Vol.256 | Weekly Highlights of IVD and Precision Medicine Industry and Investment

Sep 06, 2024 14:42 CST Updated 14:42

Abbott

Provider of Health Diagnostic Products and Health Diagnostic Management Solutions

Medtronic

Medical Device Manufacturer

TARGETING ONE

In Vitro Diagnostics Product Developer

New National Standard Added for IVD, Matters Significantly!

National Standard "Molecular In Vitro Diagnostic Tests - Specification for Pre-Examination Processes of Formalin-Fixed and Paraffin-Embedded Tissue - Part 4: In Situ Detection Techniques" (GB/T 42216.4-2024) Officially Released

Abbott Alinity i Chemiluminescence Analyzer Made in China

Officially Obtain Chinese Domestic Identity!

On September 3, 2024, Albot BioMedical (Hangzhou) Co., Ltd. (hereinafter referred to as Hangzhou Albot) received the "Alinity i Fully Automatic Chemiluminescence Immunoassay Analyzer Product Registration Certificate" delivered by the Zhejiang Provincial Drug Administration. This marks the successful implementation of Hangzhou's first imported medical device localized production project and signifies that the localization of a multi-sample fully automatic rapid testing platform in Hangzhou has become a reality.

Heavyweight! The world's first Class III certificate!

Recently, the human immunodeficiency virus type I (HIV-1) DNA detection kit (PCR-fluorescence probe method) independently developed by Guangzhou Hailite Biotechnology Co., Ltd. has obtained the Class III "Medical Device Registration Certificate" issued by the National Medical Products Administration (NMPA). The approved HIV-1 DNA load detection kit features extremely high specificity and sensitivity and can cover HIV-1 subtypes prevalent in China.

Medtronic Chief Medical Officer Jumps to IVD Company!

Medtronic Acute Care and Monitoring (ACM) Chief Medical Officer Dr. Sam Ajizian announced on LinkedIn that he will be leaving the company. On August 30, Ajizian updated on LinkedIn that he would assume the role of Chief Medical Officer at Inflammatix. Public information shows that Sam Ajizian holds a medical degree from the University of Southern California, completed his pediatric residency and served as chief resident at Children's Hospital Los Angeles. Subsequently, he joined the U.S. Air Force, serving as a pediatrician and flight surgeon in an F-16 squadron.

17.04 Million Grant! Promoting Syphilis Testing R&D

The National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), announced on September 3, 2024, that it has awarded a total of $2.4 million (approximately 17.04 million RMB) in 10 grants to develop new diagnostic devices and methods for detecting syphilis infections. These projects aim to streamline the testing process, thereby accelerating public health responses to congenital and adult syphilis.

TARGETING ONELung Cancer EGFR Liquid Biopsy

Digital PCR Kit Approved for Marketing

On September 2, TARGETING ONE's "Human EGFR Gene Mutation Detection Kit (Digital PCR Method)" obtained the Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA). This is another digital PCR diagnostic reagent approved for marketing by TARGETING ONE following the approval of its digital PCR-based COVID-19 nucleic acid detection reagent in 2022.

IVD Company Shenzhen Jinzhun Biomedical Engineering Co., Ltd. Completes Tens of Millions in Financing

Recently, Shenzhen Jinzhun Biomedical Engineering Co., Ltd. successfully completed a C-round financing of tens of millions of yuan, with investment from Guangdong Yuecai SME Equity Investment Fund Partnership (Limited Partnership). Jinzhun Biomedical is a national high-tech enterprise dedicated to the research, development, production, sales, and service of in vitro diagnostic (IVD) reagents and instruments.

IVD Raw Material Company Secures €600 Million in Financing

Helsinki, Finland, September 3, 2024 – DevCo Partners Oy is pleased to announce that it has secured total commitments of EUR 616 million for the Medix Biochemica dedicated long-term single-asset investment platform. As part of this transaction, approximately EUR 300 million of new investments have been injected into the investment platform, providing DevCo with substantial additional capital to continue supporting Medix Biochemica’s long-term growth strategy.

Milestone!

Chinese IVD Giant Obtains US CLIA Lab Certification

Oriental Biotech announced that its wholly-owned subsidiary, Texas Science, has recently obtained the CLIA certification issued by the U.S. CMS, valid from August 11, 2024, to August 10, 2026. This certification allows the laboratory to accept and analyze clinical samples during the validity period, facilitating Texas Science in conducting relevant research trials and testing services in the United States, further enhancing its market presence.

IVD Company Raises 1 Billion in Financing!

September 4, 2024 – BillionToOne announced that it has signed a $140 million (approximately 1 billion RMB) non-dilutive financing agreement with Oberland Capital Management. BillionToOne is advancing a technology that uses so-called quantitative counting templates to precisely quantify DNA molecules. The company stated that, to date, it has provided testing for more than 500,000 patients. Its first test is the Unity fetal risk screening, which analyzes fetal DNA in parental blood to test for aneuploidy and common recessive conditions such as sickle cell disease, spinal muscular atrophy, and cystic fibrosis.

German Bioinformatics Company

Seed Round Financing of $1.4 Million for Rare Disease Diagnosis Research

Lucid Genomics Raises €1.3M in Pre-Seed FundingGerman Bioinformatics Startup Lucid Genomics Secures €1.3M ($1.4M) in Pre-Seed FundingThe company said in a statement that it would use the funds to expand its software-as-a-service platform for extracting genomic information to improve diagnostics and drug discovery.The initial focus will be on rare genetic diseases, followed by cancer diagnosis and other related fields.