Company Update (NASDAQ:ILMN): Berry Genomics NextSeq CN500 Instrument and Non-Invasive Prenatal Testing Reagent Kit Receives Chinese FDA Premarket Clearance


Berry Genomics Co., Ltd. announced today that Hangzhou Berry Genomics, a subsidiary of Berry Genomics Co., Ltd., has received premarket clearance from the Chinese Food and Drug Administration (CFDA) for the NextSeq CN500, a high throughput sequencing instrument developed with Illumina, Inc. (NASDAQ:ILMN) to meet Chinese clinical needs. Hangzhou Berry Genomics also received premarket clearance for its non-invasive prenatal testing (NIPT) detection kit for trisomies 13, 18 and 21.

The NextSeq CN500 utilizes Illumina’s sequencing by synthesis technology and was designed for operations in a clinical setting. Complementary with NextSeq CN500, Berry Genomics’ NIPT kit is based on a proprietary PCR-free protocol, which simplifies the complex NIPT sample preparation process to a two-step workflow in a single tube. The system can process up to 96 samples per instrument run.

“From original conception in 2007 to its current IVD products, NIPT has gone through an adoption process with unprecedented speed. Thanks to the tremendous support provided by the Chinese government and clinicians, China today is at the forefront of NIPT development,” said Daixing Zhou, Chief Executive Officer of Berry Genomics. “Illumina’s market-leading sequencing technology has earned its place as the gold standard in the industry. By being able to partner with Illumina to develop and deliver an instrument that is suitable for Chinese clinical laboratories, we hope to serve the Chinese population with the most advanced technologies available in the world.”

“We are excited about the premarket clearance of the NextSeq CN500 by the CFDA,” said Tristan Orpin, Senior Vice President & General Manager, Reproductive and Genetic Health, of Illumina. “We value the relationship with Berry Genomics, a leader in NIPT in China, and are honored to make contributions to improve the health of the Chinese population. We will continue collaborating with Berry Genomics to deliver the gold standard in sequencing-based clinical applications to the market.”

 (Original Source)

Shares of Illumina closed yesterday at $187.62 . ILMN has a 1-year high of $213.33 and a 1-year low of $127.69. The stock's 50-day moving average is $194.50 and it's 200-day moving average is $185.59.

On the ratings front, Illumina has been the subject of a number of recent research reports. In a report issued on February 2, Cantor Fitzgerald analyst Sung Ji Nam maintained a Hold rating on ILMN, with a price target of $166, which represents a potential downside of 11.5% from where the stock is currently trading. Separately, on January 28, Credit Suisse's Vamil Divan reiterated a Buy rating on the stock and has a price target of $230.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Sung Ji Nam and Vamil Divan have a total average return of 13.5% and 32.8% respectively. Nam has a success rate of 88.2% and is ranked #518 out of 3560 analysts, while Divan has a success rate of 80.0% and is ranked #128.

The street is mostly Bullish on ILMN stock. Out of 7 analysts who cover the stock, 6 suggest a Buy rating and one recommend to Hold the stock. The 12-month average price target assigned to the stock is $231.83, which represents a potential upside of 23.6% from where the stock is currently trading.

Illumina Inc providessequencing-and array-based solutions for genetic analysis. Itsproducts enabled researchers to explore DNA, helping them create the first map of gene variations associated with health, disease, and drug response.

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