performed at any time to facilitate continuous monitoring of such cancer patients. In Europe, CellSearch has also been identified as an effective diagnostic test tool.
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