07.26.18
$12.1 Billion
KEY EXECUTIVES:
Vincent A. Forlenza, Chairman and CEO
Thomas E. Polen, President
Alexandre Conroy, Worldwide President, Medication and Procedural Solutions
Nabil Shabshab, Worldwide President, Diabetes Care and Digital Health
Christopher R. Reidy, Exec. VP, CFO, and Chief Administrative Officer
Patrick Kaltenbach, Exec. VP and President, Life Sciences Segment
Alberto Mas, Exec. VP and President, Medical Segment
William A. Tozzi, Exec. VP and President, Interventional Segment
NO. OF EMPLOYEES: 41,933
GLOBAL HEADQUARTERS: Franklin Lakes, N.J.
Vincent Forlenza is obviously no stranger to blockbuster deals. Two years after claiming CareFusion for $12 billion, he decided it wasn’t quite enough to keep up with the string of megamergers rocking the medical device industry to counteract widespread slowdown in revenue growth as well as healthcare provider consolidation.
After all, he had elite (i.e., Top 30) companies to keep pace with. The medical device industry’s collective annual spit-takes began in April 2014, when orthopedic giants Zimmer and Biomet merged for a cool $13.4 billion. After medtech professionals had replaced their coffee-ruined computers, two months later, Medtronic made the announcement about a theretofore unheard of $43 billion-sized deal for Covidien. (Hopefully they had the wherewithal to turn their heads away from the screen this time.) A year later, Abbott made headlines for its $25 billion purchase of St. Jude Medical.
Last year, megamerger fervor came right into MPO’s backyard. Franklin Lakes, N.J.-based global medical technology firm Becton, Dickinson and Company (BD) proclaimed its intent to purchase Murray Hill, N.J. based C.R. Bard (Bard)—conveniently located about an hour’s drive apart without traffic—for $24 billion last April.
BD’s wide-ranging lineup includes products in diagnostics, diabetes care, injection, anesthesia, pharmacy, and laboratory automation. By bringing Bard into the fold, BD inherited a slew of oncology, vascular, urology, and specialty surgical offerings to tap into the market for devices used to treat vascular conditions and cancer.
ANALYST INSIGHTS: The BD and Bard integration is still underway, without a clear decision on the success of the merger. The slow process of integration is taking its time, as both companies were behemoths to begin with, and the critical synergies they were working towards have yet to be realized. Everyone is waiting to see which businesses and business units will start to operate separately or be sold off.
Vascular products were a particularly fruitful area for Bard. In 2016, they made up nearly a third of the company’s $3.7 billion in sales. BD has said that bringing Bard’s vascular products, particularly peripherally inserted central catheters, midlines, and drug delivery ports, together with its devices to prepare, dispense, and administer drugs, will help the combined company address a wider range of medication management needs. The companies together will also offer a more comprehensive lineup of products addressing surgical site infections and catheter-related bloodstream infections.
Bard’s portfolio will also empower BD to spread its treatment of disease states beyond diabetes. The combined company will be able to offer therapeutic products for diabetes, peripheral vascular disease, urology, hernia, and cancer.
“We will be able to partner (with providers) on fundamental treatment processes in a way that no one else can,” Forlenza told Reuters.
Both companies had historically garnered most of their sales from U.S. customers, but BD noted that Bard’s head start in international markets made it quite an attractive target. Bard currently has about 500 products already registered for sale overseas. Bard’s strong presence in vascular access and surgery will help to drive sales of the recently acquired CareFusion portfolio, and according to BD, Bard is among the fastest growing medical technology companies present in emerging markets.
“The combined company will have a large and growing presence in emerging markets, including $1 billion in annual revenue in China,” BD said upon the acquisition’s announcement.
Together, the companies have about $16 billion in revenue and is projected to enjoy annual revenue growth of 5 to 6 percent from this year to 2020, with earnings growth in the “mid-teens,” according to an investor presentation.
