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BD Launches DIY Reagent Kit for LDTs on BD Max System; Continues to Scale Up MDx Offerings

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NEW YORK (GenomeWeb) — Becton Dickinson's BD Diagnostics division announced this week the launch of the Total Nucleic Acid suite, a kit of reagents to enable DNA- and RNA-based assay development on the automated BD Max platform.

In an interview this week with PCR Insider, Doug White, vice president and general manager of molecular diagnostics and women's health at BD Diagnostics, said the TNA kit will allow laboratory customers to develop their own molecular diagnostic tests.

The TNA sample prep chemistry is designed for extraction of both DNA and RNA. This functionality could be useful for panels aiming to detect both viral and bacterial targets, such as ones for comprehensive respiratory illness evaluations, "where you need RNA for viral, and DNA for bacterial targets," White said.

The TNA kit will also provide basic master mix reagents that customers can use to develop their own assays on the BD Max platform, White said.

"This makes our system pretty unique," he said. "They can do their own lab-developed test, and it's really a fully automated platform once they do the development."

For example, customers can identify targets and develop chemistries compatible with the TNA sample preparation, validate a new assay with clinical samples, and then offer a new diagnostic test in their own institution, White said.

In addition, BD will be utilizing the chemistries and capabilities of the TNA kit in its own in vitro diagnostic tests.

"Now we'll have a specific set of reagents that we can use for DNA and RNA extraction, so that will be incorporated, as we move forward, in kits that we submit for regulatory approval," White said.

BD Max is one of three platforms for molecular testing — the others are Viper XTR and Viper LT — currently marketed by Becton Dickinson. The BD Max system is targeted to acute care settings, with a menu of tests "designed to meet the needs of the hospital," White explained. It is a benchtop, random access, and fully automated platform.

The current BD Max test menu includes assays for Clostridium difficile, methicillin-resistant Staphylococcus aureus, and Group B Strep, a test to simultaneously detect MRSA and S. aureus, and an enteric bacterial panel. The company also offers tests on BD Max with partner Diagenode, including enteric viral, Flu A/B, and Bordetella pertussis assays.

BD obtained US Food and Drug Administration clearance for the enteric bacterial panel in May of this year. As previously reported in PCR Insider, the BD Max Enteric Panel is a qualitative in vitro diagnostic test that detects DNA from Campylobacter spp. (jejuni and coli), Salmonella spp., Shigella spp./enteroinvasive Escherichia coli, as well as stx 1 and stx 2 genes in stool specimens. These pathogens are responsible for up to 95 percent of bacterial gastroenteritis and account for millions of deaths annually, according to the US Centers for Disease Control and Prevention.

A BD-funded study recently published in The Journal of Clinical Microbiology showed the enteric panel was more sensitive than traditional culture methods on preserved stool samples. That study also cited previous investigations demonstrating a diagnostic yield of stool culture as low as 1.5 percent, with a cost per positive culture as high as $1,200.

And in June, a study in The European Journal of Clinical Microbiology and Infectious Diseases compared BD's enteric panel to molecular diagnostics from R-Biopharm and Fast Track Diagnostics, as well as to traditional culture methods, concluding the BD Max panel was "the fastest, easiest to use, and most flexible."

The company also continues to work on a molecular diagnostic panel for common enteric parasites.

In May, BD obtained CE marking on this assay. It is also a qualitative in vitro diagnostic test, detecting DNA from Giardia lamblia , Cryptosporidium (C. hominis and C. parvum) and Entamoeba histolytica in unpreserved or formalin-fixed stool specimens. The assay can provide results in approximately four hours, requires minimal technologist time, and could replace traditional methods such as microscopy and immunoassay, according to a statement from BD.

The new TNA kit can be used by customers to develop LDTs on the BD Max platform only, and not the Viper XTR or LT platforms.

The Viper XTR is a high-volume, high-throughput platform, while the Viper LT is designed for mid-sized clinical laboratories, White said. These are not open platforms like the BD Max, he explained, but are designed to run "screening type tests for core laboratories and reference laboratories," where centralized, routine, batch testing of samples from physicians' offices might be done.

BD launched chlamydia and gonorrhea assays on the Viper LT platform last week. The company had been marketing these assays for some time on the Viper XTR, but the assays are now also approved by the FDA for the Viper LT, and have received CE marking as well, White said.

The company also recently obtained a CE mark for an HPV kit on the Viper LT. For this test, the company is currently engaged in clinical trials in the US "in anticipation of submission to the FDA," said White.

Becton Dickinson posted a five percent increase in revenues in the third quarter of this year, with its diagnostic systems sales up nearly 2 percent to $315 million, from $310 million in Q3 2013.

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