Diagnostic Testing & Technology Report

Molecular diagnostics company Agendia (Amsterdam, Netherlands, and Huntington Beach, Calif.) has opened a CLIA-licensed clinical genomics laboratory in Huntington Beach. The 3,500-square-foot facility will perform the company’s molecular diagnostic tests for cancer, including MammaPrint, which predicts the risk of breast cancer recurrence. Agendia also has a clinical laboratory at its Amsterdam headquarters.

A growing number of outreach testing programs across the country are moving to integrate diagnostic services by marketing other services along with laboratory testing, according to the newly released results of the Eighth Annual National Outreach Survey, conducted by Chi Solutions (Ann Arbor, Mich.). In discussing the key trends that emerged from this year’s survey at the 2009 Lab Outreach conference, presented by Washington G-2 Reports (Newark, N.J.) and Chi on June 8-10 in San Diego, Chi Solutions President Kathleen Murphy, Ph.D., singled out “a move toward diagnostics” as an emerging market driver.

Medicare Part B spending on clinical laboratory services continues to increase, with 2008 spending totaling $7.3 billion, an increase of over 3 percent from 2007 totals, according to the latest data from Centers for Medicare & Medicaid Services’s 2009 Medicare Trustees Report. The Medicare program covered a total of 45.2 million enrollees in 2008.

Perlegen Sciences (Mountain View, Calif.), a 2001 spin-off of genetic analysis giant Affymetrix (Santa Clara, Calif.), is gearing up for the fall launch of its first product: a novel genetic test to help determine a patient’s risk of developing breast cancer. On June 4, the company opened a clinical laboratory at its Mountain View headquarters after a successful inspection for CLIA licensure by the California Department of Public Health’s Laboratory Field Services.

The power of data was a key topic at the eighth annual laboratory outreach conference, presented by Washington G-2 Reports (Newark, N.J.) and Chi Solutions (Ann Arbor, Mich.) on June 8-10 at the Hyatt Regency Mission Bay in San Diego. Focused around the theme of “Making Outreach Work: Maximizing Value, Profitability, and Service,” the event brought together clinical laboratory leaders and hospital executives from around the country to discuss the issues, challenges, and significant opportunities in the outreach testing market.

Despite the current recession’s negative impact on hospitals, laboratories that perform outreach testing are seeing boosts in revenue and profitability, according to the results of the Eighth Annual National Outreach Survey, conducted by Chi Solutions (Ann Arbor, Mich.).

A new laboratory-developed test (LDT) from Quest Diagnostics (Madison, N.J.) can assist physicians in determining whether a patient with a history of HIV drug resistance will respond to the class of antiretroviral therapies known as CCR5 antagonist entry inhibitors. Launched on June 12, Quest’s HIV-1 Coreceptor Tropism Test will compete with the market-leading Trofile assay developed and performed by Monogram Biosciences (South San Francisco, Calif.). The new LDT replaces SensiTrop, the HIV tropism test that…

As Clinical Data (Newton, Mass.) sharpens its focus on developing targeted drugs for conditions such as depression, the biotechnology company has achieved significant growth in its pharmacogenomic testing division, PGxHealth. On June 15, Clinical Data reported fiscal 2009 revenues of $10.4 million, an increase of 104 percent over fiscal 2008 revenues of $5.1 million. PGxHealth test revenues for the fiscal year increased 116 percent, jumping from $4.6 million in fiscal 2008 to $9.9 million.

A protein related to aggressive cancers can improve the efficacy of gemcitabine (Gemzar) at treating pancreatic cancer, according to a study published in the June issue of Cancer Research.

Anatomic pathology and molecular testing laboratory Clarient, Inc. (Aliso Viejo, Calif.), has launched a laboratory-developed test (LDT) that can help physicians select the proper therapy for patients with non-small cell lung cancer (NSCLC) by detecting mutations in the epidermal growth factor receptor (EGFR) gene.

A genetic analysis of data from three studies suggests that genetically elevated levels of lipoprotein(a) are associated with an increased risk of heart attack (myocardial infarction), according to a study published in the June 10 issue of the Journal of the American Medical Association.

While clinical laboratories nationwide continue to report plummeting rates of drugs-of-abuse testing, Inverness Medical Innovations (Waltham, Mass.) is looking to expand its presence in the market. On June 5, the company announced its proposed acquisition of Concateno (London), a leading European provider of drugs-of-abuse testing and a manufacturer of diagnostic tests.

Under Senate legislation introduced on June 9, independent laboratories offering complex, advanced diagnostic tests would be allowed to bill Medicare directly for the tests when ordered less than 14 days after a patient’s discharge from the hospital.

Myriad Genetics (Salt Lake City), best known for developing and marketing the BRACAnalysis test for hereditary breast and ovarian cancer, is moving forward with its plan to spin off its pharmaceutical business from its core molecular diagnostics business. At a meeting on June 4, the company’s board of directors set the shareholder of record and distribution dates in connection with the spin-off. The transaction cleared a key regulatory hurdle a week later, when the Securities and Exchange Commission declared effective Myriad Pharmaceuticals’ registration statement on Form 10.

Anatomic pathology provider PLUS Diagnostics (Lakewood, N.J.) continues to expand with the opening of a 15,000-square-foot West Coast facility in Orange County, Calif. The new laboratory will serve as a base for the company’s launch of hematology and oncology testing services by the end of 2009.

The number of physician office laboratories (POLs) that perform testing classified as waived or provider-performed microscopy under CLIA is projected to grow by 3.5 percent in the fiscal year 2009 to 2010 survey cycle, according to the president’s recent budget proposal for the Centers for Medicare and Medicaid Services.

A nonprofit charitable group can help financially needy Medicare and Medicaid patients pay their cost-sharing amounts for advanced diagnostic testing used in treating HIV and colon cancer without risking federal civil penalties, the Department of Health and Human Services Office of Inspector General (OIG) said in a new advisory opinion.

The G-2 Diagnostic Stock Index is up for the third consecutive month, having gained an average of 6 percent in the five weeks ended June 5, with 10 stocks up in price, five down, and one unchanged. The G-2 index has gained 12 percent so far this year, while the Nasdaq is up 18 percent and the S&P has lost 6 percent.

Would cancer patients choose to undergo genetic testing to predict their disease prognosis, even if no treatments were available for the condition? Yes, according to a study published in the June issue of the Journal of Genetic Counseling. Researchers from the University of California Los Angeles surveyed 99 patients who had been diagnosed with ocular melanoma. The perceived usefulness of prognostic information was then evaluated in all patients, including a subset that had undergone cytogenetic testing for the genetic marker most strongly linked to rapid metastatic disease. Patients whose tumors show loss of a copy of chromosome 3 have at least a 50 percent chance of death within five years. Aggressive cases can result in blindness and death in as quickly as a year.