With the addition of Bard, BD created a third segment to join its Medical and Life Sciences businesses—BD Interventional. Timothy Ring, the previous chairman and CEO of Bard, joined BD’s Board of Directors when the transaction closed, along with an additional, unnamed Bard director. Tom Polen, previously executive vice president and president of BD’s Medical segment, was appointed president of BD the same day as the transaction. Polen joined BD in 1999, and will oversee all three businesses.
“This is an exciting time for BD,” he said in a company statement. “I am honored to serve in this new role as we continue our transformation into a medical technology leader focused on delivering solutions that advance the discovery, diagnostics, and delivery of healthcare globally and helping healthcare providers worldwide to improve both the process of care and the treatment of disease.”
ANALYST INSIGHTS: With the acquisition of Bard in its rearview mirror, BD is moving forward to strengthen its core portfolios in both Life Sciences and Medical Devices. It’ll be interesting to watch their next investments and which way they see their future unfolding.
Under the deal, BD also said it expected to cut $300 million in annual costs by fiscal 2020. Naturally, some were worried about job cuts being a part of the cost-cutting process. Thankfully, BD spokesman Troy Kirkpatrick mollified those wary of getting the axe.
“There isn’t overlap in what we do and what Bard does,” he told USA Today. “So we are confident that the transaction will create career opportunities for their talented employees as part of a global industry leader.”
Let’s hope BD sticks to that plan.
The BD-Bard transaction closed three days before the end of 2017. Because BD’s fiscal year ends Sept. 30, Bard is not yet included in the company’s revenue. As such, even though BD stands poised to advance a few spaces forward in next year’s Top 30 report, the $12.1 billion of sales achieved in fiscal 2017 without Bard’s help actually represented a 3 percent loss from the year prior. The slight drop reflected the approximately 7 percent revenue decline due to BD’s shedding of its Vyaire Medical Respiratory Solutions business to private equity firm Apax Partners.
BD’s Medical Segment—comprised of medication and procedural solutions, medication management solutions, diabetes care, and pharmaceutical systems—fell 6 percent in 2017 revenue to reach $8.1 billion as a result of the Respiratory Solutions franchise divestiture. Apart from that, all remaining product categories posted increases last year. Medication and Procedural Solutions sales rose a slight 2.5 percent to $3.5 billion, driven by boosted proceeds from infusion disposables products, particularly in the international markets. Medication Management Solutions experienced a 4.4 percent hike with $2.3 billion in revenue. Pharmaceutical Systems grew 4.8 percent to $1.3 billion thanks to heightened self-injection systems sales. Diabetes Care expanded its revenue by 3.3 percent to post $1.1 billion, primarily as a result of improved pen needle sales in both the United States and emerging markets.
In a move that was overshadowed by the blockbuster Bard buy, BD closed the book on its purchase of Israeli infusion pump systems manufacturer Caesarea Medical Electronics (CME) last April. BD had previously gained a 40 percent ownership interest in CME upon acquiring CareFusion, and obtained the remaining 60 percent stake in the deal.
In November 2016, BD launched the U-500 Insulin Syringe, the first insulin syringe for diabetics taking Eli Lilly & Company’s Humulin U-500 insulin. It features a 6 mm x 31-gauge needle, the shortest of its kind available at the time of launch. The short needle minimizes risk of intramuscular injection and delivers the insulin into subcutaneous tissue. It also features clearly marked dosage labeling to prevent confusion and incorrect dosing.
The NeoPak 2.25 mL prefillable glass syringe hit the U.S., European, and Japanese markets a month later. It is specially designed for biopharmaceutical manufacturers making high-value, sensitive biologic drugs requiring higher quality levels and performance to treat chronic diseases like rheumatoid arthritis, psoriasis, lupus, and severe asthma. Neopak 2.25 mL was also designed to diminish unwelcome interactions, for example drug degradation or aggregation, between the primary container and drug.
Last January during the 53rd Annual Society of Thoracic Surgeons (STS) Meeting, the PleurX catheter system earned FDA 510(k) clearance to be used in specific non-malignant pleural effusions etiologies, including congestive heart failure. Initially approved in 1997 for managing malignant and recurrent pleural effusions, the new indication expanded the system to patients suffering from congestive heart failure and cardiogenic effusions.
