HORIBA Medical offers comprehensive and high-quality clinical chemistry reagents of the POINTE brand. The POINTE brand has over 40 years of expertise in developing reagents and distribution, started in the United States. Discover how the POINTE reagents developed, meeting changing demands over decades, and will be offered paired with chemistry analyzers and service support in which HORIBA Medical has the strengths.
Triglycerides-GPO liquid reagent
Pointe Scientific began in 1981 with 14 clinical chemistry reagent products.
Pointe offered 12 dry powder, general chemistry reagents plus an amylase and lipase assays based on nephelometry. The dry powder chemistry reagents offered longer shelf-life and reconstituted stability than the lyophilized reagents commonly used at that time.
In 1982 and 1983 several simple liquid reagents were formulated to create a basic 19 test menu. In those early days, a formazan dye Triglycerides reagent along with a “phenol-free” cholesterol reagent were Pointe’s biggest sellers.
During the 1980’s further reconstituted stability improvements were made to the existing dry powder products along with the introduction of about 12 new reagents, along with their required standards and controls as the company’s business grew.
The growth was fueled by a combination of taking on several new regional dealers for the Pointe Scientific label; and establishing a few Original Equipment Manufacturing (OEM) business relationships.
Automated reagents for HDL cholesterol
The decade of the 1990’s brought significant change to Pointe Scientific.
The company moved from a 3,000 sq. ft. building in Detroit to a brand new 12,500 sq. ft. establishment in Lincoln Park, MI. Pointe introduced a very small, semi-automated analyzer, the Pointe 180. Highly successful, upgraded versions are still sold today.
The 1990’s also saw the movement away from dry reagents needing reconstitution to a complete line of ready-to-use Liquid Stable reagents. This fueled product expansion of approximately 24 new reagents, along with many special calibrators and control products. These included innovative products for Amylase and automated reagents for HDL and LDL cholesterol.
Business relationships continued to expand in this decade. Pointe continued to seek new dealers and OEM relationships both in the US and internationally. Two very significant OEM partnerships were established in Poland and China, along with several new international and US dealers.
Also contributing to the growth was the introduction instrument-specific packaging of reagents for the Hitachi series of chemistry analyzers.
Canton Facility (Michigan, US)
The decade of the 2000’s continued the significant development of Pointe Scientific.
In 2004 Pointe moved to its current 25,000 sq. ft. facility in Canton, MI.
A total of 16 new reagents were developed, with one of those reagents having a major impact on Pointe’s growth.
In 2003 Pointe received FDA clearance to introduce its unique, single channel assay for Hemoglobin A1c. The reagent was based on a novel approach to latex-enhanced immunoturbidimetric analysis that allowed determination of %HbA1c without assaying total hemoglobin.
Soon after, Pointe developed instrument applications to assay %HbA1c using on-board lysing of the red cells, eliminating the need for off-line, manual sample preparation, allowing complete automation of the assay.
The HbA1c reagent, with its procedural innovations, greatly expanded Pointe’s worldwide OEM presence, particularly in South America and Europe, along with a significant increase in distributors of Pointe Scientific’s complete line of reagents.
Pointe continued to grow its OEM and distribution network until 2013 when it was sold and merged to become MedTest Dx. MedTest Dx offered instrument service, LC/MS assays, in addition to a newly developed line of instrument-specific packaged reagents for Beckman Coulter AU instruments. MedTest also offered a benchtop, automated chemistry analyzer along with a variety of Drug-of-Abuse reagents, calibrators and controls.
In early 2021, HORIBA purchased MedTest Dx and resurrected the Pointe name along with a focus on research & development. Today, several new reagent products are under development, as well as some new chemistry analyzers Yumizen C560, Yumizen C240 and Yumizen C230.
Written by Bill Walters
Bill Walters works in the research and development department at HORIBA Medical US (HORIBA Instruments Incorporated). He specializes in new product development, drawing on his extensive clinical chemistry experience of over 35 years to develop new assays.
Bill Walters, R&D, HORIBA Medical US (HORIBA Instruments Incorporated)
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