GLG News by Economic Experts on Managed Care

Ken PowellPresidentGenesis Business Development, LLC

Clinical lab testing trends

February 7, 2012

Several emerging trends could impact commercial reference lab revenue.  They include developments in pre-certification programs, molecular diagnostic and Laboratory Developed Test (LDT) registries, reimbursement programs and codes and test formularies.

Ken PowellPresidentGenesis Business Development, LLC

New competitor enters ovarian cancer test market

January 26, 2012

Laboratory Corporation of America Holdings (LabCorp ) announced the launch of its FDA-cleared risk stratification tool that aids in the diagnosis of ovarian masses prior to planned surgeries. This new test could be a competitor to Vermillion’s OVA1 which is marketed by partner Quest Diagnostics.

Ken PowellPresidentGenesis Business Development, LLC

Trends in physician office practices

January 17, 2012

American Hospital Association statistics show that the number of physicians employed by hospitals has grown 32% since 2000.  In-office lab testing continues to be strong revenue source for doctors faced with decreasing reimbursement rates.  Mobile connectivity continues to thrive.

Ken PowellPresidentGenesis Business Development, LLC

Clinical diagnostic acquisitions dominate 2011 top ten list

January 12, 2012

Analysis of:Top ten medical device deals of 2011 | www.fiercemedicaldevices.com

Four of the top ten medical device deals in 2011 involved clinical diagnostic companies.  Diagnostic test results have been reported as responsible for over 70% of clinical decisions, so look for continued consolidation in this space in 2012.

Ken PowellPresidentGenesis Business Development, LLC

New competitor plans to enter high growth HPV market

December 8, 2011

San Jose, Calif.-based OncoHealth plans to enter the high growth Human papillomavirus (HPV) market with a new test.  Oncohealth says the assay, to be marketed under the name Oncohealth Direct E6/E7, offers higher specificity than DNA-based HPV assays.  Also it's important to note that the assay’s ELISA technology utilizes readily available immunoassay equipment that does not require expensive molecular diagnostic equipment or personnel to perform the test. This makes it more convenient than DNA-based assays.

Ken PowellPresidentGenesis Business Development, LLC

Medtech M&A activity accelerates in 2011

November 30, 2011

The brisk pace of medtech 2010 M&A activity in all segments accelerated in 2011.  There were 414 M&A transactions in the first 10 months of this year, compared with 262 in the same period in 2010.  What’s in store for 2012?

Ken PowellPresidentGenesis Business Development, LLC

Update on Palmetto's LDT registry and reimbursement

November 17, 2011

Palmetto, one of the largest CMS administrative contractors, appears to be taking the lead regarding Laboratory Developed Test (LDT) registry and reimbursement.  This should be welcomed by public and private groups calling for increased oversight of the rapidly growing list of available LDTs.  Labs marketing LDTs may not welcome Palmetto’s actions as warmly.

Ken PowellPresidentGenesis Business Development, LLC

ISPD Comments on Sequenom's MaterniT21 Test

November 9, 2011

The International Society of Prenatal Diagnosis recently commented on Sequenom’s MaterniT21 test by saying that although it wasn’t fully diagnostic, it could lead to improved prenatal screening. Recent analysts have some hefty revenue projections reminiscent of the ambitious forecast for Vermillion’s OVA1.

Ken PowellPresidentGenesis Business Development, LLC

Gen-Probe's HPV assay cleared by the FDA

October 31, 2011

Gen-Probe expects to enter the competitive HPV market after announcing FDA approval of its Aptima HPV assay.  Gen-Probe will compete against Qiagen, Hologic and Roche.

Ken PowellPresidentGenesis Business Development, LLC

Good news and bad news for Laboratory Developed Tests

October 21, 2011

The controversy over Laboratory Developed Test (LDT) regulations and reimbursement continues, with both positive and not so positive indicators for their future. The ongoing Laboratory Developed Test (LDT) regulatory and reimbursement debates and actions have created high levels of uncertainty for all stakeholders.

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