DiFei Gene Sequencer was approved for launch, with strong layout for compliance implementation in the hospital

Recently, Nanjing Difei Medical EquipmentThe DIFSEQ-200 high-throughput gene sequencer produced by the company has been approved by the State Food and Drug Administration for marketing.

DIFSEQ-200 is a compact and flexible desktop gene sequencer that uses combined probe-anchored polymerization technology and DNA nanosphere sequencing technology.It is suitable for the entire ecosystem of genetic testing, including prenatal screening, tumor diagnosis, and pathogen identification.

1. High sequencing quality, Q30≥85%

2. Supports multiple read lengths to meet the needs of 10-150G diverse scenarios

3. Suitable for a variety of clinical sample types such as tissue, blood, sputum, cerebrospinal fluid, etc.

The DIFSEQ-200 sequencer took nearly 3 years from product establishment to approval for marketing, and included a total of 878 clinical samples.Successfully passed the verification of 6 types of representative clinical projects and performed well in sequencing capabilities.It contains 4 types of infection-related items:

1. Virus identification and typing

Taking the nucleic acid typing test project of human papillomavirus (types 16 and 18) in 136 cases of cervical epithelial exfoliated cells as an example, the positive and negative coincidence rates of virus typing were both 100%.

2. Resistance gene detection

Taking the rifampicin resistance detection project of sputum Mycobacterium tuberculosis in 147 cases as an example, the positive coincidence rate and negative coincidence rate of H526Y and S531L mutation detection were both 100%.

3. Throat swab pathogen detection

Taking the Mycoplasma pneumoniae detection project of 151 cases of throat swabs as an example, the positive and negative coincidence rates for pathogen identification were both 100%.

4. Blood pathogen testing

Taking the 151 peripheral blood cytomegalovirus testing items as an example, the positive and negative coincidence rates for pathogen identification were both 100%.

The approval of Diffei's DIFSEQ-200 sequencer has given a boost to the implementation of Diffei's pathogenic hospital compliance.Paired with a fully automatic pre-processor, nucleic acid extractor, library workstation, and Genesis all-in-one bioinformatics analysis machine, Diffei can provide a modular and integrated in-hospital solution.Cooperating units can carry out in-hospital testing of mNGS and tNGS based on actual needs, and issue personalized reports based on patient clinical information to guide the rational use of antibacterial drugs.

Today, DiFei is leading the industry's compliance development; in the future, DiFei will rely on DIFSEQ-200 to provide professional and real-time services such as technology implementation, personnel training, and quality management to cooperative units, and work together to build a 'Healthy China'.