NEW YORK – Oxford Immunotec said this week it obtained reregistration of its T-Spot.TB test from the Chinese National Medical Products Administration (NMPA) on April 13. The registration remains in place until April 12, 2025, and it will then need to be renewed. The latest reregistration follows a review by the NMPA and an overseas site inspection of the company’s Oxford, UK manufacturing facility.
Inex Innovate said this week it has entered into an agreement with the University of Malaya Medical Centre (UMMC) to provide test kits for the diagnosis of SARS-CoV-2, the virus that causes COVID-19. As of April 21, Inex had supplied more than 20,000 tests to Malaysia-based UMMC. Malaysia has ramped up testing capacity to 11,050 per day compared to 3,000 per day at the end of March, the firm said.
Chembio Diagnostics said this week it has inked a loan agreement with HSBC Bank USA National Association under the paycheck protection program of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The company said in a filing with the US Securities and Exchange Commission that it will receive about $2.98 million from a loan that will mature on April 20, 2022 and have a 1 percent per year interest rate.
Under the terms of the paycheck protection program, certain amounts of the loan may be forgiven if they are used for qualifying expenses described in the CARES Act. Chembio said it anticipates using all loan proceeds for such qualifying expenses. It expects that $2.4 million to $2.7 million of the loan may be forgiven by the US Small Business Administration.
Bionano Genomics last week obtained a two-year, $1.8 million loan at an interest rate of 1 percent per annum under the paycheck protection program of the Coronavirus Aid, Relief, and Economic Security Act.
According to a document filed with the US Securities and Exchange Commission, the US Small Business Association administered the loan and East West Bank issued a promissory note. Bionano's filing also disclosed that on April 15, the firm's board reduced the salaries of certain executives and other employees. Bionano CEO Erik Holmlin, COO Mark Oldakowsi, and CCO Warren Robinson will have their gross monthly salaries reduced by 50 percent for at least two months.
TearLab this week announced that the US Food and Drug Administration has accepted the resubmission of its 510(k) application for potential clearance of its TearLab Discovery MMP-9 test. The submission covers the TearLab Discovery Platform and its single-use disposable test card that measures the inflammatory biomarker, matrix metalloproteinase-9. The TearLab Discovery platform is designed to enable eyecare professionals to assess multiple biomarkers in human tears with nanoliter volume tear collection.
Genetic Technologies this week said it has closed a previously announced offering of 722,502 of its American Depositary Shares (ADSs) at $2 each, bringing gross proceeds to about $1.4 million. Each ADS represents 600 of the Australian molecular diagnostic firm's ordinary shares. The company intends to use the net proceeds from the offering for a few business activities, including supporting the introduction and distribution of its new products in the US.
Epigenomics this week announced that the 2020 National Comprehensive Cancer Network (NCCN) colorectal cancer screening guidelines include Epi proColon, the firm's US Food and Drug Administration approved blood-test for colorectal cancer screening. NCCN updated its 2020 CRC guidelines in a manner consistent with Epi proColon’s FDA-cleared indications, Epigenomics said.
The firm said the new guidelines state that although the blood test is "not recommended for routine screening," it "can be considered for patients who refuse other screening modalities."
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.