In Vitro Diagnostics: Five News Stories of Note - March 2017
ROCKVILLE, Md., March 22, 2017 /PRNewswire/ -- Kalorama Information has noted five news developments in IVD that should be important to those following the industry. This month the FDA granted a CLIA waiver to Alere's point-of-care (POC) RSV test, and the POC testing market has reached $18.4 billion in sales and continues to grow. An Alere subsidiary is facing a legal battle and the acquisition by Abbott is still in limbo. Meanwhile, Beckman Coulter launched a new chemistry analyzer and researchers evaluated fetal fibronectin screening for predicting premature birth. These are some of the top in vitro diagnostics stories in March 2017. Kalorama is a market research firm with a particular focus in the in vitro diagnostics industry.
The firm recently completed a full length study in molecular diagnostics.
RSV Molecular Test Approved For Point of Care Use
Alere's molecular test for respiratory syncytial virus received a CLIA waiver on March 6, adding a third point-of-care respiratory test to the Alere i platform in the United States.
The Alere i, a benchtop instrument weighing less than seven pounds, already offers CLIA-waived tests for Strep A and Influenza A and B. The RSV test, which the FDA cleared for marketing in August 2016, will now join those tests and be available for use in physician offices, hospital emergency rooms and walk-in clinics.
"Our innovative Alere i platform now offers the key trio of respiratory assays for rapid molecular detection of RSV, Influenza A & B and Strep A in a broad range of healthcare settings," said Avi Pelossof, Alere Global President of Infectious Disease, in a statement.
The RSV test returns a result in 13 minutes or less, the company says, using Alere's proprietary Molecular In Minutes™ isothermal nucleic acid amplification technology (iNAT), which amplifies viral DNA faster than polymerase chain reaction (PCR).
Meanwhile, Cepheid received FDA clearance last month to market its own newer, faster molecular tests for respiratory infections.
The Xpert® Xpress Flu and Xpert Xpress Flu/RSV tests return results in as little as 20 minutes, according to Cepheid. These tests run twice as fast as Cepheid's previous version, the Xpert Flu/RSV XC. The new Xpress tests run on the Cepheid GeneXpert systems in proprietary test cartridges. They will also run on Cepheid's portable benchtop device, the GeneXpert Omni, which the company intends to release later this year, according to reports by GenomeWeb.
Alere Remains Competitive, Despite Legal Setbacks
Alere continues to fight in court to reinstate Medicare billing for its subsidiary Arriva Medical, a diabetes mail-order supply company. The U.S. District Court for the District of Columbia denied Arriva's motions for interim relief this month, Alere announced March 9. However, the appeal continues, because the court denied a Center Medicare and Medicaid Services (CMS) motion to dismiss Arriva's complaint. CMS revoked Arriva's Medicare billing number in October and barred the company from re-enrolling in the Medicare program for three years, accusing Arriva of submitting invoices for dead patients. Alere blamed the errors on flaws in Medicare's system, according to a report in 360Dx, and filed an administrative appeal in December to reinstate Arriva's Medicare privileges.
"We remain confident that the administrative appeal process will lead to a favorable outcome for both Arriva and the hundreds of thousands of patients who depend on us for their mail-order supplies," Alere said in its statement.
The news, however, comes on the heels of reports March 1 that Alere will file its annual report late for the second year in a row, due to possible accounting errors related to "inappropriate conduct" by a South Korean subsidiary.
It remains to be seen how these developments will impact the deal announced in early 2016 for Abbott Laboratories to acquire Alere for $5.8 billion. Alere later rejected Abbott's $50 million offer to terminate the deal and sued Abbott to complete the acquisition.
Despite these troubles, Alere remains a strong competitor in clinical diagnostics. Kalorama Information ranks Alere No. 2 in the point-of-care testing market.
Point-of-Care Diagnostics Market Grows
The point-of-care (POC) diagnostics market reached $18.4 billion in sales in 2016 and is likely to continue growing, according to a new market report by Kalorama Information.
The growth is driven by the paradigm shift toward predictive and personalized medicine, and also by new technologies that provide fast, accurate diagnoses using smartphones, biosensors, lab-on-a-chip and wearable devices. So far, primary care clinicians and generalists most routinely use POC products and devices for pregnancy tests, fecal occult blood tests, dipstick urinalysis, Strep A, Influenza, and mononucleosis tests. Internists and specialists, who have older and sicker patients, drive in-office testing of prothrombin time, panel and individual chemistries, complete blood counts, and endocrinology. Looking to the future, Kalorama Information says the POC market is evolving with growth opportunity. Developing and developed markets alike have room to grow due to an aging population worldwide. Key companies such as Roche, LifeScan, Abbott, and Alere will likely maintain leading positions in the market through continued product innovation and strategic alliances and mergers.
Beckman Coulter Launches New Chemistry Analyzer
Beckman Coulter Diagnostics this month announced the commercial launch of its new DxC 700 AU chemistry analyzer for mid- to high-volume clinical laboratories.
The new platform combines Beckman Coulter's two existing clinical chemistry analyzers, the UniCel DxC and the AU, into one instrument, and runs new operating software that reduces the number of test-processing steps by 30%, the company says. Beckman Coulter designed the new analyzer with an eye toward lowering the cost of ownership; it uses fewer consumables, concentrated reagents, long-lasting ion-selective electrodes, and non-disposable cuvettes. The FDA granted 501(k) premarket approval to the DxC 700 AU in January. It is now available for sale in the United States, and the company intends to expand sales to other countries in 2017.
Fetal Fibronectin a Poor Indicator for Preterm Birth in Low-Risk Pregnancies
The fetal fibronectin (fFN) test is useful when a pregnant woman shows signs of premature labor. A negative result is a strong indicator that she is not likely to deliver in the next two weeks.
However, the test turns out to be of little use as a universal screening tool for asymptomatic women on their first pregnancies. A study published March 14 in the Journal of the American Medical Association found that the fFN test, even when combined with another potentially useful screening technique, detected very few of the women who would go on to have spontaneous preterm delivery. There was no threshold level of fFN at which it functioned as a useful screening test, the authors write.
Kalorama Information's The World Market for Molecular Diagnostics, now in its seventh edition, is a comprehensive study of the molecular diagnostics market. The report is available at: https://www.kaloramainformation.com/Molecular-Diagnostics-Edition-10595682/
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