Bio-Rad Laboratories has made its entry into the rapidly growing molecular diagnostics testing market with the launch of Amplichek II quality control, which was recently issued a de novo clearance from the U.S. Food and Drug Administration (FDA). The FDA’s de novo clearance is a classification given to devices that are considered novel, with no existing classification or predicate device on the market. Amplichek II began shipping last May and is the first in a series of infectious disease controls that Bio-Rad is introducing for the molecular diagnostic testing market. Molecular diagnostics is one of the fastest growing IVD markets, estimated to reach $9.3 billion (€8.5 billion) by 2020 with the infectious disease segment accounting for the largest share of the global market, according to a 2015 report by research firm MarketsandMarkets. The Amplichek II quality control complements the company’s already extensive range of quality controls. Amplichek II is an independent, multi-analyte quality control that monitors the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of healthcare associated infections (HAIs). HAIs can occur during the process of patient care within a healthcare facility. Millions of healthcare associated infections occur each year, leading to significantly high mortality rates. According to the Centers for Disease Control and Prevention, on any given day, about one in 25 hospital patients have at least one healthcare associated infection. Early detection of these pathogens combined with the appropriate infection control procedures can help prevent the spread of HAIs and lead to improved patient care.
The Amplichek I quality control, which was recently issued a 510(k) clearance from the U.S. Food and Drug Administration (FDA) is the second in a series of infectious disease controls that Bio-Rad is introducing for the molecular diagnostic testing this year. Amplichek I is an independent, multi-analyte quality control for the assessment of HIV-1, Hepatitis B (HBV) and Hepatitis C (HCV) nucleic acid tests that can help mitigate the limitations of manufacturer controls. Unlike some controls that are optimized for specific systems, Amplichek I can help reduce the risk associated with reporting inaccurate patient results by monitoring the performance of the complete analytical process and detecting lot-to-lot variation of assay reagents.

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The newly CE marked FilmArray Respiratory Panel 2 plus (RP2plus) tests for 22 pathogens (18 viruses and 4 bacteria) responsible for respiratory tract infections. It advances the existing FilmArray Respiratory Panel (RP) by reducing the assay time from about an hour to less than 45 minutes, improving overall sensitivity, and updating several assays. FilmArray RP2plus also includes 2 additional pathogens: Bordetella parapertussis, one of the causative agents of pertussis or whooping cough, a highly infectious bacterial disease, and Middle East Respiratory Syndrome coronavirus (MERS-CoV). According to the WHO, the recent MERS-CoV outbreak in the Republic of Korea demonstrated a great potential for widespread transmission and severe disruption both to the health system and to society. The MERS-CoV case fatality rate is approximately 36%. Bordetella parapertussis infections represent a significant cause of whooping cough which is oft en missed because of a clinical presentation largely indistinguishable from other viral infections and of lack of reliable diagnostic tests. The FilmArray RP2plus is available for use on the FilmArray 2.0 and FilmArray Torch systems and will be commercially available in the countries that recognize CE marking by mid-June 2017.
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The continued rise in prevalence rates of type 2 diabetes mellitus (T2DM) and the inadequacies of the traditional T2DM risk methods highlights the necessity for superior markers for the assessment of at-risk patients. The traditional clinical tests utilized in the risk assessment of T2DM includes fasting plasma glucose (FPG) and oral glucose intolerance test (OGTT). FPG has been proven to have poor specificity and OGTT can only be detected when the underlying disease has progressed over several years. The non-biochemical methods, body mass index (BMI), employed for the classification of overweight and obese patients does not distinguish between excess fat, muscle or bone mass. Consequently, these traditional tests are inadequate for the early risk assessment and prevention of T2DM. Adiponectin is a protein hormone secreted by adipocytes with anti-inflammatory and insulin-sensitizing properties, reducing the risk of metabolic syndrome, insulin resistance, CVD and T2DM. Adiponectin levels have been found to inversely correlate with abdominal visceral fat. One study found that using the diagnostic criteria for ADA glucose and HbA1c as a reference, adiponectin displayed a sensitivity of 88% and a specificity of 51% at a cut-off point of 7.5μg/ml (figure 1). This study concluded that adiponectin levels associate with improved glycemic control, revealing its potential as a biomarker in T2DM screening and in the assessment of prediabetic state. Adiponectin levels have also been proved to be useful in the identification of gestational diabetes mellitus (GDM) risk in early pregnancy. A nested case-control study found that women with decreased adiponectin levels measured, on average, 6 years pre-pregnancy were associated with a 5-fold increased risk of developing GDM. Not only is early risk assessment of diabetes required to improve health outcomes, but also to alleviate the burden on national health services and economies. It is evident that a superior method for assessing diabetes risk is required, enabling physicians to accurately evaluate at-risk patients. Randox Laboratories are manufacturers and distributors of an automated biochemistry adiponectin test for the early risk assessment of T2DM, CVD and metabolic syndrome.

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Roche has launched the first fully automated Zika IgG immunoassay, the Elecsys Zika IgG immunoassay for CE Mark countries, to help detect Zika virus infection. Accurate diagnosis of an infection with Zika virus is an urgent medical need, particularly for pregnant women, as an infection with Zika virus can cause impaired neurological development in babies whose mothers were infected during pregnancy. Diagnostic testing enables healthcare professionals to assess the immune status of patients, which can be of particular importance to expectant mothers, their partners and travellers, and detect evidence of a recent Zika virus infection.
This new serological assay complements a significant advancement from Roche for Zika virus screening. On 5 October 2017, the U.S. Food and Drug Administration (FDA) granted IVD status to the cobas Zika test, for use with the cobas 6800/8800 systems, for the screening of blood and plasma donations in the United States.
Zika virus serological testing could be used for accurate diagnosis of Zika virus infection when the virus’ RNA is no longer detectable in the patient’s blood sample. Due to the similarity of Zika virus to other viruses, such as Dengue virus, the Elecsys Zika IgG assay was developed as a highly specific assay to limit cross-reaction and reduce the occurrence of false positive results. This assay can also be used to later determine the seroprevalence of Zika virus in different populations and countries at risk to assess the level of immune status in a country.
Zika virus belongs to the Flaviviridae family of viruses, including Dengue, Yellow Fever, Japanese encephalitis and West Nile viruses. Zika virus is mainly spread by infected mosquitoes, though transmission may also occur through mother-to-child, sexual intercourse and infected donor blood used for transfusions. There is now evidence that Zika virus is linked to birth defects in fetuses and newborns, and neurological complications in adults. Based on a systematic review of the scientific literature, in 2016 the World Health Organization (WHO) concluded that Zika virus infection during pregnancy may cause congenital brain abnormalities, including microcephaly; and that the virus is a trigger of Guillain-Barré syndrome and subsequently declared Zika virus as a public health emergency. Today, Zika virus infection remains a significant enduring public health challenge, requiring intense action, but is no longer classified as a public health emergency.
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