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What is potential future for Sequenom in prenatal testing.

November 9, 2009

Analysis of:So Where Does Sequenom’s Prenatal Play Currently Stand? | www.genomeweb.com

The historic but minimally supported enthusiasm for the Sequenom prenatal test has previously been reported in this space previously. Even in the absence of data retractions, leading to termination of much of senior management, problems in the rollout of the product should have been anticipated.Remarkably, this article asserts that industry insiders remain optimistic about the development of a successful diagnostic product.

Potential impact of large clinical trial on Liquid based cytology market

November 5, 2009

Analysis of:Alternative to Pap Test Does Not Appear to Be Better for Detecting Cervical Cancer | www.medcompare.com

The data confirms what has long been known. There has never been definitive evidence for a benefit for Liquid based cytology screening compared with conventional screening, especially when sample collection is standardized and the laboratory meets reasonable standards.Objectively, liquid based cytology has essentially replaced conventional Pat testing in this country, and it is unlikely that there is evidence that would reverse this. However, it is possible such studies will put downward pricing pressures on reimbursments, both in amounts and frequencies.

New entrant to DTC genetic testing market raises regulatory and financial questions

July 16, 2009

Analysis of:New DTC Genetics Firm Pathway Genomics Launches | www.genomeweb.com

Pathway Genomics is the latest entrant into the DTC genetic testing market.   They offer an extensive amount of genetic information (over 90 individual results) at a price point of $250.  This undercuts both existing DTC providers, like 23andme, decode genetics, etc., but also appropriately licensed genetics providers.        These companies seem to be threading the needle between providing a service for "research and education only", with extensive legal disclamers, and providing useful information and interpretations which affect medical decisions.  Sooner or later, governmental agencies have to make a decision on whether to clearly subject these companies to explicit regulatory scrutiny, both at the federal and state level.      Notwithstanding, this company would seem poised f

Analyst upgrades of Genomic Health: Lagging or leading indicator

June 12, 2009

Analysis of:Analyst Upgrades Genomic Health | www.genomeweb.com

Genomic Health is a molecular diagnostic company with one major product on the market and others potentially in the pipeline.   Wall street has had only modest coverage of this company and generally assessments have been neutral.  In assessing this company, it is important to recognize that it has some unique positive features in its business model, as well as some downside risks of potentially great magnitude. 

Jumping off the Bandwagon: Decline in Sequenom shares takes world by surprise

May 1, 2009

Analysis of:UPDATE 2-Sequenom delays Down Syndrome test; shares plunge | uk.reuters.com

The market cap of Sequenom has been bid up to the $billion US level by the potential of a single product.   Many in the investment community have been following this closely.  Overwhelmingly, investor sentiment has been bullish, both among the professional investment community, and in the public measures of sentiment (i.e, the motley fool).  Recently, the rug has been pulled out from this company by an announcement that it was delaying the launch of its test for Down's syndrome.  The collapse of the stock, however, should not come as a surprise.  Numerous warning signs were clearly apparent to onlookers familiar with the processes by which new tests become standards of care.  Many of these issues were raised previously in this forum. https://news.glgroup.com/cm/Analysis/PostDetail.aspx?pid=35151

Can DNA testing replace routine PAP smears

April 15, 2009

Analysis of:DNA Test Outperforms Pap Smear | www.nytimes.com

A major study funded by the Bill and Melinda Gates foundation and published in the NEJM  http://content.nejm.org/cgi/content/full/360/14/1385 has concluded that HPV DNA testing outperforms traditional Pap testing in a poor rural setting.  Recommendations to replace Pap testing in women over 30 could have major implications for providers of traditional Pap testing services, for suppliers of reagents and supplies for Pap testing, and for clinicians that order such tests. 

Potential markets for new Roche MRSA test

April 13, 2009

Analysis of:New advanced MRSA test in the EU | www.ptemag.com

Roche has now received CE approval for its MRSA test using real time PCR methodology.  As one of the largest clinical molecular diagnostics companies, Roche clearly is trying to expand its menus and its markets, and build on its installed base.  This product is not yet available in the US.  This product will compete with existing offerings from Becton-Dickinson and with Cepheid. 

Unmet challenges of movement to Electronic Medical Records

March 30, 2009

Analysis of:U.S. Hospitals Slow to Adopt E-Records | online.wsj.com

Fully functional E-records in the non VA and Military Sector have been slow to take hold.  This article ascribes the failure as largely a matter of cost, as well as "resistance" by physicians.   Given the lack of acceptance, and the widespread computerization of most other data bases and operational functions in our society, other factors are probably responsible.  

FDA Approval for HPV tests provides huge opportunity for Hologic

March 16, 2009

Analysis of:FDA OKs Hologic HPV Assays | www.genomeweb.com

The potential upside for Hologic's acquisition of Third Wave Technologies iTWT s now likely to be realized. The test developedby TWT has always had some modest advantages over its competitors.  In the absence of FDA approval, many customers were unwilling to switch from the Quiagen test to the Hologic one. With FDA approval, Hologic should be able to capitalize on its significant advantage in market access over existing competitors (Quiagen) and potential ones (Roche, Gen Probe, BD, Abbott, etc.) by virtue of its market leader status in liquid based pathology (Cytyc) .

