One for a while. In January 2019, the JP Morgan Medical Conference was held in San Francisco as scheduled. At this conference, known as the "Super Bowl for Biomedicine," a huge amount of biomedical technology transactions can be reached between the intertwined and several handshakes.

The 37th J. P. News from the Morgan Healthcare Conference

Then yesterday's giant drug companies will gather, and then the arterial network will be presented by Kaijie, Illumina, Guardant Health, 10X and other molecular diagnostic companies.

Kaijie: Acquisition and new product release, digital PCR, tuberculosis detection, bioinformatics, sample preparation

Qiagen launched a number of new products on the first day of JPM and announced the company's acquisition plan. The company announced that it will maintain its position as one of the most diversified life science research and molecular diagnostic companies.

Kee CEO Peer Schatz said the company plans to build a digital diagnostic system based on the digital PCR core technology acquired from Formulatrix. At the same time, develop a hand-held tuberculosis detection device, QuantiFeron-TB Gold Plus, and promote it to the world's resource-poor regions to detect tuberculosis.

The company disclosed that they have now acquired N-of-One to provide decision support for tumor molecular diagnostics by supplementing the bioinformatics platform. The company also introduced QiaCube Connect, a new product in the next-generation laboratory automated sample processing system.

Digital PCR

For a long time, Kaijie is a leader in the real-time PCR market, and digital PCR is an area that the company has not been involved in. This situation will change with the acquisition of Formulatrix by Kaijie.

Formulatrix, a Boston-based company, has developed a low-cost, tablet-based digital PCR system Constellation. The system will present a compromise between high-priced droplet digital PCR systems and traditional flat-panel real-time PCR.

Kaijie has not disclosed the financial details of the acquisition, but only said that the transaction will be completed in mid-2019. They are currently awaiting approval from regulators and the corresponding products are expected to be launched in 2020.

Schatz said that Kaijie has been observing the development trend of digital PCR in the past few years, which they consider to be the most attractive and growth segment in the life sciences. He said that the market for digital PCR is still small, ranging from about $150 million to $250 million, but the growth trend is obvious, currently accounting for about 10% of the overall market. The market for real-time PCR is about $2 billion.

Kaijie began working with Formulatrix a few years ago, and Schatz said that Formulatrix's microtiter plates are perfectly compatible with Kaijie's PCR products, making their sample integration workflows smoother.

He pointed out that Kaijie hopes that the digital PCR platform will reduce the workflow time limit from the current 300 minutes to 90 minutes. Although the product can only be used in research fields at first, digital PCR technology is slowly penetrating into the molecular diagnostics market, and Kaijie will also adapt to the current situation.

Tuberculosis test

Another R&D program is handheld TB testing equipment, and Kaijie is working with the Australian company Ellume, which will receive approximately $15 million in investment from Kaijie.

The current tuberculosis testing market accounts for only about 20% of the overall market, but this market is very important. In order to participate in national screening programs, companies must have diversified solutions that not only meet the needs of central laboratories, but also consider how to detect TB in under-resourced settings. Schatz said that about 85% of tuberculosis occurs in resource-poor areas, and there is strong evidence that tuberculosis control is the most difficult in this area.

“Now, with the leading technology of QuantiFeron, we are launching devices that can hold and use batteries, which will be a real breakthrough in the tuberculosis testing market.”

The company noted that the QuantiFeron technology enables the device to perform inspections in one go. This device can detect tuberculosis through blood samples. Usually, a single test needs to be prepared for 16-24 hours. The test results will be displayed on a real-time integrated display equipped with battery and USB interface functions and independent of the computer. The generated data can be stored and called again if needed.

Kaijie revealed that the product is expected to be launched in 2020.

Sample preparation and informatics

Kaijie also launched the next-generation laboratory automated sample preparation system QiaCube Connect and acquired a bioinformatics company, N-of-One.

QiaCube Connect is the next generation of Qiacube's existing laboratory sample preparation system, QiaCube, which currently covers approximately 8,000 laboratories worldwide. A new generation of products simplifies the use of processes and increases productivity. Specifically, the system automates the decomposition, binding, washing, and elution steps.

Importantly, the new system is fully connected to the new digital flatbed PCR system and is compatible with more than 80 existing suites and more than 3,000 protocols. Schatz revealed that earlier versions of the new system have been tested by some of the company's customers, and the company is looking forward to new customers.

Kaijie intends to add a lot of realistic evidence to his own literature-based interpretation through the acquisition of N-of-One, and to add more software and automated knowledge base methods.

“With a $70 million transaction in bioinformatics, Kaijie has secured the top spot in the field.” The addition of N-of-One will allow Kaijie to further expand its target group, such as insurance providers. , pharmaceutical companies, etc.

Earlier in 2018, Roche announced the acquisition of Flatiron Health to add real-world evidence for its oncology drug development efforts. Perhaps this means that the linkage between the real world and the knowledge base will become a trend.

Schatz said: "In the long run, the key to future differentiated competition may not be technology, but information science."

Illumina: Launches NovaSeq's new chip, iSeq suite, to develop the oncology and reproductive health business

Illumina announced that it will launch the NovaSeq next-generation chip in the first quarter of 2019 and upgrade the ISeq suite, but the company has not yet introduced a new sequencer.

In addition, Illumina plans to continue to expand the clinical market space, said its president Francis DeSouza, the company has launched a research version of the TruSight Oncology 500 analysis system, and plans to launch a clinical version. The expansion board for VeriSeq NIPT analysis will also be available in the first half of 2019.

In the first quarter, Illumina will also introduce the iSeq series of kits for 250 base-pair reads, with a 1.7x yield increase and a 20% price drop.

DeSouza also mentioned that the company's revenue in the fourth quarter of 2018 rose 11% year-on-year, about $865 million. Annual revenue increased 21% year-on-year to approximately $3.3 billion.

In the future, Illumina will continue to expand the company's influence in the clinical field, continue to seek regulatory approval for its clinical instruments, and develop clinical analysis products. DeSouza revealed that in August 2018, after MiSeqDx was approved by the State Drug Administration in China, Illumina opened a partnership with the oncology diagnostic company KingMed Diagnostics and a Chinese genetic disease company.

DeSouza also said that the company has launched the Trusight Oncology 500 test for research and pharmaceutical companies. The Pan-Cancer DNA and RNA team includes detection of tumor mutation load and microsatellite instability, which are increasingly recognized as important markers of immunotherapeutic response.

The current version of the Illumina TSO 500 test is used for formalin-fixed paraffin-embedded samples. But DeSouza said that Illumina is working with pharmaceutical partners to develop a version that works in the blood.

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