Note: The story mistakenly said that Sentinel's clinical chemistry assays run on instruments from Thermo Fisher. The error has been corrected.
NEW YORK – With two new SARS-CoV-2 diagnostic kits hitting the market, Milan-based Sentinel Diagnostics is looking to expand into the US market and continue its partnerships with major US companies.
The business-to-business diagnostics firm announced availability of its STAT-NAT COVID-19 assays, freeze-dried ready-to-use RT-PCR mixes, recently and is currently mapping out its distribution plans for the US, a spokesperson said. The tests can detect the coronavirus in 90 minutes, and there are two versions – one based on the Hong Kong protocol, called the STAT-NAT COVID-19 HK kit, and one based on the Berlin protocol, called the STAT-NAT COVID-19 B kit.
Having two independent kits allows end users to test with one kit and verify their results with the other, said CTO Maurizio Gramegna, since the coronavirus can modify sequences. The tests were developed using the publicly available genome sequences from the World Health Organization, he added. "We are sure that, so far at least, we are able to detect all the SARS-CoV-2 that is active," Gramegna said. The tests were validated on BioRad Laboatories' CFX96 real-time PCR instrument and Thermo Fisher Scientific's QuantStudio 5 real-time instrument, and, said Sentinel Head of Marketing Mario Fangareggi in an email, the validations will soon be extended to more platforms.
Sentinel is finalizing analytical and clinical validation of both tests and has contacted Italian regulators to include the company's tests in the list of approved diagnostics. Unlike in the US, there is no accelerated process to obtain regulatory clearance in Italy as a result of the outbreak, requiring Sentinel to use traditional bureaucratic channels to get its tests approved. Fangareggi said the company expects CE-IVD authorization for its tests on March 31. The company also said it is working with different Italian reference centers to commercialize the test in Italy and collaborating with distributors to make the test available worldwide.
It has also been in touch with the US Food and Drug Administration and is currently finalizing its submission documents for Emergency Use Authorization for the test, with Fangareggi noting the timing of the tests' availability will depend on how quickly the FDA moves through the authorization process.
Italy is an epicenter of the SARS-CoV-2 pandemic, but the outbreak hasn't stopped production for Sentinel. Fangareggi said there have been no supply chain issues despite the country's lockdown. "Italy is experiencing a difficult situation," he added in an email. "Nevertheless, also in this hard time, we are fulfilling our partners' requests in all our businesses" and "guaranteeing the safety and the protection of our employees."
The company's three main focus areas are clinical chemistry, molecular biology, and fecal immunochemical testing. Clinical chemistry and FIT are Sentinel's historical business lines and clinical chemistry is "the most important and the biggest one," Fangareggi said. The molecular diagnostics line started more recently, launching in 2008.
In the clinical chemistry area, Sentinel has about 60 products that are cleared by the FDA, including its Albumin BCP assay to measure albumin in human serum or plasma, which was cleared at the end of last year.
Its clinical chemistry assays run on instruments from a variety of vendors, including Abbott, since Sentinel mostly manages diagnostic tests. According to Gramegna, the company has approximately 30 different automatic analyzers to verify and certify its assays.
Sentinel Diagnostics doesn't distribute its assays directly to the end user, Gramegna noted, but instead partners with major distributors in each country – in the US, those companies include Abbott and Beckman Coulter.
Sentinel is the legal manufacturer of the assays and deals with any complaints or issues with the tests, but they are marketed as Abbott or Beckman Coulter products.
The company sometimes works with its distributors to develop tests, although Gramegna said most of its R&D projects start internally. He noted Sentinel can begin assay development on the basis of an internal decision or in collaboration with another company on a commission basis. Fangareggi noted that the company's expertise at lyophilizing molecular tests makes it unique, since many firms have liquid formats of their assays and are looking for freeze-dried versions.
R&D is a significant investment for the company, Fangareggi noted. Out of the €50 million ($53.5 million) in revenue brought in last year, the company invested €3.5 million back into R&D and new instruments for production, he said.
Sentinel's patented proprietary STAT-NAT (Stabilized Amplification Technology – Nucleic Acid Testing) technology is used for all of the company's molecular diagnostic tests, Gramegna said. The methods contains a protective compound to stabilize the activity of enzyme, which allows for room-temperature storage and shipment. It also allows for manufacturing the reagents' master mix for amplification in a single vial, so both DNA and RNA can be developed in one ready-to-use container.
Other tests available on the STAT-NAT line include an upcoming multiplex pharmacogenetic test, an RT-qPCR mix for herpes simplex virus (types 1 and 2), a polyomavirus detection test, and multiplex malaria screening and typing assays.
What makes Sentinel's diagnostic tests special, said Fangareggi, is that their products are stable for longer than others on the market – up to two years at room temperature.
The company also has other technology in development, including its SENTiNAT 200 PCR platform, a fully automated solution for PCR-based diagnostics that is expected to launch in the first quarter of 2021. It will include a robotic workstation to automate sample preparation and two thermal cyclers to manage the workflow. Sentinel's COVID-19 assay will be available on the instrument, as will the company's other molecular assays. A molecular respiratory panel in also in the company's pipeline, which will include mycobacterium screening and resistances, Fangareggi said.
The final component of Sentinel's business is its fecal immunochemical testing product line, which includes the FOB Gold, a sample collection device for fecal occult blood testing, and the SentiFit 270, a high-speed system for FIT testing. The SentiFit 270 can run up to 270 tests per hour, while the company's other FIT instrument, the SentiFOB, can run up to 100 tests an hour. Sentinel also has its CALiaGold quantitative immunoassay, to measure calprotectin in stool samples. The CALiaGold test is the first in an upcoming panel test that will combine multiple tests for complete characterization of stool specimens. The company is the supplier of national and regional colorectal screening programs in Europe, including in the Netherlands, Spain, and Belgium.