Results below expectations, perhaps explained by one-time events, were coupled with new product launches and some silver lining in niche markets, as the top two IVD companies announced first-quarter results.  Roche’s Diagnostics division reported sales of $2.9 BN CHF (approx. $2.86 BN USD) and 1% growth, with Molecular Diagnostics as main contributor.  That was flat growth since last year the division grew 5% in the first quarter.

Roche is the world’s largest diagnostic company and its results can speak to the broader market.

The company claimed temporary events and one-time offsets dampened growth, and there were some unusual events in the quarter.  Distributor inventory reduction on point-of-care products in China and one time offsets in tissue diagnostics, also free-of-charge deliveries following the recall of CoaguChek test strips in the fourth quarter.

Within these results, a few events are notable for watchers of diagnostic markets:

  • Roche reported that its molecular Point of Care Sales Up 18%, as cobas Liat finds markets in physician offices and decentralized hospital testing locations.
  • Sales in cervical cancer diagnosis grew 52 percent and sales in blood screening grew 14 percent.
  • While Diabetes care grew 1%, growth was 18% in North America due to recent management care contract wins.
  • While sales in Japan and China were disappointing, EMEA sales were up 3% and Latin America was up 8%.

The company noted several product launches.   The Cobas VivoDx system for antibiotic resistance testing provides results in under 6 hours and can perform 96 tests per 8-hour shift.  NAVIFY mutation profiler combined with NAVIFY therapy matcher both [ph] as a curated knowledge base of genetic fragments to help interpret the clinical significance of the patients and identify suitable therapies. and the VENTANA PD-L1, SP142 Assay, the first FDA companion diagnostic approval for use in first line triple negative breast cancer or TNBC.

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Abbot Diagnostics grew .2% on a reported basis to $1.8 BN dollars, though currency effects clouded otherwise 4.4% organic growth.    Growth was driven by long-term double-digit growth in its Alinity molecular diagnostic platform and other products.  But due to lower flu test revenues , rapid diagnostic revenues, comprising Alere, which Abbott bought in late 2017, decreased 4 percent to $537 million from $559 million.

New products included a CE Mark for Abbott’s Determine HBsAg2 rapid diagnostic assay. highly sensitive, easy-to-use, rapid lateral flow test enables identification of those with.  And the company received a CLIA waiver for their BinaxNOW Influenza A & B Card 2 assay.

 

 

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