“The system helps patients take control of their therapy by enabling them to manage fluid from pleural effusions outside of the hospital,” said Jim Leitl, BD’s worldwide vice president and general manager for Infection Prevention, V. Mueller, and Interventional Specialties. “Patients now have the option to potentially avoid the mental and physical toll of undergoing an additional hospital procedure.”
BD’s line of Snowden-Pencer 3.0 mm laparoscopic ergonomic take-apart instruments gained FDA clearance for laparoscopic surgery last June. The new instruments used in micro-laparoscopic surgery function like their 5.0 mm counterparts, with jaw lengths that mirror standard laparoscopic instruments. That way, surgeons can use a less invasive approach without compromising functionality. The new line’s launch gave BD one of the most customizable portfolios of 3.0 mm micro-laparoscopic instruments available—26 different jaw patterns, two different lengths (24 cm, 36 cm) and six take-apart handles, provide 312 combinations to target procedures in multiple specialties.
Last September, BD launched the Ultra-Fine micro pen needle 6 mm x 32G for leading pen injection devices. The shorter needle rounded out BD’s Ultra-Fine pen needle offering, which now includes 4mm x 32G, 5mm x 31G, 6mm x 32G, 8mm x 31G and 12.7mm x 29G. The needle helps prevent diabetic patients from injecting insulin into the muscle, and also ensures a comfortable injection experience due to micro-bonded needle lubrication for less friction.
BD’s Life Sciences business—which contains preanalytical systems, diagnostic systems, and biosciences offerings—rose a modest 4.2 percent to achieve $4 billion in 2017 revenue. Sales of preanalytical systems rose 4.4 percent to $1.5 billion. Diagnostics systems earned $1.4 billion, growing 5.9 percent from the year prior. Biosciences revenues posted $1.1 billion of sales, expanding 1.8 percent. Global sales growth was stimulated by boosted income from safety-engineered products, increased earnings from microbiology and molecular platforms (particularly in emerging markets), and augmented biosciences unit proceeds in developed markets.
On Halloween 2016, the MAX Vaginal Panel, a first-of-its-kind molecular test to detect the most common causes for vaginitis, won FDA market authorization. The assay is the first multiplex, real-time PCR test authorized to diagnose both vaginitis and vaginosis in women exhibiting vaginal infection symptoms. With the MAX Vaginal Panel’s introduction, labs and clinicians can use a single test to screen patients for microorganisms responsible for Bacterial Vaginosis, Trichomaniasis, and Vulvovaginal Candidiasis (yeast infection). The market authorization was granted under the de novo pathway.
Last January, BD launched Precise whole transcriptome analysis (WTA) kits to identify and quantify genetic information in individual cells for genomics-based research. WTA is usually used to determine if an under- or over-expression of certain genes are indicative of a specific set of physical characteristics, or phenotype. The kits include specialized agents to extract RNA molecules from individual cells, then “tag” each with a unique molecular signature to count individual instances of each molecule. Quantifying RNS cells comprising genes helps determine what makes healthy cells different from diseased cells.
The FACSVia flow cytometer system achieved FDA clearance last April. With a compact design that fits on a benchtop or within a hood, the system contains a leucocount reagent assay used in residual white blood cell enumeration. The BACSVia system provides blood banks and clinical labs with a cell analysis solution to help determine and quantify the presence of residual white blood cells in their blood products.
The company earned FDA 510(k) clearance for the MAX extended enteric bacterial panel last June. The molecular test targets infectious diarrhea by detecting harmful intestinal bacteria. It is the latest offering in the MAX enteric assays portfolio, which help to detect and diagnose acute gastroenteritis. It joins the MAX enteric bacterial and parasite panels to allow individualized testing based on the patient’s symptoms and health history.
A month later, the FACSLyric flow cytometer system won FDA clearance for use with the firm’s Multitest assays for immunological assessment of individuals and patients having or suspected of having immune deficiency. FACSLyric combines a benchtop-sized instrument with software, reagents, and services in order to ensure accurate, reliable, and repeatable results. FACSLyric supports the Multitest 4-Color assays and the Multitest 6-Color TBNK assay, whose metrics can be used together to evaluate the immunology of those who may have immune deficiency.
