SAN DIEGO – QuidelOrtho, a San Diego-based diagnostic company and leader in infectious disease testing, has secured FDA clearance for its Vitros Syphilis Assay, marking its first major milestone since the appointment of its new CEO Brian Blaser.
The product which received the green light from the U.S. Food and Drug Administration, is expected to play a critical role in helping address the syphilis epidemic in the United States, according to the firm’s executives.
CEO
QuidelOrtho
“As an in-demand assay for a common sexually transmitted infection, we are pleased to offer the VITROS syphilis assay, bolstering QuidelOrtho’s infectious disease test portfolio in the U.S.,” said Bryan Hanson, president North American Commercial Operations at QuidelOrtho.
“Not only does this important assay improve laboratory efficiency by allowing labs to follow the CDC’s reverse testing algorithm for syphilis screening, it also reduces costs by providing earlier disease detection, thereby reducing the need to refer tests to outside labs,” he said.
Innovative Diagnostic Products
QuidelOrtho develops and manufactures diagnostic products that help health care professionals evaluate patients for infectious diseases, chronic conditions and in clinical research.
The publicly traded company’s offers a large variety of infectious disease tests on different platforms in different settings and with different technologies.
President, Commercial Operations
QuidelOrtho
This year, it is working to bring to market a next-generation RVP4+ assay that it expects to be commercially available in 2025.
It is committed to building a menu for the platform with the highest-quality assays, and recently collected nine-month data for the four viruses targeted by the RVP4+ test “initially showed great promise.”
The test is expected to be a key sales driver for the company’s Savanna PCR platform, according to industry analysts at William Blair.
“This is a required assay to help drive a meaningful number of platform placements,” wrote analyst Andrew Brackmann in an email.
Hiring New CEO
In May 2024, appointed former Abbott executive Brian Blaser as new chief executive officer. Blaser spent time at Eastman Kodak and Johnson & Johnson before joining Abbott.
Blaser, said the company is leaving “no stone unturned” as it seeks to cut operating expenses and improve profit margins.
“We are in the early stages of improving our overall business efficiency with initiatives in procurement, supply chain, manufacturing quality and IT,” said Blaser. “And finally let me reiterate that the underlying health and fundamentals of our business remain intact. We are focused on challenging every aspect of the business to improve our performance, while balancing the needs to invest for future growth.”
In May 2020, Quidel received the first emergency use authorization from the U.S. Food and Drug Administration for its at-home COVID-19 antigen test. The company’s revenue initially jumped but then later slowed as the pandemic ended and demand for tests dropped.
Quidel changed its name to QuidelOrtho in 2022 after the $6 billion acquisition of Ortho Clinical Diagnostics Holdings to diversify its diagnostics portfolio.
Optimistic on Next Chapter
Headquartered in San Diego and manufacturing facility in Carlsbad. It has 7,100 employees worldwide, with 4,200 workers based in the United States.
With the recent change in leadership, it is well-positioned to drive growth and deliver exceptional value to our customers, according to its executives.
Over next twelve months it is focused primarily on enhancing its local production facilities, investing in new technologies and expanding into new markets.
“As we look ahead to the rest of 2024 and beyond, there are several key initiatives and developments that we are particularly excited about,” said Hanson. “For instance, we are looking at opportunities to add new tests to our menu, such as syphilis, to complement our existing herpes simplex virus and varicella-zoster virus (HSV/VZV) assay on our Savanna Real-Time PCR Testing Platform.”
“These additions would address a critical need and open new avenues for us, potentially creating new market opportunities,” said Hanson.
QuidelOrtho
FOUNDED: 2022
CEO: Brian Blaser
HEADQUARTERS: Mira Mesa
BUSINESS: Provider of diagnostic tests and equipment
REVENUE: $3 billion in 2023
STOCK: QDEL (Nasdaq)
WEBSITE: www.quidelortho.com
NOTABLE: Quidel, the San Diego precursor to QuidelOrtho, was founded in 1979 by Dr. David H. Katz and launched its first products – pregnancy tests – in 1983. Ortho was established in 1939 in New Jersey as a division of Johnson & Johnson.
