WELLS BIO (United States)

WELLS BIO is an in vitro diagnostics (IVD) brand associated with the Access Bio group, with corporate addresses listed in Somerset, New Jersey, United States, and in the Magok district of Gangseo-gu, Seoul, Republic of Korea. The brand develops and manufactures diagnostic tests based on immunochemical, biochemical, and molecular diagnostic technologies, aiming to support early diagnosis of diseases. Its stated vision is to be "the world's best life-caring companion," delivering accurate and fast test kits for early-stage diagnosis. The product portfolio spans several categories. Under rapid diagnostic tests (RDT), the brand offers products such as careUS™ Strep A Plus, careUS™ Flu A&B Plus, careUS™ Rotavirus Plus, careUS™ RSV Plus, careUS™ HIV 1/2-T, careUS™ Scrub Typhus, and careUS™ MERS-CoV Ag. In biosensor diagnostics, it offers the careSTART™ S1 Analyzer and related strips, including G6PD, Hb, and Total Bilirubin strips, as well as the careSTART™ A1c Cartridge. In molecular diagnostics (Mol. Dx), it offers careGENE™ kits such as the STD-12 detection kit, HPV screening kit-H, HPV genotyping kit-O, Malaria Pf/Pv LDH kit, Dengue Virus RT-PCR kit, Zika Virus RT-PCR kit, and COVID-19 RT-PCR kits. The brand also lists HbA1c among its product areas. Regulatory milestones include KFDA and FSC acquisitions for numerous products between 2016 and 2022, including the careUS™ COVID-19 Antigen Home Test in February 2022 and the careUS™ MERS-CoV Ag in April 2022. The brand operates globally, with the Access Bio group maintaining a U.S. presence in Somerset, New Jersey, a Korean base in Seoul, and an Ethiopian branch in Addis Ababa. WELLS BIO presents itself as a global IVD company focused on innovative diagnostics for early disease detection.

WELLS BIO is an in vitro diagnostics brand operating within the Access Bio group. Its corporate footprint includes Access Bio, Inc. at 65 Clyde Road, Suite A, Somerset, New Jersey, United States; WELLS BIO, Inc. at 16, Magokjungang 8-ro 1-gil, Gangseo-gu, Seoul, Republic of Korea; and an Access Bio, Inc. Ethiopian Branch at Kebele 16, New Addis Ababa, Yeka Sub-City, Ethiopia. The brand's history page organizes its development into phases, with the period from 2016 onward described as a leap to become a global leading IVD company. Between 2016 and 2022, the brand accumulated a series of regulatory clearances and certifications. In 2016, it completed its Magok R&D center in August, and obtained FSC for careGENE™ Dengue Virus RT-PCR kit in November, KFDA for careUS™ Flu A&B Plus in September, FSC for careUS™ Rotavirus Plus and KFDA for careGENE™ Zika Virus RT-PCR kit in August, and FSC for careUS™ Scrub Typhus and careUS™ HIV 1/2-T in July. In 2017, it obtained KFDA for careUS™ Strep A Plus in August, KFDA for careUS™ Rotavirus Plus and CE for careSURE™ A1c Cartridge in July, NGSP for careSTART™ A1c Cartridge in June, IFCC for careSTART™ A1c Cartridge in May, and KFDA for careSTART™ A1c Cartridge in March. In 2018, it obtained KFDA for careUS™ RSV Plus in June and KFDA for careGENE™ HPV screening kit-H in May. In 2019, it obtained KFDA for careGENE™ STD-12 detection kit in April, FSC for careGENE™ Malaria Pf/Pv LDH kit in July, FSC for careSTART™ S1 Total Bilirubin Strip and careSTART™ S1 Hb Strip in September, and KFDA for careSTART™ S1 G6PD Strip, careSTART™ G6PD Biosensor Strip, and careSTART™ Biosensor 1 G6PD Strip in December. In 2020, it obtained FSC for careGENE™ N-CoV RT-PCR kit in March and FSC for careGENE™ COVID-19 RT-PCR kit in April. In 2021, it obtained KFDA for careUS™ COVID-19 IgM/IgG Ab in May, KFDA for careUS™ COVID-19 antigen in August. In 2022, it obtained KFDA for careUS™ COVID-19 Antigen Home Test in February and FSC for careUS™ MERS-CoV Ag in April. The brand's vision statement describes its mission as delivering innovative diagnostics with high technology for each and every life in need. It emphasizes responsibility for each life, providing accurate and fast test kits for early diagnosis, promoting welfare through quality products, and pursuing shared growth with employees, stockholders, and society. The brand positions itself as a global IVD company contributing to healthy lives through innovative technology and development.

