Becton, Dickinson and Co. (BD) has received a green light for a premarket approval supplement from the U.S. FDA for an expanded version of its BD Onclarity HPV assay. It includes the expansion for genotype reporting beyond human papilloma virus (HPV) genotypes 16, 18, and 45.
Several companies have reported quarterly results over the past couple of days, and those offering testing for COVID-19 have seen impressive numbers. Standing out was San Diego-based Quidel Corp., whose numbers caught the attention of William Blair’s Brian Weinstein. Indeed, its $174.7 million in revenue far exceeded his organization’s estimate of $160 million, driven by influenza.
The COVID-19 pandemic has shaken the world – and the face of diagnostics. In a matter of weeks, a host of companies has worked to develop tests to find those patients who currently have the disease, as well as those who have developed antibodies.
The U.S. Patent Trial and Appeal Board (PTAB) determined it would not take an inter partes review petitioned by Advanced Bionics Inc., in a patent dispute with Med-El Elektromedizinische. The precedential PTAB decision notes that it had invoked a two-step process for declining to take the petition as seen in a patent dispute involving Becton Dickinson and Co., and affirming that this will be the standard for addressing prior art in such appeals going forward.
Making routine diagnostic blood tests less invasive, easier, cheaper and more accessible is a worthy goal. But achieving it has eluded many, including former unicorn startup Theranos that boasted it had achieved precisely that but then was later exposed as a fraud. Established med-tech player Becton, Dickinson and Co. (BD) and Babson Diagnostics Inc. have established a long-term strategic partnership to bring laboratory quality, small-volume blood collection into the retail pharmacy setting.
Becton, Dickinson and Co. (BD) (NYSE:BDX) reported revenue of $4.23 billion for the first quarter of fiscal year 2020, ended Dec. 31, up 1.6% from the same period a year ago. Revenue grew 2.5% on a currency-neutral basis. However, an unexpected regulatory hurdle for its Alaris infusion pumps caused the Franklin Lakes, N.J.-based company to lower its 2020 revenue and earnings guidance. Despite the shadow cast by the Alaris news, BD beat Street expectations for the quarter – clocking in at $4.23 billion vs. $4.18 billion.
PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.