Four days before the close of BD’s fiscal year, it launched the Phoenix CPO (carbapenamase-producing organisms) detect test in Europe. CPOs, specifically carbapenem-resistant Enterobacteriaceae (CRE), are a prominent public health threat due to their resistance to nearly all available antibiotics, and are included on the World Health Organization’s priority pathogen list as critical threats. According to a 2015 study in the Journal of Antimicrobial Chemotherapy, rates of mortality associated with certain CPO infections vary widely from 22 to 72 percent. The Phoenix CPO detect test, included on Phoenix gram-negative panels, identifies CPOs and provides the Ambler classification of the enzyme produced in under 36 hours. That way, hospitals and labs can categorize antimicrobial resistance and rapidly implement infection control measures and select the appropriate antibiotics.
Last August, the FDA began an investigation that sought to determine a link between BD blood collection tubes and faulty results for Magellan Diagnostics’ LeadCare lead testing systems. Last May, Magellan had previously received an FDA warning for inaccurate results reported on blood samples. Prior to that, Magellan had said inaccurate results may be linked to a change in the composition of the tops of certain BD blood collection tubes. At the time, the FDA said they found several violations at BD’s New Jersey facility, but “have not determined that the BD tubes or any other brand of tube is linked to the cause of the inaccurate lead test results,” and “…are continuing to aggressively investigate the matter.”
The investigation ultimately led to a January 2018 warning letter citing that the company marketed certain BD Vacutainer blood collection tubes with significant changes to the rubber stoppers without required FDA clearance or approval, and failed to submit medical device reports to the FDA within the required timeframe. The inspection also revealed BD did not evaluate or investigate the previous complaints regarding Magellan’s lead testing systems. The company recalled the tubes in question this past March. The issue was discovered to be a chemical in the rubber tube stopper that interferes with the accuracy of Anodic Stripping Voltammetry testing methodology, which is used in Magellan’s LeadCare test.
KEY EXECUTIVES:
Vincent A. Forlenza, Chairman and CEO
Thomas E. Polen, President
Alexandre Conroy, Worldwide President, Medication and Procedural Solutions
Nabil Shabshab, Worldwide President, Diabetes Care and Digital Health
Christopher R. Reidy, Exec. VP, CFO, and Chief Administrative Officer
Patrick Kaltenbach, Exec. VP and President, Life Sciences Segment
Alberto Mas, Exec. VP and President, Medical Segment
William A. Tozzi, Exec. VP and President, Interventional Segment
NO. OF EMPLOYEES: 41,933
GLOBAL HEADQUARTERS: Franklin Lakes, N.J.
Vincent Forlenza is obviously no stranger to blockbuster deals. Two years after claiming CareFusion for $12 billion, he decided it wasn’t quite enough to keep up with the string of megamergers rocking the medical device industry to counteract widespread slowdown in revenue growth as well as healthcare provider consolidation.
After all, he had elite (i.e., Top 30) companies to keep pace with. The medical device industry’s collective annual spit-takes began in April 2014, when orthopedic giants Zimmer and Biomet merged for a cool $13.4 billion. After medtech professionals had replaced their coffee-ruined computers, two months later, Medtronic made the announcement about a theretofore unheard of $43 billion-sized deal for Covidien. (Hopefully they had the wherewithal to turn their heads away from the screen this time.) A year later, Abbott made headlines for its $25 billion purchase of St. Jude Medical.
Last year, megamerger fervor came right into MPO’s backyard. Franklin Lakes, N.J.-based global medical technology firm Becton, Dickinson and Company (BD) proclaimed its intent to purchase Murray Hill, N.J. based C.R. Bard (Bard)—conveniently located about an hour’s drive apart without traffic—for $24 billion last April.
BD’s wide-ranging lineup includes products in diagnostics, diabetes care, injection, anesthesia, pharmacy, and laboratory automation. By bringing Bard into the fold, BD inherited a slew of oncology, vascular, urology, and specialty surgical offerings to tap into the market for devices used to treat vascular conditions and cancer.
