Skip to main content
Premium Trial:

Request an Annual Quote

BD Diagnostics Unit Reports Q4, Full-Year Growth; Delays in MDx Product Pipeline

Premium

Becton Dickinson reported this week that its BD Diagnostics business logged a 6 percent increase in fiscal fourth quarter revenues and a 5 percent increase in fiscal 2013 full-year revenues, with Q4 driven in part by sales of the company's BD Max molecular testing system.

In addition, executives from the company disclosed that the commercialization timelines for several of its molecular diagnostic tests currently under development, as well as its forthcoming next-generation Viper molecular testing platform, have been delayed by at least a quarter.

Separately this week, BD said that it has garnered CE IVD marking for the Totalys MultiProcessor, an instrument designed to automate sample prep for both cytology-based and molecular cervical cancer testing.

For the three months ended Sept. 30, BD Diagnostics' revenues increased to $680 million from $645 million. This contributed to an overall 7 percent spike in fiscal fourth quarter revenues at the company, which also includes the BD Medical and BD Biosciences business segments. For fiscal 2013, BD Diagnostics' revenues increased to $2.65 billion from $2.54 billion, while total company revenues were up 4 percent to $8.05 billion from $7.71 billion.

During a conference call recapping the company's earnings, Christopher Reidy, CFO and executive vice president of administration, noted that Q4 growth in the Diagnostics segment was driven by sales of safety-engineered products from the Preanalytical Systems division, Kiestra lab automation products, and "continued ramp-up of BD Max in Diagnostic Systems." BD Max is the company's multiplex real-time PCR system that has been on the market for a few years and enables users to run pre-designed commercial assays or develop their own tests in house.

During the call, BD executives also updated the company's diagnostics pipeline, including its molecular diagnostics products in development.

In January, former BD Diagnostics President Tom Polen — currently group president of BD's medical surgical systems and preanalytical and pharmaceutical systems — provided PCR Insider with a roadmap of the company's molecular diagnostics strategy (PCR Insider 1/3/2013).

That roadmap included gearing up to launch Viper LT, the next-generation version of its Viper XTR platform, which currently runs assays based on isothermal strand displacement amplification and is designed more for high-throughput women's health screening assays.

Viper LT features both PCR and SDA capabilities and its flagship assay will be a human papillomavirus screening and typing test that BD believes will contend with established molecular assays from the likes of Qiagen, Roche, Abbott, and Hologic's Gen-Probe. Eventually, BD hopes to migrate all existing Viper XTR assays — which include tests for Trichomonas, Chlamydia trachomatis and Neisseria gonorrhea (GC/CT), and herpes simplex viruses 1 and 2 — to the Viper LT.

Polen indicated at the time that Viper LT and the associated HPV genotyping test were set to launch outside the US by the end of this calendar year, with the company having already initiated clinical trials ex-US.

During the call this week, Polen re-confirmed that the test — now called Onclarity HPV — "remains on track to launch ex-US this quarter," meaning BD's FY2014 first quarter. The company has not shared the planned US launch date, he noted.

BD is also developing a follow-on GC/CT assay for Viper LT, and previously indicated that the test would launch in the EU this quarter and was on target to garner US Food and Drug Administration clearance by Q2 FY2014 (the first quarter of calendar year 2014). The company noted this week that this assay has been delayed and is now likely to launch ex-US in Q2 of FY2014 — a one-quarter delay — and receive FDA clearance in Q4 FY2014 — a two-quarter delay.

Furthermore, BD has been growing its menu of assays — developed both internally and with partners — for BD Max. The company launched a BD Max Staph SR assay in the EU last quarter, and plans to launch this test in the US in Q2 of FY2014. However, the company has delayed the US launch of a BD Max enteric bacteria test one quarter to Q3 FY 2014; and the general commercial launch of a GC/CT and GC/CT/Trich test more than two quarters to FY 2015.

Finally, the company noted that during Q4 FY2013 it launched its Totalys automation product in the EU, but that the US product launch has been delayed two quarters to the second quarter of FY2015. Totalys is designed to automate sample processing from the company's SurePath sample vials and manage chain of custody across its suite of molecular and cytology systems, and is intended to complement the Viper LT and HPV genotyping assay.

Commenting on the various delays during this week's call, Polen said that two major factors have been contributing. "One is related to clinical trial prevalence," he said. "As we're doing more complex panels on [BD Max], of course, we end up [looking at] a large number of organisms … in each panel, and the prevalence of those vary significantly."

The other major factor, he noted, "was just further feedback from FDA related to the depth of the trials required. And that one was specific if you look at Totalys in the US. So while we did launch Totalys ex-US in Q4 and fulfilled a nice backlog of orders we had there, the US is going to take us a little longer based on feedback for additional testing that we had gotten from the FDA."

Nevertheless, BD Diagnostics is starting to see some meaningful revenue contributions from its molecular portfolio and BD Max specifically, although the company did not quantify this contribution.

"As we shared earlier this year, we expected that it was going to take until the second half of FY13 to really see [BD Max] growth starting to fully offset the declines that we had seen in GeneOhm from prior years," Polen said, referring to the company's first-generation GeneOhm real-time PCR kits for various infectious diseases. "And we are very pleased that we're seeing that positive trajectory. We're up high single digits for the quarter overall. We're seeing very positive feedback from customers. We're now approaching about 300 installations in the field and continue to focus on our menu expansion there."

For full-year FY2014, BD estimated that revenues will grow in the 4 to 5 percent range on a reported and currency-neutral basis. This contemplates a 3.5 to 4.5 percent increase in Diagnostics, a 3 to 4 percent increase in Biosciences, and a 4.5 to 5.5 percent increase in Medical.

The Scan

Fertility Fraud Found

Consumer genetic testing has uncovered cases of fertility fraud that are leading to lawsuits, according to USA Today.

Ties Between Vigorous Exercise, ALS in Genetically At-Risk People

Regular strenuous exercise could contribute to motor neuron disease development among those already at genetic risk, Sky News reports.

Test Warning

The Guardian writes that the US regulators have warned against using a rapid COVID-19 test that is a key part of mass testing in the UK.

Science Papers Examine Feedback Mechanism Affecting Xist, Continuous Health Monitoring for Precision Medicine

In Science this week: analysis of cis confinement of the X-inactive specific transcript, and more.