Promotion by Sequenom of the company's

March 6, 2009

Analysis of:Sequenom Hires PDI to Launch and Sell Prenatal Test | www.genomeweb.com

The market potential of the SEQureDx pre-natal screening test is mostly likely higher than any single test than anything currently in development.  The test 1) might displace less reliable and invasive technologies, 2) uses proprietary methodologies, 3) has a large and stable ongoing market, 4) if successful, global expansion presents an additional opportunity. Havig said this, there is no guarantee the product will meet the high end of expectations.

US Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group recommendations do not support rapid increase in diagnostic testing based on available evidence and methodologies

January 30, 2009

Analysis of:EGAPP recommendations on three genetic tests | www.phgfoundation.org

The EGAPP working group has produced well researched and documented reommendations for the use of genetic testing in metastatic colorectal cancer, Lynch syndrome, and Breast Cancer.      The absence of clearcut positive recommendations for defined testing strategies and methodologies would seem to suggest significant risk for meeting growth targets for products already in this space.  In a time of potential for cost containment pressure, the absence of strong affirmative recommendations would provide support for those physicians not wanting to use, or insurers not willing to reimburse, some of the affected testing methods.     While these recommendations would appear to provide openings for other entrants on the market, te evaluation indicates the type of scrutiny that new tests will face as they are developed.

Linkage of Molecular pathology test results with diagnostic options

January 6, 2009

Analysis of:Merck Serono: Study Published In JCO Shows Erbitux Enhances Efficacy In MCRC Patients With KRAS Wild-Type Tumors In 1st-Line Setting | www.medicalnewstoday.com

This study is one that adds to an increasing body of evidence linking specific molecular testing to treatments with expensive and potentially dangerous antichemotherapeutic agents.

Impact of restrictions on gifts to MD's on prescribing patterns

August 21, 2007

Analysis of:NY bill would require pharmas to report MD gifts | www.fiercehealthcare.com

Pharmaceutical companies spend over $10,000 per physician on direct gifts and similar activities.  These activities are designed to influence prescribing patterns, and most certainly do.  Monitoring sales of drug classes as drugs come off patent, as in anti allergy medications, drugs for acid reflux, etc, would indicate that physicans rapidly change subscribing patterns in response to combined advertising campaigns, not just scientific evidence. This bill presumes that doctors are innappropriately influenced by gifts, and that eliminating gifts will eliminate the pressure.  In theory, the patient is thus more likely to get the right drug, or the cheaper drug. As in politics, however, it is hard to see that legislation will rapidly get money out of the system.  If there is money to be spent, companies will figure out how to spend it. 

Carrots and sticks to improve patient safety.

August 21, 2007

Analysis of:By 2008, Medicare won't pay for hospital errors | www.fiercehealthcare.com

The last several years as seen the growth of financial incentives to stimulate improvements in patient safety and patient outcomes.  Clearly society has an interest in improving patient safety, and aligning providers and payers financially is a laudable goal. The use of denied payments raises the bar in that rather than rewarding safe practices, presumed unsafe practices are punished.  While plausible this approach has some potential downside (from the hospital/provider point of view): pressure  to underreport errors, messy and perhaps litigious relationships on the definition of medical errors,  a public and high visibility paper trail that might support civil litigation.

Is this the future of laboratory automation

February 28, 2007

Analysis of:GE to acquire Abbott's invitro and point of care diagnostics businesses | egems.gehealthcare.com

How much will Abbott contribute to bottom line of GE.

What is future of Abbott.

Implications of new breast cancer prognostic methodology

February 9, 2007

Analysis of:FDA Approves Test | online.wsj.com

Approval of the Mammaprint is a significant advance clinically, as it is the first FDA approved gene expression test for breast cancer.  If it is widely accepted, it would represent one of the highest value cancer diagnostic products.  The technology would presumably be extended to other common cancers as well.

The Mammaprint is not yet available in the United States, and enters a market with one significant competitor, Oncotype DX.  The latter test is not yet FDA approved, which all things being equal, would put it at a disadvantage for some payers.

From the point of view of the laboratory diagnostic market, this product, and similar ones, have the effect of cutting out a layer of middleman, and thus retaining all profits within the company with rights to the test.  As opposed to the vast majority of lab testing in this country, which is done in commercial or non-profit laboratories, using reagents and instrumentation purchased from manufacturers, this test will presumably be performed as a service in a single location by the company or licensee. 

Non genetic factors determining warfarin dose

January 23, 2007

Analysis of:DNA tests to determine warfarin dose | news.yahoo.com

Using DNA tests to predict appropriate warfarin dosages clearly has market potential.  

However, it is yet to be proven that such testing will significantly reduce the trial and error basis of such, and the article discusses trials that are underway.

It should be noted that the causes of underdoses and overdoses in initial therapy are likely due to interaactions with diet, interactions with other medications, and patient compliance.  

Reaching a stable dose is not just a matter of knowing the "true" genetic response, but of stabilizing the diet, medications, and reliability of the patient.

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