Mr. Ken Powell

GLG News by Mr. Ken Powell, President

GLG News is now G+ Insights

G+ is a community for professionals, academics and entrepreneurs to connect through online discussions and in-person meetings. You will continue to see G+ Insights (formerly GLG News) here as well as on the G+ website, where you can share and discuss the G+ Insights you read.

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.

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.

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.

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.

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.

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?

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.

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.

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.

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.

Sequenom searches for success with Down syndrome test

October 18, 2011

Sequenom has finally introduced its storied MaterniT21 Down syndrome test after a two-year delay. The non-FDA approved Laboratory Developed Test (LDT) will need to overcome numerous hurdles to achieve Sequenom’s anticipated level of success.

Point-of-care on the horizon for molecular diagnostic tests

October 17, 2011

Now that more than a dozen leading diagnostic companies have developed automated molecular diagnostic (MDx) systems, a new wave of companies with novel technologies are planning to launch point-of-care (POC) molecular diagnostic tests.  Successful launch of MDx POC assays would enable testing de-centralization and penetration of several high revenue market segments.

Accelr8 Novartis Deal Expires

October 14, 2011

The expiration of Accelr8’s technology evaluation agreement with Novartis is another major setback for Accelr8.  Questions have arisen over its value proposition for 2-hour pathogen detection relative to its competitors. 

Molecular diagnostic tests face new reimbursement hurdles

October 12, 2011

Stricter coverage conditions for molecular diagnostic tests present challenges and risks to labs and new business opportunities for pre-certification processing providers.

Beckman Coulter Receives FDA Warning Letter

September 1, 2011

Analysis of:Warning letter: FDA unleashes laundry list of accusations against Beckman Coulter | www.massdevice.com

Beckman Coulter received a FDA Warning Letter on August 9 informing the company of numerous violations after an audit of its Brea, California manufacturing facility.  This FDA action comes on top of the agency’s Class I recall of the company’s Synchron chemistry analyzer and ongoing problems with its troponin assay.  It hasn’t been a good August for Danaher’s newly acquired business unit.

Sequenom Removes Potential Competitor

August 18, 2011

Sequenom has entered into a license agreement with LifeCodexx subsidiary GATC Biotech to develop a sequence-based trisomy 21 test in Europe. This removes a potential Sequenom competitor and could provide Sequenom with a European revenue stream.

GenMark Making its Mark in Molecular Diagnostics

August 15, 2011

GenMark Diagnostics plans to launch its hepatitis C test later this month and has intends to introduce several other assays by the end of the year.  Both system placements and reagent revenues were up strongly in Q2.

Sequenom Sees Competitor List Grow

August 10, 2011

California based diagnostic company Verinata announced that it has raised $46.5 million in a series C financing round.  Verinata plans to use the proceeds to develop sequencing-based assays for fetal chromosomal abnormalities such as trisomy 21 and 18.  Sequenom will need to compete against yet another player.

Molecular Diagnostics Continues to Drive Growth

August 9, 2011

Molecular diagnostic tests for a variety of disease states continues to drive growth across large, medium and small companies in the clinical diagnostics market.  While the overall IVD market growth is 5-6%, molecular diagnostic segments are growing at 15 to 20+% and offer attractive opportunities.

Vermillion's Road to Success Still Lies Ahead

August 6, 2011

Vermillion Inc. reported a 27% increase on OVA tests sold in Q2 vs. Q1, but the number of OVA1 tests still remains anemically low.  The company estimates cash usage during Q3 at $4 to $5 million and would need to sell 65 to 80,000 OVA1 tests to break even.

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