ANALYST INSIGHTS: The BD and Bard integration is still underway, without a clear decision on the success of the merger. The slow process of integration is taking its time, as both companies were behemoths to begin with, and the critical synergies they were working towards have yet to be realized. Everyone is waiting to see which businesses and business units will start to operate separately or be sold off.
—Marissa K. Fayer, CEO and Founder, Health Equity for Women and HERHealthEQ
Vascular products were a particularly fruitful area for Bard. In 2016, they made up nearly a third of the company’s $3.7 billion in sales. BD has said that bringing Bard’s vascular products, particularly peripherally inserted central catheters, midlines, and drug delivery ports, together with its devices to prepare, dispense, and administer drugs, will help the combined company address a wider range of medication management needs. The companies together will also offer a more comprehensive lineup of products addressing surgical site infections and catheter-related bloodstream infections.
Bard’s portfolio will also empower BD to spread its treatment of disease states beyond diabetes. The combined company will be able to offer therapeutic products for diabetes, peripheral vascular disease, urology, hernia, and cancer.
“We will be able to partner (with providers) on fundamental treatment processes in a way that no one else can,” Forlenza told Reuters.
Both companies had historically garnered most of their sales from U.S. customers, but BD noted that Bard’s head start in international markets made it quite an attractive target. Bard currently has about 500 products already registered for sale overseas. Bard’s strong presence in vascular access and surgery will help to drive sales of the recently acquired CareFusion portfolio, and according to BD, Bard is among the fastest growing medical technology companies present in emerging markets.
“The combined company will have a large and growing presence in emerging markets, including $1 billion in annual revenue in China,” BD said upon the acquisition’s announcement.
Together, the companies have about $16 billion in revenue and is projected to enjoy annual revenue growth of 5 to 6 percent from this year to 2020, with earnings growth in the “mid-teens,” according to an investor presentation.
With the addition of Bard, BD created a third segment to join its Medical and Life Sciences businesses—BD Interventional. Timothy Ring, the previous chairman and CEO of Bard, joined BD’s Board of Directors when the transaction closed, along with an additional, unnamed Bard director. Tom Polen, previously executive vice president and president of BD’s Medical segment, was appointed president of BD the same day as the transaction. Polen joined BD in 1999, and will oversee all three businesses.
“This is an exciting time for BD,” he said in a company statement. “I am honored to serve in this new role as we continue our transformation into a medical technology leader focused on delivering solutions that advance the discovery, diagnostics, and delivery of healthcare globally and helping healthcare providers worldwide to improve both the process of care and the treatment of disease.”
ANALYST INSIGHTS: With the acquisition of Bard in its rearview mirror, BD is moving forward to strengthen its core portfolios in both Life Sciences and Medical Devices. It’ll be interesting to watch their next investments and which way they see their future unfolding.
—Dave Sheppard, Co-Founder and Principal, MedWorld Advisors
Under the deal, BD also said it expected to cut $300 million in annual costs by fiscal 2020. Naturally, some were worried about job cuts being a part of the cost-cutting process. Thankfully, BD spokesman Troy Kirkpatrick mollified those wary of getting the axe.
“There isn’t overlap in what we do and what Bard does,” he told USA Today. “So we are confident that the transaction will create career opportunities for their talented employees as part of a global industry leader.”
Let’s hope BD sticks to that plan.
The BD-Bard transaction closed three days before the end of 2017. Because BD’s fiscal year ends Sept. 30, Bard is not yet included in the company’s revenue. As such, even though BD stands poised to advance a few spaces forward in next year’s Top 30 report, the $12.1 billion of sales achieved in fiscal 2017 without Bard’s help actually represented a 3 percent loss from the year prior. The slight drop reflected the approximately 7 percent revenue decline due to BD’s shedding of its Vyaire Medical Respiratory Solutions business to private equity firm Apax Partners.