• Completion of Magok R&D center

• Acquisition of KFDA for careUS™ Flu A&B Plus

• Acquisition of FSC for careGENE™ Dengue Virus RT-PCR kit

• Acquisition of KFDA for careSTART™ A1c Cartridge

• Acquisition of IFCC for careSTART™ A1c Cartridge

• Acquisition of NGSP for careSTART™ A1c Cartridge

• Acquisition of KFDA for careUS™ Strep A Plus

• Acquisition of KFDA for careGENE™ HPV screening kit-H

• Acquisition of KFDA for careUS™ RSV Plus

• Acquisition of KFDA for careGENE™ STD-12 detection kit

• Acquisition of FSC for careGENE™ Malaria Pf/Pv LDH kit

• Acquisition of KFDA for careSTART™ S1 G6PD Strip

• Acquisition of FSC for careGENE™ N-CoV RT-PCR kit

• Acquisition of FSC for careGENE™ COVID-19 RT-PCR kit

• Acquisition of KFDA for careUS™ COVID-19 IgM/IgG Ab

• Acquisition of KFDA for careUS™ COVID-19 antigen

• Acquisition of KFDA for careUS™ COVID-19 Antigen Home Test

• Acquisition of FSC for careUS™ MERS-CoV Ag

Global in vitro diagnostics (IVD) brand focused on early disease diagnosis through immunochemical, biochemical, and molecular technologies.

• Biosensor

  careSTART™ S1 Analyzer

• Molecular Diagnostics

  careGENE™ STD-12 detection kit

• Rapid Diagnostic Test

  careUS™ Strep A Plus

• Rapid Diagnostic Test

  careUS™ Flu A&B Plus

• Rapid Diagnostic Test

  careUS™ Rotavirus Plus

• Rapid Diagnostic Test

  careUS™ RSV Plus

• Rapid Diagnostic Test

  careUS™ HIV 1/2-T

• Rapid Diagnostic Test

  careUS™ Scrub Typhus

• Rapid Diagnostic Test

  careUS™ MERS-CoV Ag

• Rapid Diagnostic Test

  careUS™ COVID-19 Antigen Home Test

• Rapid Diagnostic Test

  careUS™ COVID-19 IgM/IgG Ab

• Molecular Diagnostics

  careGENE™ HPV screening kit-H

• Molecular Diagnostics

  careGENE™ HPV genotyping kit-O

• Molecular Diagnostics

  careGENE™ Malaria Pf/Pv LDH kit

• Molecular Diagnostics

  careGENE™ Dengue Virus RT-PCR kit

• Molecular Diagnostics

  careGENE™ Zika Virus RT-PCR kit

• Molecular Diagnostics

  careGENE™ COVID-19 RT-PCR kit

• HbA1c

  careSTART™ A1c Cartridge

• Biosensor

  careSTART™ S1 G6PD Strip

• Biosensor

  careSTART™ S1 Total Bilirubin Strip

• Biosensor

  careSTART™ S1 Hb Strip

1. 1WELLS BIO official websitewellsbio.net
2. 2WELLS BIO Historywellsbio.net
3. 3WELLS BIO Visionwellsbio.net
4. 4WELLS BIO Productswellsbio.net
5. 5Wikidata: WELLS BIO (United States)wikidata.org