A Medical Device Daily

Compugen (Tel Aviv, Israel) reported the discovery and verification of CGEN-438, a potential blood-based biomarker for lung cancer.

The company described CGEN-438 as "a novel splice variant peptide of delta-like protein 3 precursor (DLL3)." The peptide is secreted from the cell into the bloodstream, whereas the previously known DLL3 is a protein located on the cell membrane.

Compugen said initial clinical evidence indicates that the molecule "could potentially serve as both a serum biomarker for the diagnosis of small-cell lung cancer and as a component in a biomarker combination for the diagnosis of non-small cell lung cancer patients."

Using a test developed by Compugen to detect CGEN-438 in serum, the blood levels of the peptide were measured in about 40 lung cancer patients and healthy individuals. The company said CGEN-438 concentrations detected in serum samples of small-cell lung cancer patients were higher than those detected in controls, demonstrating its potential to become a diagnostic biomarker for small-cell lung cancer.

It said it "also was evident that CGEN-438 is expressed to a large extent in certain non-small cell lung cancer serum samples and therefore may be used in a biomarker combination test for the diagnosis of non-small cell lung cancer as well."

Compugen said it has filed a patent application covering the biomarker.

CGEN-438 is one of a group of possible cancer and cardiovascular biomarkers which was initially predicted in silico using Compugen's immunoassay computational discovery platform, and then further validated experimentally.

"We are ... pleased by the continuing successful validation of molecules with significant commercial potential from the initial group of biomarkers identified by our immunoassay diagnostics discovery platform," said Anat Cohen-Dayag, PhD, VP of diagnostic biomarkers and drug targets at the Israeli company. "In this particular case, although the peptide is a splice variant of DLL3 protein, it shares no sequence similarity to DLL3, thus further demonstrating the unique predictive power of this specific platform and of our in silico prediction and selection discovery capability in general."

He said Compugen will further use the platform "both in our own discovery activities and in collaboration with partners."

India eyes device industry regulations

News reports out of New Delhi, India, indicate that the Indian government is planning to introduce new guidelines for the medical device industry and is working on regulations in discussion with the industry.

"The government is in the process of creating a new and better regulatory structure for the medical devices industry as part of its effort towards achieving quality healthcare for all," Ministry of Health and Family Welfare Joint Secretary Debasis Panda said, addressing a med-tech conference organized by the industry body CII in New Delhi.

The PTI news service report quoted Panda as saying that the government is concerned about the "haphazard" growth of the medical device industry in India, and plans to provide regulations for the industry in the next few months.

"The Health Ministry is working [toward] a switch from a control regime to a regulatory regime to cope with the new technologies and treatments that are now available," Panda said.

The report said the device industry "has been demanding a separate regulatory mechanism for better functioning of the complex industry."

Alok Mishra, area manager-South Asia for Johnson & Johnson, said, "There is an urgent need to understand and regulate the composite and complex medical technology industry."

The PTI report said the domestic medical equipment industry in India is estimated at $2.17 billion, growing at 15% annually. It is estimated to reach $4.97 billion by 2012.

Japanese distribution for OptiMedica

OptiMedica (Santa Clara, California), a developer of ophthalmic devices, said it has expanded into Japan with the formation of an exclusive distribution agreement with Topcon Medical Japan.

Topcon will be the Japanese distributor of OptiMedica's PASCAL (PAttern SCAn Laser) Photocoagulator system, an integrated pattern scan laser designed to treat a variety of retinal diseases — including diabetic retinopathy, age-related macular degeneration and retinal vascular occlusive disease.

OptiMedica said that unlike traditional single-spot photocoagulators, PASCAL offers "a broad spectrum of pattern options that allow delivery of laser pulses in a rapid predetermined sequence, resulting in improved precision, safety and patient comfort as well as a significant reduction in treatment time."

PASCAL was demonstrated at the Topcon booth at the Japanese Academy of Ophthalmology meeting in Yokohama last month.

Topcon Medical Japan, with 10 offices across Japan, is a subsidiary of Topcon Corp., a global maker of optical and electronic instruments. The PASCAL system is distributed in major European markets by sister company Topcon Europe Medical.

SurgiLance included in Nigerian HIV test kit

The SurgiLance safety lancet, a medical safety product manufactured by MediPurpose (Norcross, Georgia), has been selected for inclusion in an HIV kit distributed throughout Africa by Bundi International Diagnostics, a Nigerian company.

Long established in the Americas and Europe, SurgiLance safety lancets are now part of a major testing initiative designed to stem the tide of HIV/AIDS on the African continent.

"This new relationship with Bundi International Diagnostics underscores our commitment to those front-line medical professionals committed to global health initiatives like HIV/AIDS prevention," said MediPurpose CEO Patrick Yi.

"A growing number of test kit manufacturers have chosen the SurgiLance safety lancet for their point-of-care test kits, which are used both in medical facilities and in the field," added Randy Prather, MediPurpose VP for sales and marketing. "In addition to their use in HIV test kits, SurgiLance safety lancets can be used to test for hepatitis and chagas and are commonly used in glucose and cholesterol testing."