BD’s Medical Segment—comprised of medication and procedural solutions, medication management solutions, diabetes care, and pharmaceutical systems—fell 6 percent in 2017 revenue to reach $8.1 billion as a result of the Respiratory Solutions franchise divestiture. Apart from that, all remaining product categories posted increases last year. Medication and Procedural Solutions sales rose a slight 2.5 percent to $3.5 billion, driven by boosted proceeds from infusion disposables products, particularly in the international markets. Medication Management Solutions experienced a 4.4 percent hike with $2.3 billion in revenue. Pharmaceutical Systems grew 4.8 percent to $1.3 billion thanks to heightened self-injection systems sales. Diabetes Care expanded its revenue by 3.3 percent to post $1.1 billion, primarily as a result of improved pen needle sales in both the United States and emerging markets.
In a move that was overshadowed by the blockbuster Bard buy, BD closed the book on its purchase of Israeli infusion pump systems manufacturer Caesarea Medical Electronics (CME) last April. BD had previously gained a 40 percent ownership interest in CME upon acquiring CareFusion, and obtained the remaining 60 percent stake in the deal.
In November 2016, BD launched the U-500 Insulin Syringe, the first insulin syringe for diabetics taking Eli Lilly & Company’s Humulin U-500 insulin. It features a 6 mm x 31-gauge needle, the shortest of its kind available at the time of launch. The short needle minimizes risk of intramuscular injection and delivers the insulin into subcutaneous tissue. It also features clearly marked dosage labeling to prevent confusion and incorrect dosing.
The NeoPak 2.25 mL prefillable glass syringe hit the U.S., European, and Japanese markets a month later. It is specially designed for biopharmaceutical manufacturers making high-value, sensitive biologic drugs requiring higher quality levels and performance to treat chronic diseases like rheumatoid arthritis, psoriasis, lupus, and severe asthma. Neopak 2.25 mL was also designed to diminish unwelcome interactions, for example drug degradation or aggregation, between the primary container and drug.
Last January during the 53rd Annual Society of Thoracic Surgeons (STS) Meeting, the PleurX catheter system earned FDA 510(k) clearance to be used in specific non-malignant pleural effusions etiologies, including congestive heart failure. Initially approved in 1997 for managing malignant and recurrent pleural effusions, the new indication expanded the system to patients suffering from congestive heart failure and cardiogenic effusions.
“The system helps patients take control of their therapy by enabling them to manage fluid from pleural effusions outside of the hospital,” said Jim Leitl, BD’s worldwide vice president and general manager for Infection Prevention, V. Mueller, and Interventional Specialties. “Patients now have the option to potentially avoid the mental and physical toll of undergoing an additional hospital procedure.”
BD’s line of Snowden-Pencer 3.0 mm laparoscopic ergonomic take-apart instruments gained FDA clearance for laparoscopic surgery last June. The new instruments used in micro-laparoscopic surgery function like their 5.0 mm counterparts, with jaw lengths that mirror standard laparoscopic instruments. That way, surgeons can use a less invasive approach without compromising functionality. The new line’s launch gave BD one of the most customizable portfolios of 3.0 mm micro-laparoscopic instruments available—26 different jaw patterns, two different lengths (24 cm, 36 cm) and six take-apart handles, provide 312 combinations to target procedures in multiple specialties.
Last September, BD launched the Ultra-Fine micro pen needle 6 mm x 32G for leading pen injection devices. The shorter needle rounded out BD’s Ultra-Fine pen needle offering, which now includes 4mm x 32G, 5mm x 31G, 6mm x 32G, 8mm x 31G and 12.7mm x 29G. The needle helps prevent diabetic patients from injecting insulin into the muscle, and also ensures a comfortable injection experience due to micro-bonded needle lubrication for less friction.
BD’s Life Sciences business—which contains preanalytical systems, diagnostic systems, and biosciences offerings—rose a modest 4.2 percent to achieve $4 billion in 2017 revenue. Sales of preanalytical systems rose 4.4 percent to $1.5 billion. Diagnostics systems earned $1.4 billion, growing 5.9 percent from the year prior. Biosciences revenues posted $1.1 billion of sales, expanding 1.8 percent. Global sales growth was stimulated by boosted income from safety-engineered products, increased earnings from microbiology and molecular platforms (particularly in emerging markets), and augmented biosciences unit proceeds in developed markets.
