A Diagnostics & Imaging Week

The Centers for Medicare & Medicaid Services has confirmed that it will not authorize payment for the Heartsbreath test, manufactured by Menssanna Research (Newark, New Jersey) after determining "that the evidence does not adequately define the technical characteristics of the test nor demonstrate that Heartsbreath testing to predict heart transplant rejection improves health outcomes."

Menssana had proposed coverage of the diagnostic in 2006, but had difficulty in gaining traction with the agency until last year, when CMS opted to look the proposal over. The agency's proposed coverage decision was posted in October, and nothing happened in the interim to change the agency's thinking.

The Heartsbreath test, as the name suggests, detects volatile organic compounds (VOCs) in the breath of patients who have undergone a heart transplant, which Menssana proposed served as an index of tissue rejection.

According to CMS's earlier postings, the pivotal PMA study for the Heartsbreath, the HARDBALL (Heart Allograft Rejection; Detection with Breath Alkanes in Low Levels) study did little to suggest the usefulness of a determination of grade 3 tissue rejection, "especially given the controversy in the transplant community regarding what grade of rejection should indicate a change in clinical management." CMS also had reservations over the utility of the VOCs as biomarkers of rejection, stating in the proposed decision memo of October that "it is unclear if these specific VOCs are representative of grade 3A rejection in all patients or are representative of only the sample of patients" in the study.

The application certainly did not fail for lack of effort. Michael Phillips, MD, President of Menssana, wrote in a Nov. 18, 2006, letter to CMS that he'd had no luck with local coverage contractors "in several states, particularly in New York and New Jersey" after being advised to pursue such a course by administrators at CMS. After efforts he described as "ultimately fruitless," Phillips said "I was ultimately told that I should now return to CMS in order to pursue an NCD." Hence, "I have therefore now come full circle back to CMS."

Phillips had not responded to calls for comment at press time.

NIH releases technologies for licensing

The National Institutes of Health has published a notice in the Federal Register regarding technologies it will license to industry, and the list is heavily populated with diagnostics. Makers of imaging equipment might be especially interested in several of the offerings.

According to the Feb. 23 edition of the FR, NIH is willing to license a new real-time polymerase chain reaction array "that allows for simultaneous transcriptional profiling of the human herpesvirus HHV6A genome," a tool that could be used to determine the "contribution of HHV6A to the development" of lymphomas and other cancers when an infectious agent is suspected.

Another item of interest – this one to makers of imaging equipment – is a patent for an electron paramagnetic resonance (EPR) "image formation strategy for in vivo imaging of physiological functions." According to the notice, single-point imaging with EPR can track tissue oxygenation to help plan radiation and chemotherapy doses. This approach to tissue imaging is said to offer the high contrast found in spin-echo Fourier imaging along with the "super-high resolution" of the single-point methodology, which offers "reliable EPR imaging for tissue physiological function in vivo."

NIH also is making available a technique for navigation of the large intestine that allows more precise registration of polyps by using the locations of bands of muscle in the colon as grids. The teniae coli are described as "three equal-distanced bands of longitudinal smooth muscle on the surface of the colon," which can be used as reference points to assist in coordinating images drawn from the patient in face-down and face-up positions. The document does not state how much of an improvement the teniae coli reference system is over other mapping approaches, but states that the technology "allows for more detailed detection of anatomical features for surgical planning, better camera orientation" and "more efficient lesion registration."

Not to be left out, makers of vaccines may want to look into a technology that "relates to compositions and methods for improving the growth characteristics of cells engineered to produce live viruses."

NIH researchers have come up with a means by which vaccine makers can convert Madin-Darby canine kidney cells "into a suspension culture" which provides an alternative to chicken eggs as a medium for virus production. According to the Federal Register notice, the technology can "improve yields and reduce the cost" thanks to the insertion of an unspecified human gene, which apparently has the effect of improving growth and adhesion characteristics as well as cell density growth and hemagluttin production.

Sibelius seen as likely HHS pick

The Obama administration is into the second round of nominees for the position of Secretary of Health and Human Services, and Kansas Gov. Kathleen Sibelius, a Democrat, is the object of rumors that she will run the vetting gauntlet next.

Sibelius has credentials where healthcare issues are concerned, given the eight years she served as the state's insurance commissioner and another six years running Kansas' state Medicaid program. She is widely seen as working very effectively across political divides.

Her success may or may not be assured, assuming she is nominated, but absent any financial imbroglios, she seems an almost sure bet.

Also on tap at HHS is the FDA commissioner position, a slot generally believed to hinge on the appointment of the HHS job. On the other hand, more bad news about drugs and food could override that sequence. The peanut salmonella problem and the recent disclosure that Raptiva (efalizumab), a treatment for severe placque psoriasis, has been linked to as many as four incidents of progressive multifocal leukoencephalopathy in the U.S. and Europe, puts a sense of urgency in the search for an FDA commissioner.

Baltimore Health Commissioner Joshua Sharfstein and Margaret Hamburg are frequently touted as the prime candidates. Hamburg served in a policy advisory role in the Clinton administration and as a health commissioner for New York City. The name of Steve Nissen, MD, a cardiologist at the Cleveland Clinic (Cleveland) and a frequent critic of FDA's regulation of the drug industry, seems to have dropped from view where the FDA post is concerned.

No Comments