CLIA Waiver for Abaxis' Lipid Profile Tests - Analyst Blog

Abaxis, Inc. ABAX announced the receipt of a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver from the U.S Food and Drug Administration (FDA) for capillary draw for cholesterol (CHOL), high density cholesterol (HDL) and triglycerides (TRIG).  With this waiver, Abaxis has emerged as the only company that provides a capillary or venous CLIA-waived Lipid and Liver panel capable of monitoring statin medications at the point-of-care.

Under CLIA, waived tests must be simple with low probability of erroneous results. The CLIA-waived lipid profile tests that fall under the Piccolo Blood Chemistry Analyzer line are available in a non-lab setting and promise delivery of results in less than 12 minutes, thus helping in speeding up the treatment procedure. Piccolo Blood Chemistry Analyzers, manufactured by Abaxis, deliver on-the-spot routine multi-chemistry and electrolyte results using a small patient sample size in any treatment setting.

Piccolo chemistry analyzers will also facilitate the enhancement of the quality of healthcare services offered globally. By virtue of lab-accurate blood chemistry results delivered on-site within a few minutes, healthcare professionals will be able to take adequately informed decisions in a time- and cost-effective manner. On the whole, we are confident about the efficacy of these tests and expect the recent CLIA-waived status to seamlessly strengthen Abaxis' foothold in the global point-of-care diagnostics market. Moreover, according to the latest report by MarketsandMarkets, this market is expected to reach $27.5 billion by 2018, at a compounded annual growth rate (CAGR) of 9.3% from 2013 through 2018.

Abaxis has an exclusive agreement with Abbott Laboratories ABT, whereby the latter has the rights to sell and distribute the Piccolo Xpress chemistry analyzer and associated consumables in the professional human healthcare market in the U.S. The Piccolo chemistry analyzers fall under the Medical Products segment of Abaxis which contributed 16.3% to the company's total revenue in the first nine months of fiscal 2014.

Currently, Abaxis has a Zacks Rank #5 (Strong Sell). Some better-ranked stocks in the broader healthcare industry are Enzymotec Ltd. ENZY and St. Jude Medical Inc. STJ. Enzymotec sports a Zacks Rank #1 (Strong Buy) while St. Jude Medical carries a Zacks Rank #2 (Buy).