On Halloween 2016, the MAX Vaginal Panel, a first-of-its-kind molecular test to detect the most common causes for vaginitis, won FDA market authorization. The assay is the first multiplex, real-time PCR test authorized to diagnose both vaginitis and vaginosis in women exhibiting vaginal infection symptoms. With the MAX Vaginal Panel’s introduction, labs and clinicians can use a single test to screen patients for microorganisms responsible for Bacterial Vaginosis, Trichomaniasis, and Vulvovaginal Candidiasis (yeast infection). The market authorization was granted under the de novo pathway.
Last January, BD launched Precise whole transcriptome analysis (WTA) kits to identify and quantify genetic information in individual cells for genomics-based research. WTA is usually used to determine if an under- or over-expression of certain genes are indicative of a specific set of physical characteristics, or phenotype. The kits include specialized agents to extract RNA molecules from individual cells, then “tag” each with a unique molecular signature to count individual instances of each molecule. Quantifying RNS cells comprising genes helps determine what makes healthy cells different from diseased cells.
The FACSVia flow cytometer system achieved FDA clearance last April. With a compact design that fits on a benchtop or within a hood, the system contains a leucocount reagent assay used in residual white blood cell enumeration. The BACSVia system provides blood banks and clinical labs with a cell analysis solution to help determine and quantify the presence of residual white blood cells in their blood products.
The company earned FDA 510(k) clearance for the MAX extended enteric bacterial panel last June. The molecular test targets infectious diarrhea by detecting harmful intestinal bacteria. It is the latest offering in the MAX enteric assays portfolio, which help to detect and diagnose acute gastroenteritis. It joins the MAX enteric bacterial and parasite panels to allow individualized testing based on the patient’s symptoms and health history.
A month later, the FACSLyric flow cytometer system won FDA clearance for use with the firm’s Multitest assays for immunological assessment of individuals and patients having or suspected of having immune deficiency. FACSLyric combines a benchtop-sized instrument with software, reagents, and services in order to ensure accurate, reliable, and repeatable results. FACSLyric supports the Multitest 4-Color assays and the Multitest 6-Color TBNK assay, whose metrics can be used together to evaluate the immunology of those who may have immune deficiency.
Four days before the close of BD’s fiscal year, it launched the Phoenix CPO (carbapenamase-producing organisms) detect test in Europe. CPOs, specifically carbapenem-resistant Enterobacteriaceae (CRE), are a prominent public health threat due to their resistance to nearly all available antibiotics, and are included on the World Health Organization’s priority pathogen list as critical threats. According to a 2015 study in the Journal of Antimicrobial Chemotherapy, rates of mortality associated with certain CPO infections vary widely from 22 to 72 percent. The Phoenix CPO detect test, included on Phoenix gram-negative panels, identifies CPOs and provides the Ambler classification of the enzyme produced in under 36 hours. That way, hospitals and labs can categorize antimicrobial resistance and rapidly implement infection control measures and select the appropriate antibiotics.
Last August, the FDA began an investigation that sought to determine a link between BD blood collection tubes and faulty results for Magellan Diagnostics’ LeadCare lead testing systems. Last May, Magellan had previously received an FDA warning for inaccurate results reported on blood samples. Prior to that, Magellan had said inaccurate results may be linked to a change in the composition of the tops of certain BD blood collection tubes. At the time, the FDA said they found several violations at BD’s New Jersey facility, but “have not determined that the BD tubes or any other brand of tube is linked to the cause of the inaccurate lead test results,” and “…are continuing to aggressively investigate the matter.”
The investigation ultimately led to a January 2018 warning letter citing that the company marketed certain BD Vacutainer blood collection tubes with significant changes to the rubber stoppers without required FDA clearance or approval, and failed to submit medical device reports to the FDA within the required timeframe. The inspection also revealed BD did not evaluate or investigate the previous complaints regarding Magellan’s lead testing systems. The company recalled the tubes in question this past March. The issue was discovered to be a chemical in the rubber tube stopper that interferes with the accuracy of Anodic Stripping Voltammetry testing methodology, which is used in Magellan’s LeadCare test.
